Efficacy and tolerability of an ulcer compression stocking for therapy of chronic venous ulcer compared with a below-knee compression bandage: results from a prospective, randomized, multicentre trial. A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers. A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers. Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers. The influence of different sub-bandage pressure values on venous leg ulcers healing when treated with compression therapy. Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers. Comparison of the effectiveness of compression stockings and layer compression systems in venous ulceration treatment. Evaluation of SurePress Comfort: a new compression system for the management of venous leg ulcers. A randomized trial of the Tubulcus multilayer bandaging system in the treatment of extensive venous ulcers. Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. Sequential gradient pneumatic compression enhances venous ulcer healing: a randomized trial. A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers. Combination of hydrocolloid dressing and medical compression stockings versus Unna's boot for the treatment of venous leg ulcers. Comparison of elastic versus nonelastic compression in bilateral venous ulcers: a randomized trial. Comparison of low-strength compression stockings with bandages for the treatment of recalcitrant venous ulcers. Intermittent pump versus compression bandages in the treatment of venous leg ulcers. Intermittent pneumatic compression improves venous ulcer healing. Randomized trial of four-layer and two-layer bandage systems in the management of chronic venous ulceration. Comparison of the healing rates and complications of three four-layer bandage regimens. An evaluation of Hyalofill-F plus compression bandaging in the treatment of chronic venous ulcers. The influence of dressings on venous ulcer healing--a randomised trial. Monitoring the microcirculation to evaluate dressing performance in patients with venous leg ulcers. Short-stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates. Setopress vs Elastocrepe in chronic venous ulceration. Comparison of two occlusive bandages in the treatment of venous leg ulcers. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Human Skin Equivalent Investigators Group. [The impact of the sonotherapy and compression therapy on enhancement of healing venous leg ulcers after surgical treatment]. Trial of two bandaging systems for chronic venous leg ulcers. [Healing of venous leg ulcers. A randomized prospective study of a long-stretch versus short-stretch compression bandage]. A prospective, randomized trial of Unna's boot versus Duoderm CGF hydroactive dressing plus compression in the management of venous leg ulcers. Randomised, comparative study of three primary dressings for the treatment of venous ulcers.
To investigate the possibility of improving healing rates in ulcus cruris venosum by using an ulcer compression stocking (U-Stocking) (Venotrain ulcertec) as compared to compression bandages. RESEARCH DESIGN AND SETTING: Prospective, multicentre, open-labelled, randomized, active-controlled study with blinded assessment of the primary endpoint. Sixteen phlebology outpatient clinics in Germany or the Netherlands or German medical practices specialized in phlebology.
                134 patients with venous leg ulcers entered the study. Among others, patients with infected ulcer or obesity were excluded. 121 patients were eligible for primary efficacy analyses. U-Stocking or bandages applied for at least eight hours per day and for up to 12 weeks. The primary endpoint was the healing rate after 12 weeks as assessed by planimetric measures. The secondary outcome variables were time to healing, changes in ulcer size (planimetry), experience of use and patient compliance.
                Therapy with the U-Stocking produced a significantly higher rate of complete healing of 47.5% (29/61) versus 31.7% (19/60) with bandages, 1-sided p = 0.0129 [CI: 95% for differences: 4.3% to 28.5%]. Mean time to healing was 46 days in both groups. Time required for application of the U-Stocking was a mean of 5.4 min (SD 5.4) versus 8.5 min (SD 6.5) for bandages, p = 0.0001. Around three patients in each treatment group were affected by serious adverse events. All treatment-related adverse events are known for compression therapy.
                The U-Stocking was superior to bandages in compression therapy for venous ulcer. This is of significance to new treatment standards as well as to future studies of longer term therapy (> 12 weeks) for unhealed ulcers or prevention of recurrence. This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB. This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL. Many venous ulcers are healed by the application of external compression. It has been suggested that bandages capable of producing greater compression enhance healing. The aim of this study was to compare the time to total healing of venous ulcers in two groups of patients treated with different compression regimens in a randomized prospective trial.
                A total of 112 patients was studied and all were treated with a zinc-impregnated paste bandage applied directly to the ulcer. Fifty-seven patients had the paste covered by Tensopress and 55 by Elastocrepe bandages. Both groups had a tubular bandage applied over the top to retain the bandage in place. All ulcers were stratified and randomized within one of three size groups. The 'venous' aetiology of the ulcer was confirmed on completion by calf pump function tests.
                By 26 weeks, 58 per cent of the patients treated with Tensopress and 62 per cent of those treated with Elastocrepe bandages were healed. The median healing times were 9 and 9.5 weeks respectively. Similar numbers of patients were excluded or withdrawn from both groups. Large ulcers healed significantly more slowly than small ulcers.
