Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. A comparative study between total contact casting and conventional dressings in the non-surgical management of diabetic plantar foot ulcers. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Applied felted foam for plantar pressure relief is an efficient therapy in neuropathic diabetic foot ulcers. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Wound healing: total contact cast vs. custom-made temporary footwear for patients with diabetic foot ulceration. [Prevention of heel pressure sores with a foam body-support device. A randomized controlled trial in a medical intensive care unit]. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized clinical trial.
nan To evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer.
                Forty-five adult diabetic patients with nonischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with a nonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
                A total of 48 patients were screened; however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts. There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study. Ulcer surface decreased from 1.41 to 0.21 cm(2) (P < 0.001) in the TCC group and from 2.18 to 0.45 cm(2) (P < 0.001) in the Stabil-D group, with no significant differences between groups (P = 0.722). Seventeen patients (73.9%) in the TCC group and 16 patients (72.7%) in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 +/- 3.1 and 39.7 +/- 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708).
                The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers. To evaluate and compare the rate of reduction of the surface area of neuropathic plantar ulcers in diabetic patients treated with nonremovable rigidity-differentiated fiberglass off-bearing casts or a cloth shoe with a rigid sole with unloading alkaform insoles. The secondary aim was to evaluate the side effects and degree of patient acceptance of treatment.
                Fifty diabetic patients with neuropathic plantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Of the 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unloading alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bearing fiberglass cast (cast group). All patients in both study groups returned to the clinic for weekly control visits. Their ulcers were treated with a standard dressing. Tracings of the ulcer area using a transparent dressing were performed on the day of entry to the study and after 30 days of treatment. The presence of new ulcerations caused by the use of the pressure-relief apparatus was recorded. Patient acceptance of the treatment was measured using a visual analog scale.
                At the end of the treatment period, an 8.3% increase of the ulcer area was observed in two patients in the shoe group, whereas in the cast group, no patient presented an increase. The reduction of the ulcer area was statistically more rapid in the cast group (Mann-Whitney test, P = 0.0004). Furthermore, the number of ulcers completely healed at the 30-day time point was 13 (50%) in the cast group and 5 (20.8%) in the shoe group (P = 0.03). In both groups, no side effects were recorded. The average score +/- SD of patient acceptance was 91.15 +/- 9.9 in the shoe group and 88.33 +/- 17.3 (NS) in the cast group.
                Our study has shown a significant difference in the speed of the reduction of neuropathic plantar ulcers treated with a fiberglass cast compared with a specialized cloth shoe. The use of fiberglass material with variable rigidity has also shown two important results: the elimination of side effects including ulcers caused by the cast, and high patient acceptance. These data show that the use of off-bearing casts made with fiberglass bandages of variable rigidity is the elective treatment of neuropathic plantar ulcers. Of all non-traumatic amputations 50% occur in Diabetics, mostly as a final outcome of foot ulcers. A major biomechanical factor in the causation of foot ulcers in persons with diabetes mellitus is elevated peak plantar pressure. Offloading the ulcer area in the form of equalisation of pressure across the plantar surface can accelerate healing of the ulcer. Total contact casting is one such method of offloading, and this study attempts to investigate the advantages of the above method as compared to conventional dressings in the physiatric management of the depth--ischaemia grades 1A, 1B, 2A, 2B neuropathic plantar ulcers in a diabetic patient. The outcome measure was the time taken for complete resolution of the ulcers. Of the 29 patients in Category A treated with total contact casting involving a total of 39 foot ulcers, 36 healed, which was statistically significant (p < 0.05) as compared to 25 out of the 33 ulcers healing in Category B consisting of 26 patients treated by conventional dressings alone. Total contact casting is an effective, rapid, economical, ambulatory and outpatient--based method for the treatment of diabetic foot ulcers. This study was designed to test the safety, effectiveness, and costs of off-loading with a novel, off-the-shelf irremovable device in the management of diabetic foot ulceration (DFU).
                We prospectively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic outpatients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up, number and severity of adverse events, healing time, costs and applicability of the device, and patients' satisfaction between those randomly assigned to total contact casting (TCC; group A) or to the Optima Diab walker (group B). Deep or infected ulcers were excluded.
                No difference between groups A and B was observed in healing rates at 12 weeks (95 vs. 85%), healing time (6.5 +/- 4.4 vs. 6.7 +/- 3.4 weeks), and number of adverse events (six versus four). Treatment was significantly less expensive in group B, which showed a mean reduction of costs of 78% compared with group A (P < 0.001). Practicability was more favorable in group B, with a reduction of 77 and 58% of the time required for application and removal of the devices, respectively (P < 0.001). Patients' satisfaction with the treatment was higher in group B (P < 0.01).
                The Optima Diab walker is as safe and effective as TCC in the management of DFU, but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot. The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers.
                In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at </=12 weeks, healing rates, complication rates, cast placement/removal times, and costs.
