Use of GBT013, a Collagen-Based Dressing, for the Healing of Diabetic Foot Ulcers

Abstract

The number of people with diabetes is expected to reach 592 million in the year 2035. Diabetic foot lesions are responsible for more hospitalizations than any other complication of diabetes. The aims of this study were to examine for the first time a new biocompatible and biodegradable tridimensional collagen-based matrix, GBT013, in humans for diabetic foot ulcer wound healing and to evaluate its ease of use to better define a protocol for a future clinical trial. Seven adult patients with a diabetic foot ulcer of grade 1A to 3D (University of Texas Diabetic Wound Classification) were treated using GBT013, a new collagen-based advance dressing and were monitored in two specialized foot care units for a maximum of 9 weeks. Five of seven wounds achieved complete healing in 4 to 7 weeks. Nonhealed ulcers showed a significant reduction of the wound surface (>44%). GBT013 was well tolerated and displayed positive wound healing outcomes as a new treatment strategy of chronic foot ulcers in diabetic patients.