                There was no significant improvement in venous ulcer healing using higher compression elastic bandages. Venous leg ulcers (VLU) have a huge social and economic impact. An estimated 1.5% of European adults will suffer a venous ulcer at some point in their lives. Despite the widespread use of bandaging with high pressure in the treatment of this condition, recurrence rates range between 25% to 70%. Numerous studies have suggested that the compression system should provide sub-bandage pressure values in the range from 35 mm Hg to 45 mm Hg in order to achieve the best possible healing results.
                An open, randomized, prospective, single-center study was performed in order to determine the healing rates of VLU when treated with different compression systems and different sub-bandage pressure values. One hundred thirty-one patients (72 women, 59 men; mean age, 59-years-old) with VLU (ulcer surface >3 cm(2); duration >3 months) were randomized into three groups: group A - 42 patients who were treated using an open-toed, elastic, class III compression device knitted in tubular form (Tubulcus, Laboratoires Innothera, Arcueil, France); group B - 46 patients treated with the multi-component bandaging system comprised of Tubulcus and one elastic bandage (15 cm wide and 5 cm long with 200% stretch, Niva, Novi Sad, Serbia); and group C - forty-three patients treated with the multi-component bandaging system comprised of Tubulcus and two elastic bandages. Pressure measurements were taken with the Kikuhime device (TT MediTrade, Soro, Denmark) at the B1 measuring point in the supine, sitting, and standing positions under the three different compression systems.
                The median resting values in the supine and standing positions in examined study groups were as follows: group A - 36.2 mm Hg and 43.9 mm Hg; group B - 53.9 mm Hg and 68.2 mm Hg; group C - 74.0 mm Hg and 87.4 mm Hg. The healing rate during the 26-week treatment period was 25% (13/42) in group A, 67.4% (31/46) in group B, and 74.4% (32/43) in group C. The success of compression treatment in group A was strongly associated with the small ulcer surface (<5 cm(2)) and smaller calf circumference (CC; <38 cm). On the other hand, compliance in group A was good. In groups B and C, compliance was poor in patients with small CC, but the healing rate was high, especially in patients with large ulcers and a large CC (>43 cm).
                The results obtained in this study indicate that better healing results are achieved with two or multi-component compression systems than with single-component compression systems and that a compression system should be individually determined for each patient according to individual characteristics of the leg and CC. Target sub-bandage pressure value (B1 measuring point in the sitting position) of the compression system needed for the ulcer healing could be determined according to a simple formula, CC + CC/2. Aim of the study was to compare the healing rates of venous ulcers obtained with four-layer bandages (4LB) versus short stretch bandages (SSB).
                Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore Austrian Dutch Study).
                112 patients (53 treated with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the study. Bandaging and ulcer assessment was performed at weekly intervals. Randomisation was carried out for each centre and was stratified according to the size (more or less than 10 cm2) of the ulcerated area. Local therapy consisted of plain absorbing, non-adherent dressings. Time to complete healing was recorded up to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics.
                In total 33/53 (62%) of ulcer-patients were healed in the 4LB group, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI -28% to 7%). 77% of the ulcers with an initial area less than 5 cm2 healed as compared with 33% of the larger ulcers. The different healing rates in the centres could be explained by the different sizes of the treated ulcers. Based on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% CI 47-85 days) and 63 days for the SSB (95% CI 43-70 days).
                The ulcer healing rate and the median healing time did not differ among the two types of bandages. The main discriminant criterion for healing was the initial ulcer size. In centres who are experienced users of short-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB. The aim of the research was to compare the dynamics of venous ulcer healing when treated with the use of compression stockings as well as original two- and four-layer bandage systems.
                A group of 46 patients suffering from venous ulcers was studied. This group consisted of 36 (78.3%) women and 10 (21.70%) men aged between 41 and 88 years (the average age was 66.6 years and the median was 67). Patients were randomized into three groups, for treatment with the ProGuide two-layer system, Profore four-layer compression, and with the use of compression stockings class II. In the case of multi-layer compression, compression ensuring 40 mmHg blood pressure at ankle level was used.
                In all patients, independently of the type of compression therapy, a few significant statistical changes of ulceration area in time were observed (Student's t test for matched pairs, p < 0.05). The largest loss of ulceration area in each of the successive measurements was observed in patients treated with the four-layer system - on average 0.63 cm2/per week. The smallest loss of ulceration area was observed in patients using compression stockings - on average 0.44 cm(2)/per week. However, the observed differences were not statistically significant (Kruskal-Wallis test H = 4.45, p > 0.05).
                A systematic compression therapy, applied with preliminary blood pressure of 40 mmHg, is an effective method of conservative treatment of venous ulcers. Compression stockings and prepared systems of multi-layer compression were characterized by similar clinical effectiveness. The primary aim was to compare the healing of venous leg ulcers after management with either a new compression stocking (SurePress Comfort, ConvaTec) or a standard short-stretch bandage system (Comprilan, BSN Medical GmbH & Co). Secondary parameters included healing rate, ease of application and removal, comfort during wear, local pain levels and concordance.