                The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 80 and 74%, respectively (94 and 93%, respectively, when patients who were lost to follow-up were excluded). Survival analysis (healing rates) was statistically equivalent in the two groups, as were complication rates, but with a trend toward benefit in the iTCC group. The iTCC took significantly less time to place and remove than the TCC with 39% and 36% reductions, respectively. There was also an overall lower cost associated with the use of the iTCC compared with the TCC.
                The iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers. The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations.
                We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing.
                An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02).
                Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds. The application of felted foam is a promising method for plantar pressure reduction in the ulcer region of neuropathic diabetic foot ulcers, but the knowledge of its impact on the wound healing and healing times in foot ulcers compared to conventional methods of pressure relief is sparse. The aim of this study was to assess the effects on the wound healing of felted foam dressings for plantar pressure reduction in the therapy of neuropathic foot ulcers. This prospective cohort study evaluates healing times and wound healing in 61 diabetic patients with neuropathic foot ulcerations. Ulcer healing was assessed by planimetric measurement of the wound area at beginning of the study and after 10 weeks and at least until wound healing. The patients were consecutively enrolled in the study, 27 patients were randomized to the felted foam therapy, and 34 patients were randomized to conventional therapy. In the felted foam group, the initial average wound area was 110.8 +/- 14.4 mm 2 (mean +/- SE), and 2.1 +/- 0.5 mm 2 after ten weeks (p < 0.0001), with an average healing time of 79.6 (95%-CI 75-84) days. In the conventional therapy group, the initial average wound area was 119.2 +/- 13.8 mm 2, and 3.4 +/- 0.7 mm 2 after ten weeks (p < 0.0001). The average healing times was 83.2 (95%-CI 77-90) days. Both with respect to the wound healing process and the healing times, the felted foam technique appears to be as effective as conventional plantar ulcer treatment. We conclude that the felted foam technique is an useful alternative in the therapy of the neuropathic diabetic foot syndrome, especially in patients who are not able to avoid weight-bearing reliably. This study compared the treatment of total contact casting (TCC) with traditional dressing treatment (TDT) in the management of diabetic plantar ulcers. Forty patients with diabetes mellitus and a plantar ulcer but with no gross infection, osteomyelitis, or gangrene were randomly assigned to the TCC group (n = 21) or TDT group (n = 19). Age, sex, ratio of insulin-dependent diabetes mellitus to non-insulin-dependent diabetes mellitus, duration of diabetes mellitus, vascular status, size and duration of ulcer, and sensation were not significantly different between groups (P greater than .05). In the experimental group, TCC was applied on the initial visit, and subjects were instructed to limit ambulation to approximately 33% of their usual activity. Subjects in the control group were prescribed dressing changes and accommodative footwear and were instructed to avoid bearing weight on the involved extremity. Ulcers were considered healed if they showed complete skin closure with no drainage. Ulcers were considered not healed if they showed no decrease in size by 6 wk or if infection developed that required hospitalization. In the TCC group, 19 of 21 ulcers healed in 42 +/- 29 days; in the TDT group, 6 of 19 ulcers healed in 65 +/- 29 days. Significantly more ulcers healed (chi 2 = 12.4, P less than .05) and fewer infections developed (chi 2 = 4.1, P less than .05) in the TCC group. We conclude TCC is a successful method of treating diabetic plantar ulcers but requires careful application, close follow-up, and patient compliance with scheduled appointments to minimize complications. The objective of this study was to compare the effectiveness of irremovable total-contact casts (TCC) and custom-made temporary footwear (CTF) to heal neuropathic foot ulcerations in individuals with diabetes. In this prospective clinical trial, 43 patients with plantar ulcer Grade 1 or 2 (Wagner scale) were randomized to one of two off-loading modalities: TCC or CTF. Outcomes assessed were wound surface area reduction (cm2) and time to wound healing (days) at 2, 4, 8 and 16 weeks. To evaluate safety, possible side effects were recorded at each follow-up visit. The results showed no significant difference in wound surface area reduction (adjusted for baseline wound surface) at 2, 4, 8 or 16 weeks (adjusted mean difference 0.10 cm2; 95% CI -0.92-0.72 at 16 weeks). At 16 weeks, 12 patients had a completely healed ulcer, 6 per group. The median time to healing was shorter for the patients using a cast (52 vs. 90 days, p = 0.26). Five patients with TCC and two with CTF developed device-related complications. It was concluded that: (i) the rate of wound healing is not significantly different for patients treated with CTF or TCC. The difference in wound surface area was small and not significant at any time during follow-up; and (ii) the difference in healing time (38 days) may have attained statistical significance if the numbers in these sub-groups (2 x 6) had been higher. Since there appears to be little difference in effectiveness between both off-loading modalities, further investigation into the benefits of CTF is warranted. To assess in a prospective controlled study the efficacy and safety of a specific foam body-support device designed as to prevent heel pressure ulcers.
