Clinical Efficacy of Type I Collagen Skin Substitutes Versus Human Amnion/Chorion in Treating Diabetic Foot Ulcers Using 55 Patient Randomized Controlled Independent Two Trials, One in India and the Other in the USA
Authors: Gunasekaran Subramanian 
Published: January 2025

Abstract
The purpose of this study is to compare whether the results of two separate studies simulates each other. As one would expect, the results are duplicative of each other that’s what we are planning to discuss in this research article. In a nutshell, the first study was conducted by Professional Education & Research Institute (PERI) at 9825 Kenwood Road, Suite 100, Blue Ash, OH 45242, USA which was managed by prestigious Dr. Charles M. Zelen, DPM who has over 20 years of clinical, academic, and industry experience in extremities, wound care, and biologic development programs. Over 22 Clinical Study publications have been published in reputed peer-reviewed journals. Another similar study was conducted by a distinguished plastic surgeon with immense experience in conducting randomized controlled clinical studies by name Dr. Naveen Narayan, MS, MCh (Plastic Surgery) at Adichunchanagiri Institute of Medical Sciences (AIMS), B G Nagara, Karnataka, India. To add to his credentials, he has 57 Clinical Study publications in respected journals with peer review. Both studies were registered on clinicaltrials.gov where one study was enrolled with 28 patients (NCT06470087) and the other study had a total no. of 27 patients (NCT06557122). It was intended to enroll 28 patients for each study. However, in the USA study, the Contact Research Organization (CRO) was able to recruit only 27 patients for the study in order to start the study on time. The first study of 28 patients were randomized into 2 groups of 14 patients each. The other study randomized into 2 groups of 12 patients each with exclusion of 3 patients who were rejected for the study due to their non-compliance with the approved protocol. Among the tested skin substitutes, one group consisted of standard of care (SOC) with High-Purity Type I Collagen-based Skin Substitute (HPTC) and the other group is the standard of care (SOC) with Dehydrated Human Amnion/Chorion Membrane (dHACM) in the treatment of Diabetic Foot Ulcers (DFUs). Each group was followed for 4 weeks of treatment as described in the methods section. The wound healing outcomes were evaluated on days 7, 10, 14, 17, 21, and 28. Both the study results were compared. The results from both India (AIMS) and the USA (PERI) studies showed that the HPTC group achieved significantly better healing outcomes compared to the dHACM group. Over the 28-day study period, HPTC demonstrated a healing recovery rate of 62%, while dHACM showed a recovery rate of 38%. These findings highlight that HPTC not only facilitated faster healing but also more complete wound closure, suggesting it as a potentially more effective treatment for managing chronic diabetic foot ulcers and reducing the risk of long-term complications. Even though they were conducted independently and separated continents apart, the clinical outcomes for both the studies were statistically significant proving the clinical efficacy of High-Purity Type I Collagen-based Skin Substitute (HPTC) was much higher than the other group, Dehydrated Human Amnion/Chorion Membrane (dHACM).