                This was a prospective multicentre open-label comparative randomised controlled parallel-group pilot trial of 12 weeks' duration.
                The proportion of ulcers that healed in 12 weeks (44.4% versus 17.2%, p=0.027) and the average time to healing (72 +/- 5 days versus 101 +/- 7 days, p=0.0265) were significantly better with SurePress Comfort than the comparator. All the secondary parameters (except concordance) also showed statistically significant differences for the stocking over the comparator.
                SurePress Comfort stocking system is more effective than a standard short-stretch compression bandage in healing venous leg ulcers and in reducing associated pain. It is well accepted by patients due to its ease of use and comfort, and its safety profile is comparable to that of a standard compression system. It may therefore provide an effective solution for the delivery of graduated compression and has the potential to improve concordance, compared with short- stretch bandages.
                This study was sponsored by ConvaTec. Venous ulcers are a major health problem because of their high prevalence and associated high cost of care. Compression therapy is the most widely used treatment for this condition. The vast majority of published articles on compression therapy present the results in the treatment of venous ulcers usually up to 15 to 20 cm(2). However, there are no published data in English medical literature on the efficacy of compression therapy in the treatment of extensive venous ulcers (ulcers >20 cm(2) of more than 6 months' duration) with regard to healing rate, time to healing, and recurrence rate at 12 months after healing.
                A total of 138 patients with extensive venous ulceration (ulceration surface, 20-210 cm(2); duration, 7 months to 28 years) were randomized into 2 groups: (1) a treatment group (72 patients who were treated by using a multilayer bandaging system with the Tubulcus (a heelless open-toed elastic compression device knitted in tubular form) and elastic bandages and (2) a control group (66 patients treated with a multilayer bandaging system with elastic bandages only). The patients were treated on an ambulatory basis; the primary end point of the study was complete ulcer healing at 500 days. The secondary end point was to assess the ulcer recurrence rate during continuation of below-knee compression of different degrees of compression. In the treatment group, patients were instructed to continue to wear the Tubulcus (35 mm Hg), and patients in the control group were instructed to wear compression stockings with compression of 20 to 25 mm Hg. The exclusion criteria from the study were heart insufficiency with an ejection fraction <35, an ankle-brachial pressure index less than 0.8, and pregnancy.
                The cumulative healing rate was 93% in the treatment group and was 51% in the control group (P < .001). The median healing time in the treatment group was 133 days (range, 28 to 464 days), and in the control group it was 211 days (range, 61 to 438 days). The recurrence rate at 12 months in the treatment group was 24% (16/67) and was 53% (18/34) in the control group (P < .05). After additional compression treatment with the same treatment protocol, all 16 recurrent ulcers in the treatment group healed. In the control group, the healing rate of recurrent ulcers was 89% (16/18).
                This study suggests that for extensive venous ulceration, multilayer compression therapy with the Tubulcus provides an extremely high healing rate. Compression of more than 30 mm Hg results in decreased ulcer recurrence. However, recurrence cannot be completely avoided. A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index < 0.8) and causes of ulceration other than venous disease were excluded. For patients with bilateral ulceration, the limb with the larger area of ulceration was studied. Patients were randomized to receive either type of compression bandage and simultaneously randomized to one of two foam dressings that were changed weekly unless more frequent changes were clinically required. In all, 156 patients met entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33-123.10) cm(2). Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration, and one patient had died. Of the 74 patients randomized to the four-layer bandage, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on the cohesive short-stretch system. Intention-to-treat analysis produced a hazard ratio for healing of 1.08 (95 percent CI 0.63-1.85, p= 0.79). Withdrawal rates were similar between groups (15, 20% four-layer bandage; 17, 21% cohesive short-stretch system). Ulcer closure rates for patients treated with the cohesive short-stretch system were similar to those for patients managed by the four-layer bandage system in this trial. The treatment of venous ulcers has remained largely unchanged for centuries. The application of properly applied graduated compression bandages, the use of graduated compression stockings, and surgery have been shown to achieve healing. However, some ulcers persist despite appropriate management. A randomized study was undertaken to compare two regimens of treatment for such patients. Both regimens included ulcer debridement, cleaning, nonadherent dressing, and graduated compression stockings. In one regimen, sequential gradient intermittent pneumatic compression was applied for 4 hours each day. Only one of 24 patients in the control group had complete healing of all ulcers compared with 10 of 21 patients healed in the intermittent pneumatic compression group. The median rate of ulcer healing in the control group was 2.1% area per week compared to 19.8% area per week in the intermittent pneumatic compression group. The results indicate that sequential gradient intermittent pneumatic compression is beneficial in the treatment of venous ulcers. We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration.
                A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat.
                There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0).
                Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings. Various therapeutic approaches have been developed to manage venous ulcers. In this study the effectiveness of a hydrocolloid dressing (Comfeel Ulcer Dressing) in comparison to the Unna boot, the prototype of rigid bandages, was evaluated.
