PMC6902838_01
Case 1 (a) 77 year old patient with an arterial venous ulcer that had not shown improvement for 7 months before treatment was scheduled for amputation. (b) After 3 weeks of treatment with OTR4120, the wound size had been greatly reduced and showed no signs of inflammation. Amputation was avoided and the patient no longer required painkillers.
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F1
The first patient was a 77 year old man with an arterial venous ulcer that had not improved for the last 7 months (Fig. 1A). At 3 weeks, the patient's wound had been greatly reduced and no longer showed signs of inflammation (Fig. 1B).
PMC6902838_02
Case 2 (a) 65 year old patient with an ischemic, diabetic, neuropathic foot ulcer that had not shown improvement for 6 months before treatment, presenting with a necrotic lesion (black arrows) on the ligament and no granulation tissue (b) After 2 weeks of treatment with OTR4120, the necrotic zone diminished and granulation tissue formed, allowing the patient to avoid amputation and to be eligible for a skin graft.
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F2
The second patient was a 65 year old man with an ischemic and diabetic (and neuropathic) ulcer presenting necrotic tissue which increased in size daily, despite intensive conventional care, which aimed to prevent further development of necrosis (Fig. 2A). Within a few days, the size of necrotic tissue was reduced and in 2 weeks granulation tissue had covered most of the wound, allowing the option for a skin graft to help accelerate wound closure. (Fig. 2B).
Ulcer size reduction during OTR4120 treatment. Changes in ulcer size during OTR4120 treatment per patient and treatment week. Mean ulcer surface area at each time point was divided by ulcer surface area at baseline and is shown for each patient and treatment week. The horizontal bars represent the average for each time point. *P <= 0.05, ** p <= 0.01.
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F3
As seen in Figure 3, the mean ulcer area for all patients decreased over the course of OTR4120 treatment. Ulcer surface area reduction was significant as soon as week 2 versus baseline (primary endpoint; 19%, p < 0.02) and even more significant at 4 weeks versus baseline (35%, p < 0.001; Fig. 3).
Evolution of analgesic consumption over the treatment period. (a) Evolution of the analgesic class over the treatment period. The majority of patients at T0 were taking class 3 (striped bars) analgesics at T0, which decreased over the course of the treatment. (b) Overall analgesic consumption decreased over time, calculated by the sum of the patients of the analgesic class multiplied by the corresponding arbitrary unit (none = 0 AU, class 1 = 1 AU, class 2 = 2AU, class 3 = 3AU). AU, arbitrary unit.
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F4
Analgesic use is shown in Figure 4. 1 arbitrary unit (AU) was assigned to step 1 analgesics, 2 AU were assigned to step 2 analgesics, and 3 AU were assigned to to step 3 analgesics. These included 4 who were taking class 3 analgesics and 7 who were taking class 2 analgesics (Fig. 4A).The AU number decreased from 27 at the beginning of the treatment to 14 at 4 weeks (51.8%) and 11 (60%) at 8 weeks (Fig. 4B).