Abstract / Summary
Diabetic foot ulcers (DFUs) are a devastating complication of diabetes that markedly affects quality of life and generates significant socioeconomic and healthcare burdens. When DFUs fail to respond to standard of care (SOC), advanced therapies including Cellular, Acellular and Matrix-like Products (CAMPs) are often employed. A novel composite CAMP comprising ovine forestomach matrix and high molecular weight hyaluronic acid, termed 'OFM-HA' has been developed for the treatment of chronic wounds and evaluated in a prospective multi-centre controlled trial. For this trial, 143 subjects were randomized to receive OFM-HA plus SOC or SOC alone for the treatment of chronic full thickness wounds of the foot in people with diabetes meeting prespecified eligibility criteria. The primary endpoint was the proportion of wounds healed by 12 weeks. Secondary endpoints included healing time, percentage area reduction, adverse events and changes in pain and quality of life. For the modified intent-to-treat population, 46% (31/68) of the OFM-HA plus SOC group healed by 12 weeks compared to 24% (17/72) in the SOC alone group (p = 0.008). Kaplan-Meier analysis favoured OFM-HA plus SOC over 12 weeks (log-rank p = 0.023). No unexpected safety-related occurrences were observed. OFM-HA plus SOC increased 12-week closure in this selected population. Interpretation is limited by post-randomization exclusions, differential withdrawal and an adjusted comparison close to the significance threshold (p = 0.045).