                Design: Prospective, comparative study.
                University hospital.
                Sixty patients diagnosed with post-thrombotic chronic venous insufficiency with venous ulcers were randomly assigned to two groups of 30 patients. Interventions: In group A, the Unna boot, and in group B, hydrocolloid dressing in addition to the elastic compression were used. Measures: The two groups were compared in terms of 1) complete healing, 2) weekly wound surface reduction, 3) time to complete healing, 4) performance characteristics (ease-of-use score), 5) pain during application and at home, 6) application time.
                The duration of the ulcers was 16.6 +/- 5.8 weeks in group A and 16.9 +/- 6.2 in group B (p >0.05). Previous ulcer recurrence was 74% (20/27 patients) in group A and 73% (19/26 patients) in group B (p >0.05). The initial ulcer size was 6.38 +/- 1.2 cm2 in group A and 6.19 +/- 0.8 cm2 in group B (p >0.05). The complete healing rates were 74.07% (20/27) in group A and 80. 76% (21/26) in group B (p >0.05). The weekly wound surface reductions were 1.28 +/- 0.72 cm2/week and 1.16 +/- 0.38 cm2/week in groups A and B, respectively (p >0.05). The ulcer healing time was 6.85 +/- 3.60 weeks in group A, whereas it was 6.65 +/- 3.31 weeks in group B (p >0.05). Ease-of-use score was 9.04 +/- 2.38 in group A and 17.27 +/- 3.27 in group B and the difference was significant (p <0.0001). A higher degree of pain was reported by the patients who were treated with the Unna boot, both during application (group A 3.69 +/- 1.35, group B 1.88 +/- 1.48, p <0.0001) and at home (group A, 3.27 +/- 1.08, group B, 1.88 +/- 1.11, p <0.0001). The average time spent on Unna boot changes was 150.59 +/- 34.73 min, compared to 134.54 +/- 43.39 min in group B (p >0.05).
                These results demonstrate the superiority of hydrocolloid dressing plus elastic compression treatment in terms of patient convenience. There is controversy regarding the effectiveness of elastic vs nonelastic compression in the healing of venous leg ulcers. To gain insight into this controversy, we randomly compared a four-layer elastic bandage with a nonelastic garment (CircAid) in patients with venous leg ulcers.
                Twenty-four extremities of 12 patients with bilateral leg ulcers were randomized to have a four-layer elastic bandage in 1 extremity and a nonelastic compression garment CircAid in the contralateral limb. The CEAP classification in 22 extremities was C(6 S); ES; A(D6,14,15,P18); PR; 1 extremity in 2 patients was C(6 S); E(S); A(D 6,14,15,P18); PRO. There were seven men and five women. Age ranged from 45 to 82 years, with a mean of 61 years. All patients had postthrombotic leg ulcers diagnosed clinically by duplex ultrasonography (n = 8) or by phlebography (n = 4). Every 4 weeks, patients had the ulcer area measured in square centimeters by a computerized scanning method and had the limb girth measured in centimeters at the foot, ankle, and calf. The ankle-brachial index was determined in all cases. Color photographs of the ulcer areas were taken monthly to assess healing progress. All patients were compliant. Results were assessed at 12 weeks. A patient satisfaction sheet was filled out by the patient, who circled one of the following scores: 3, very satisfied; 2, moderately satisfied; and 1, not satisfied. Cox proportional hazards models or paired t tests were used for comparison.
                The 24 limbs were randomized and divided into 2 groups of 12 each. Group A received CircAid, and group B, a four-layer elastic bandage. Duplex scanning showed a pattern of reflux in 11 limbs of each group. One limb in each group had a pattern of obstruction documented by air plethysmography (n = 2). Phlebography demonstrated the anatomic site in both limbs. The initial ulcer area in group A was 48.98 +/- 14.13 cm2 and was 50.08 +/- 18.30 cm2 in group B (P = .9285). The ulcer healing rate was significantly faster in group A compared with group B (hazard ratio, 0.56; 95% confidence interval, 0.33-0.96; P = .0173). Ulcers with hemodynamic obstruction had a protracted course when compared with the contralateral limbs with reflux. There was no significant difference in girth reduction between groups A and B (hazard ratio, 2.36; 95% confidence interval, 0.30-18.52; P = .3580). The ankle-brachial index was normal (> or = 1.0) in all patients.
                In compliant patients, venous leg ulcers randomized to nonelastic compression had a significantly faster healing rate per week than ulcers treated by the conventional four-layer compression system. To compare the proportion and rate of healing, pain, and quality of life of low-strength medical compression stockings (MCS) with traditional bandages applied for the treatment of recalcitrant venous leg ulcers.
