A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) are a prevalent and costly complication of diabetes, contributing significantly to patient morbidity and healthcare burdens. This randomized controlled trial aimed to compare the safety and efficacy of high-purity type-I collagen-based skin substitute (HPTC) and dehydrated human amnion/chorion membrane (dHACM) in the treatment of DFUs. The study enrolled patients from the Adichunchanagiri Institute of Medical Sciences (B.G. Nagara, KA, IND) and followed them for a four-week treatment period, with wound healing outcomes evaluated on days seven, 10, 14, 17, 21, and 28. A total of 28 patients were randomized to receive standard care with either HPTC or dHACM. The results demonstrated that the HPTC group achieved significantly better healing outcomes, with 85.71% of patients exhibiting ≥50% wound size reduction at four weeks compared to 50% of patients in the dHACM group. Furthermore, complete wound closure was observed in 10 patients treated with HPTC compared to seven in the dHACM group. The mean reduction in wound size was 86.48% in the HPTC group, compared to 77.70% in the dHACM group. The superior healing effect of HPTC is attributed to its composition, which enhances cellular attachment and accelerates tissue regeneration. In conclusion, HPTC demonstrated faster and more complete healing of DFUs compared to dHACM, indicating its potential as a more effective treatment option for managing chronic DFUs and reducing the risk of long-term complications.