Comparing the Efficacy of a Unique Advanced Bioengineered Type-I Collagen-Based Skin Substitute Versus an Amnion Graft With Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers: A Randomized Clinical Trial.

Abstract

The increased cost and morbidity associated with diabetic foot ulcers (DFUs) place a substantial strain on the entire global healthcare system. In this trial, 24 subjects with a chronic DFU, Wagner grade 1 (University of Texas grade 1A), were treated with Standard of Care (SOC) therapy and randomized, one-half to receive advanced high-purity Type-I collagen-based skin substitute (HPTC; manufactured by Encoll Corp., Fremont, CA, USA), and the other half to receive a dehydrated human amnion/chorion membrane (dHACM) or viable cryopreserved human placental membrane (vCHPM). The primary study endpoint was percentage wound area reduction (PAR) over the five-week treatment period. Secondary endpoints included healing time, proportion of wounds closed, and mean number of graft applications. By four weeks post-randomization, the mean PAR for the HPTC group was 83.9 versus 71.3 for dHACM or vCHPM. By four weeks, 6/12 (50%) of wounds receiving HPTC healed, compared to 3/12 (25%) in the comparator group (dHACM or vCHPM). There were no adverse events reported in either group. The results of this study suggest that HPTC shows great promise in wound healing in people with DFUs, with the given limitations. We look forward to future studies that will confirm these encouraging results.