                A single-center, randomized, open-label study was performed with consecutive patients. Sigvaris prototype MCS providing 15 mm Hg-25 mm Hg at the ankle were compared with multi-layer short-stretch bandages. In both groups, pads were placed above incompetent perforating veins in the ulcer area. The initial static pressure between the dressing-covered ulcer and the pad was 29 mm Hg and 49 mm Hg with MCS and bandages, respectively. Dynamic pressure measurements showed no difference. Compression was maintained day and night and changed every week. The primary endpoint was healing within 90 days. Secondary endpoints were healing within 180 days, time to healing, pain (weekly Likert scales), and monthly quality of life (ChronIc Venous Insufficiency Quality of Life [CIVIQ] questionnaire).
                Of 74 patients screened, 60 fulfilled the selection criteria and 55 completed the study; 28 in the MCS and 27 in the bandage group. Ulcers were recurrent (48%), long lasting (mean, 27 months), and large (mean, 13 cm2). All but one patient had deep venous reflux and/or incompetent perforating veins in addition to trunk varices. Characteristics of patients and ulcers were evenly distributed (exception: more edema in the MCS group; P = .019). Healing within 90 days was observed in 36% with MCS and in 48% with bandages (P = .350). Healing within 180 days was documented in 50% with MCS and in 67% with bandages (P = .210). Time to healing was identical. Pain scored 44 and 46 initially (on a scale in which 100 referred to maximum and 0 to no pain) and decreased within the first week to 20 and 28 in the MCS and bandage groups, respectively (P < .001 vs .010). Quality of life showed no difference between the treatment groups. In both groups, pain at 90 days had decreased by half, independent of completion of healing. Physical, social, and psychic impairment improved significantly in patients with healed ulcers only.
                Our study illustrates the difficulty of bringing large and long-standing venous ulcers to heal. The effect of compression with MCS was not different from that of compression with bandages. Both treatments alleviated pain promptly. Quality of life was improved only in patients whose ulcers had healed.
                Copyright 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved. The purpose of the present paper was to compare healing rate and leg swelling with an intermittent compression pump versus compression bandages in the treatment of venous leg ulcers, and to also compare patient compliance and satisfaction with the two techniques.
                A randomized cross-over study of patients attending an outpatient wound clinic (n = 16) was undertaken. A regular monthly follow-up with measurement of ulcer size and leg volume was carried out, as well as completion of a questionnaire.
                Assessment was possible in 11 of the 16 patients. There was no significant difference between treatment types with regards to ulcer healing rates or control of leg oedema. The survey revealed that patients found the pump easier and more comfortable to use, with a trend towards increased compliance.
                Although the present study was too small for generalizable conclusions, compression pumps and bandages are comparable in efficacy for the healing of venous leg ulcers. The compression pump is reported as being easier and more comfortable to use than bandages. The effects of intermittent pneumatic compression on the healing rates of ulcers in patients with chronic venous insufficiency were examined in a prospective, controlled study of 22 patients. Patients were randomly assigned to the experimental or the control group. Both groups received local wound care followed by application of an Unna boot. In addition, subjects in the experimental group received intermittent pneumatic compression (IPC) twice weekly for one hour each session. Healing rates were reported in square centimeters per day. Data analysis revealed a mean healing rate of 0.08 cm2 per day for control subjects and 0.15 cm2 per day for experimental subjects. Statistical analysis, demonstrated the healing rates of the two groups to be statistically different. The results appear to indicate that intermittent pneumatic compression is beneficial in the management of venous insufficiency ulcers. To compare a four-layer bandage system with a two-layer system in the management of chronic venous leg ulceration, a prospective randomized open parallel groups trial was undertaken. In total, 112 patients newly presenting to leg ulcer services with chronic leg ulceration, screened to exclude the presence of arterial disease (ankle brachial pressure index <0.8) and causes of ulceration other than venous disease, were entered into the trial. Patients were randomized to receive either four-layer (Profore) or two-layer (Surepress) high-compression elastic bandage systems. In all, 109 out of 112 patients had at least one follow-up. After 24 weeks, 50 out of 57 (88%) patients randomized to the four-layer bandage system with follow-up had ulcer closure (full epithelialization) compared with 40 out of 52 (77%) on the two-layer bandage, hazard ratio = 1.18 (95% confidence interval 0.69-2.02), p = 0.55. After 12 weeks, 40 out of 57 (70%) patients randomized to the four-layer bandage system with follow-up had ulcer closure compared with 30 out of 52 (58%) on the two-layer bandage, odds ratio = 4.23 (95% confidence interval 1.29-13.86), p = 0.02. Withdrawal rates were significantly greater on the two-layer bandage (30 out of 54; 56%) compared with the four-layer bandage system (8 out of 58; 14%), p < 0.001, and the number of patients with at least one device-related adverse incident was significantly greater on the two-layer bandaging system (15 out of 54; 28%) compared with four-layer bandaging (5 out of 54; 9%), p = 0.01. The higher mean cost of treatment in the two-layer bandaging system arm over 24 weeks ($1374 [ pound 916] vs. $1314 [ pound 876]) was explained by the increased mean number of bandage changes (1.5 vs. 1.1 per week) with the two-layer system. In conclusion, the four-layer bandage offers advantages over the two-layer bandage in terms of reduced withdrawal from treatment, fewer adverse incidents, and lower treatment cost. This randomised controlled study compares the healing rates, complications and patient and staff acceptability of three four-layer bandage regimens for leg ulcers. A total of 149 patients were recruited into the study, of whom 50 received the original Charing Cross system (CX4L), 50 a modified Charing Cross system (Parema) and 49 a commercially available kit, Robinson Ultra Four (Robinson). No significant difference was found in the healing rates of the three systems. Overall 12 weeks' healing was 65%, while the 20-week healing rates for the individual systems were 87% (CX4L), 84% (Parema) and 83% (Robinson). Analysis of known risk factors for delayed healing showed that no bandaging system had an advantage over the others. Staff familiarity resulted in an initial preference for the CX4L but there was no bandage preference by the end of the study. The data suggest that none of the systems has an advantage over the others and that cost savings can be made by pursuing a competitive pricing policy. Hyaluronan, a component of the extracellular matrix, plays a significant role in several aspects of tissue repair and the wound healing process.
