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Diabetic foot ulcers (DFU), which can affect up to 15% of individuals with diabetes, remain a major unmet medical need. Left untreated, DFU seriously impact on quality of life and level of function. Conventional treatment is costly and often ineffective. In severe cases, patients with DFU may undergo painful amputations. IZN 6D4 is an impregnated hydrogel containing active pharmaceutical ingredients that have both wound-healing promoting and anti-inflammatory activities This is an observational human clinical trial study involving 15 patients treated with IZN 6D4. Subjects in the study had DFU which were categorized as being at stage 1A or greater using the University of Texas Health Science Center, San Antonio scale (UTHSC) grading system. Treatment lasted 21 days, and during the course of the study, patches were applied every 3-4 days. Response to therapy was measured by extent and depth of the lesion (wound grid and digital photography), qualitative assessment of wound healing (tissue granulation), and the rate of wound closure over the trial period. Results of the study showed that 40% of subjects had 75% closure of the wound and 27% had complete wound closure. Nearly all patients had evidence of active wound healing (e.g., presence of granulation tissue), and percent mean wound reduction for the entire study group was 67.7 ± 26.4%. Photo documentation of wound healing showed impressive differences between pre- and posttreatment appearances of diabetic ulcers in many of the patients studied. Based on the promising data from preclinical studies and the observational clinical trial provide strong justification for initiating a large-scale, longer duration clinical trial evaluating the efficacy of IZN 6D4 hydrogel in the treatment of patients with DFU.

A Pilot Study to Evaluate the Efficacy of IZN 6D4 for the Treatment of Diabetic Foot Ulcers