                A randomization table was used to allocate 70 patients into 2 groups. The control group was treated with our standard pressure sore prevention protocol (half-seated position, water-mattress and preventive massages 6 times a day); the experimental group was treated with the same standard protocol as well as with the foam body-support device being evaluated. Patients were included if their Waterlow score was >10, indicating a high risk of developing pressure ulcers and if they had no skin lesion on the heels. Foam devices, covered with jersey, were constructed for the legs and allowed the heels to be free of any contact with the bed; another foam block was arranged perpendicularly to the first, in contact with the soles, to prevent ankles from assuming an equinus position (to prevent a dropfoot condition). The principal criterion for efficacy was the number of irreversible skin lesions on the heel (that is, beyond the stage of blanching hyperemia, reversible after finger pressure); these lesions were assessed every day until the end of the study (up to 30 days).
                The number of irreversible heel pressure ulcers was lower in the experimental (3 patients, 8.6%) than in the control group (19 patients, 55.4%) (p<0.0001). Mean time without any pressure ulcer was higher in the experimental group (5.6 days, compared with 2.8 days, p=0.01). The groups did not differ in the number of pressure sores on the sacrum and leg.
                An anatomical foam body-support is effective in preventing heel pressure ulcers in patients on a medical intensive care unit and is well tolerated. To evaluate the utility of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers.
                Nineteen subjects with either insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (NIDDM) and foot ulcers were randomly assigned to the polymeric dressing or conventional wet-to-dry saline dressings. Subjects had foot ulcer site measurements performed every 3 weeks. The subjects using conventional therapy were allowed to cross over to polymeric dressing after 2 months.
                At the end of 2 months, in the patients using the polymeric dressing, ulcer size was reduced to 35 +/- 16% of baseline. The patients on conventional therapy had an ulcer size of 105 +/- 28% of baseline (P < 0.03, polymeric vs. conventional). Patients initially treated with wet-to-dry saline were crossed over into the polymeric membrane treatment and demonstrated a decrease to 35 +/- 11% of baseline size (p < 0.02) after an additional 2 months.
                The semipermeable polymeric membrane dressing is a useful therapeutic option for treating uncomplicated chronic diabetic foot ulcers. Limited ankle dorsiflexion has been implicated as a contributing factor to plantar ulceration of the forefoot in diabetes mellitus. The purpose of this study was to compare outcomes for patients with diabetes mellitus and a neuropathic plantar ulcer treated with a total-contact cast with and without an Achilles tendon lengthening. Our primary hypothesis was that the Achilles tendon lengthening would lead to a lower rate of ulcer recurrence. Methods: Sixty-four subjects were randomized into two treatment groups, immobilization in a total-contact cast alone or combined with percutaneous Achilles tendon lengthening, with measurements made before and after treatment, at the seven-month follow-up examination, and at the final follow-up evaluation (a mean [and standard deviation] of 2.1 +/- 0.7 years after initial healing). There were thirty-three subjects in the total-contact cast group and thirty-one subjects in the Achilles tendon lengthening group. There were no significant differences in age, body-mass index, or duration of diabetes between the groups. Outcome measures were time to healing of the ulcer, ulcer recurrence rate, range of dorsiflexion of the ankle, peak torque (strength) of the plantar flexor muscles, and peak plantar pressures on the forefoot.
                Twenty-nine (88%) of thirty-three ulcers in the total-contact cast group and all thirty ulcers (100%) in the Achilles tendon lengthening group healed after a mean duration (and standard deviation) of 41 +/- 28 days and 58 +/- 47 days, respectively (p > 0.05). (One patient in the Achilles tendon lengthening group died before treatment was completed.) In the first seven months of follow-up, sixteen (59%) of the twenty-seven patients in the total-contact cast group who were available for follow-up and four (15%) of the twenty-seven patients in the Achilles tendon lengthening group who were available for follow-up had an ulcer recurrence (p = 0.001). At the time of the two-year follow-up, twenty-one (81%) of the twenty-six patients in the total-contact cast group and ten (38%) of the twenty-six patients in the Achilles tendon lengthening group had ulcer recurrence (p = 0.002). Compared with the group treated with the total-contact cast, the group treated with Achilles tendon lengthening had increased dorsiflexion and it remained increased at seven months (p < 0.001). Plantar flexor peak torque also decreased after Achilles tendon lengthening (p < 0.004), but it returned to baseline after seven months. Peak plantar pressures on the forefoot during barefoot walking were reduced (p < 0.0002) following Achilles tendon lengthening yet returned to baseline values within seven months after treatment.
                All ulcers healed in the Achilles tendon lengthening group, and the risk for ulcer recurrence was 75% less at seven months and 52% less at two years than that in the total-contact cast group. Achilles tendon lengthening should be considered an effective strategy to reduce recurrence of neuropathic ulceration of the plantar aspect of the forefoot in patients with diabetes mellitus and limited ankle dorsiflexion (</=5 degrees ).
Non-removable, pressure-relieving casts are more effective in healing diabetes related plantar foot ulcers than removable casts, or dressings alone. Non-removable devices, when combined with Achilles tendon lengthening were more successful in one forefoot ulcer study than the use of a non-removable cast alone.