                In this Italian study Hyalofill-F, a partial benzyl ester derivative of hyaluronan, used in combination with compression bandaging, was compared with the well-established therapy in Italy of non-adherent gauze plus compression therapy in the treatment of chronic venous leg ulcers.
                Hyalofill-F plus compression bandaging performed significantly better than non-adherent gauze plus compression bandage in all of the clinically relevant efficacy parameters. Mean reduction in ulcer area in the hyaluronan-derivative group was 8.1 cm2 after eight weeks of treatment, compared with 0.4 cm2 in the comparator group. The resulting difference of 7.7 cm2 between the two groups was statistically significant (p = 0.0019). Furthermore, statistically significant results in favour of the hyaluronan-derivative group were obtained in the following: speed of epithelialisation; leveling of the margins; degree of maceration; pain intensity and frequency.
                Hyalofill-F plus compression bandaging resulted in an earlier and greater decrease in ulcer area compared with non-adherent gauze plus compression bandaging, therapy supporting its use in the treatment of chronic venous ulcers. To assess the effect of different dressings on venous ulcer healing.
                A randomised clinical trial.
                Patients were randomised to treatment with one of three dressings: a zinc oxide impregnated bandage, a zinc oxide impregnated stockingette, or an alginate dressing. All patients were treated as outpatients and had compression bandaging with two minimal stretch bandages (Elastocrepe) and a stockingette (Tubigrip) to keep the bandages in place.
                One hundred and thirteen patients (133 ulcerated limbs) with chronic ulceration of the leg due to venous disease alone, and attending Fremantle Hospital Leg Ulcer Clinic, Western Australia were entered into the study. Healing was measured as complete healing of the ulcerated limb or failure of the limb to heal within 9 months.
                There was no significant difference between the three groups in ulcer size, duration, and other parameters compared. Healing was affected significantly by ulcer size and which leg was ulcerated. There was significantly faster healing with the paste bandage.
                The use of a paste bandage significantly improved the healing of chronic venous ulcers when used in combination with compression bandaging, and compared to an alginate dressing and a zinc oxide impregnated stockingette. To compare the effect on the microcirculation in venous leg ulcers (VLUs) of two treatment regimens that promote a moist wound environment versus paraffin gauze. The hypothesis is that moist wound dressings are more likely to stimulate the microcirculation and therefore angiogenesis.
                Patients with non-healing VLUs were randomised to receive either a foam dressing (Suprasorb P), a collagen dressing (Suprasorb C) plus the foam dressing, or paraffin gauze (control). All patients wore short-stretch high compression bandages. Parameters used to measure the effects of the treatments on the microcirculation were: TcPO2 measurements, video laser Doppler measurements and the number of capillaries in the wound bed. The progression towards healing was measured by the reduction in ulcer area and formation of granulation tissue. The treatment period was four weeks.
                Significant increases in TcPO2 values were reported between baseline and week 4 for patients receiving the foam dressing only or the collagen plus foam dressing combination (p<0.008 versus p<0.003 respectively). There was also a significant increase in the number of capillaries for the collagen plus foam treatment only (p<0.002).
                This pilot study suggests that a moist wound environment stimulates perfusion of blood and oxygen to the wound tissue, thereby promoting angiogenesis. The collagen and foam dressing combination demonstrated superior results to the control and the foam dressing only. Monitoring the microcirculation may help to assess the effect of dressings on VLU healing, although more research is needed.
                This pilot study was supported by a limited grant from Lohmann & Rauscher GmbH, Germany. To compare the performance of two compression systems, (multilayer elastic [Profore], Smith and Nephew) and (short stretch [Comprilan], Beiersdorf), in the treatment of venous leg ulcers in a randomised controlled trial.
                Eighty-nine patients with venous leg ulcers were randomised to receive treatment with Profore (44 patients) or short-stretch (45 patients) compression bandages. Allevyn (Smith and Nephew) was used as the wound contact layer under both systems.
                Patients treated with Profore healed significantly faster than those treated with short stretch (p = 0.03) and were 2.9 times more likely to heal at any given time during the study period. Younger wounds healed significantly faster than older wounds (p = 0.01).
                Patients treated with Profore healed faster than those treated with short-stretch bandages. In addition, treatment costs are lower with Profore. In this trial the average cost per patient was [symbol: see text] 1345 (short stretch) and [symbol: see text] 587 (Profore). Venous ulceration is a major problem, particularly in the elderly population. It causes stress to the patient and treatment can be time-consuming. Compression therapy is considered to be the most appropriate non-invasive treatment of venous ulcers. It is generally accepted that composite bandage systems are most efficacious using a long-stretch or short-stretch bandage system. The study reported has compared a long-stretch bandage (Setopress) with a short-stretch bandage (Elastocrepe) over a 16-week period in the treatment of patients with venous ulceration. The trial was a prospective, randomized, observer-blind, parallel group study. Thirty-two patients (male and female) with a total of 39 ulcers completed the trial. After 15 weeks, 11 of 19 ulcers treated with the long-stretch bandage and 7 of 20 ulcers treated with the short-stretch bandage had healed. The differences were not statistically significant. After 15 weeks, the ulcer healing rate for the long-stretch bandage was 58% compared with 35% for the short-stretch bandage. The combined proportion of ulcers healed or improved was statistically significantly greater in the long-stretch bandage group. A randomized controlled study was performed in 34 patients with venous leg ulcers. No difference was found in the healing rate between a new hydrocolloid dressing plus compression, and a double layer bandage, consisting of an inner paste bandage (i.e. a stocking impregnated with zinc oxide paste) and an outer elastic bandage. The parameters chosen for objective evaluation were stereophotogrammetric measurement of ulcer area and volume, and bacterial counts. To test the safety, efficacy, and immunological impact of a cultured allogeneic human skin equivalent (HSE) in the treatment of venous ulcers.
                Prospective, randomized study.
                Multicenter study in the outpatient setting.
                Each patient with a venous ulcer received either compression therapy alone or compression therapy and treatment with HSE. The patients were evaluated for HSE safety, complete (100%) ulcer healing, time to wound closure, wound recurrence, and immune response to the HSE.
                The study was completed as planned in 293 randomized patients.
                Treatment with HSE was more effective than compression therapy in the percentage of patients healed by 6 months (63% vs 49%; P=.02, Fisher exact test, 2-tailed) and the median time to complete wound closure (61 days vs 181 days; P=.003, log-rank test). Treatment with HSE was superior to compression therapy in healing larger (> 1000 mm2; P=.02) and deeper ulcers (P=.003) and ulcers of more than 6 months' duration (P=.001). Occurrence of adverse events was similar in both groups. No symptoms or signs of rejection occurred in response to treatment with HSE, and no HSE-specific immune responses were detected in vitro to bovine collagen or to alloantigens expressed on keratinocytes or fibroblasts.
                Treatment with HSE healed venous ulcers more rapidly and in more patients than compression therapy alone. There was no clinical or laboratory evidence of rejection or sensitization in response to HSE application. These data suggest that HSE represents a significant advance in the treatment of venous ulcers, particularly those that are difficult to heal. The aim of this paper was to describe the impact of the sonotherapy and compression therapy on enhancement of healing venous leg ulcers after surgical treatment.
                Three comparative groups of patients--A, B and C were made at random from patients with venous leg ulcers, which had been earlier operated by modified Babcock' method. The 24 patients were included (in use of software Monte Carlo) to the group A, 25 patients to the group B and 24 patients to the group C (control group). The patients in all comparative groups were treated pharmacologically. Ulcerations at patients in group A were additionally treated in use of ultrasound. And ulcerations at patients in group B were additionally treated in use of compression therapy. The evaluated factors were to estimate the sonotherapy and compression therapy causes any changes of the surface, longest and widest dimensions, and volume of tissue defect. For all comparative groups calculated the Gilman parameter. The weekly speed of changes of surface and volume were estimated too.
                After therapy there was statistically significant decrease of whole surface and pus-covered and granulation area, longest and widest dimensions, and volume of ulcers in all groups while there was no statistically significant difference--except pus-covered areas--between the groups observed. Comparison in terms of pus-covered area indicated a significant difference between all groups, in favor groups A and B than C.
                There are no special reasons for application of ultrasound and compression therapy in enhancement of healing process--however the following results must be verified on bigger population and longer patient observation. The sonotherapy and compression therapy promote only decontamination process compared with control group. A four-layer bandaging system developed at Charing Cross Hospital has been found to be effective in healing chronic venous ulcers but is not available on the Drug Tariff. An alternative system was devised from bandages available on the Drug Tariff and a community-based randomised controlled trial was undertaken to compare the two systems. Twenty-nine patients with a total of 35 ulcerated legs were recruited. Equal numbers of ulcerated legs healed using the two compression systems. Nineteen ulcerated legs did not heal, of which six were withdrawn from the trial-two in the trial system and four in the Charing Cross system. Of the 13 remaining ulcerated legs, for which treatment was completed, the mean reduction in ulcer area was 34% with the trial system and 39% with the Charing Cross system. The change in ulcer area was not statistically significant. However, a much larger trial is required in order to demonstrate definitively that the two bandaging systems are equivalent. The aim of the study was to compare the efficacy of two types of compression bandage with different degrees of elasticity on healing of venous leg ulcers. Forty-three patients with venous leg ulcers were included and blindly randomized to treatment with one of the two types of bandage aiming at a sub-bandage pressure in the ankle area of 40 mmHg. Forty legs were evaluated. Healed ulcers after 12 months were observed in 71% of the long-stretch group and in 30% of the short-stretch group (p = 0.06). Using life-table analysis the predicted healing rate in the long-stretch group after 12 months was 81% and for the short-stretch group 31% (p = 0.03). The mean of relative ulcer areas at 12 months was 0.25 for the long-stretch group and 0.95 for the short-stretch group (p = 0.01). The present study appears to indicate a positive influence of the elasticity of a compression bandage applied with a sub-bandage pressure around 40 mmHg in the ankle area on venous ulcer healing. Leg ulcers caused by chronic venous insufficiency plague an estimated 500,000 Americans, but there have been few improvements in conservative treatment in this century, and Unna's boot continues to be a mainstay of therapy. A recent report suggests that Duoderm CGF dressing provides greater patient comfort and enhanced compliance, but Duoderm alone (without compression) resulted in slower healing compared with Unna's boot. We enrolled 30 patients (30 ulcers) in a clinical trial to compare Duoderm CGF plus compression (Coban wrap) to Unna's boot. No significant difference was observed between the two groups with respect to age, sex, initial ulcer area, ulcer duration, or extent of venous insufficiency by duplex scan. Eight of 16 ulcers (50%) in the Duoderm group healed completely versus 6 of 14 ulcers (43%) in the Unna's boot group (p = 0.18). Healing rates (square centimeters per week) correlated significantly with initial ulcer area and initial ulcer perimeter for both groups but best correlated with initial ulcer perimeter (r = 0.88 with Duoderm, p less than 0.0001; r = 0.80 with Unna's boot, p less than 0.002). After adjusting for differences in initial ulcer perimeter, healing rates were significantly faster for patients on Duoderm than patients on Unna's boot during the first 4 weeks of therapy (0.384 +/- 0.059 cm2/wk/cm perimeter for Duoderm versus 0.135 +/- 0.043 cm2/wk/cm perimeter for Unna's boot; p = 0.002). At 12 weeks patients on Duoderm again appeared to heal faster than those on Unna's boot, although the result did not reach statistical significance (0.049 +/- 0.007 cm2/wk/cm perimeter for Duoderm versus 0.020 +/- 0.017 for Unna's boot, p = 0.11).(ABSTRACT TRUNCATED AT 250 WORDS) In this article, we describe a randomised trial in which two established primary dressings - Comfeel (Coloplast, UK) and Granuflex improved formulation (Convatec, UK) - were compared to Cutinova foam (Beiersdorf Medical, UK) in the management of venous leg ulcers. Patients that met the study trial criteria were randomised to receive one of the three primary dressings. All ulcers were secondarily bandaged with Comprilan (Beiersdorf Medical, UK) short-stretch compression. The three dressings were compared in terms of their ability to promote ulcer healing (closure rate and healing rate) and reduce the prevalence and severity of ulcer-associated pain, over a 12-week period. The ease with which dressings could be used in a busy outpatient clinic setting was also considered. On enrollment, groups were well matched in terms of all of the patient and ulcer parameters studies. Six patients were withdrawn for reasons unrelated to study dressings or trial procedures. Following non-parametric analysis of the study data, the three dressings were found to be equally effective at promoting ulcer healing and alleviating ulcer-associated pain. Study personnel rated Cutinova Foam as easy, if not easier, to use than Comfeel or Granuflex. This study suggests that Cutinova Foam is as safe and effective as both Comfeel and Granuflex, in the treatment of venous leg ulcers.
Compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear to be more effective than those composed mainly of inelastic constituents. Two-component bandage systems appear to perform as well as the 4LB. Patients receiving the 4LB heal faster than those allocated the SSB. More patients heal on high-compression stocking systems than with the SSB. Further data are required before the difference between high-compression stockings and the 4LB can be established.