Multi-center, Randomized Controlled Clinical Investigation Evaluating a Unique Advance Wound Care Matrix versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Geistlich Derma-Gide® is an advanced wound care device, which is intended to be used for dermal regeneration. Geistlich Derma-Gide® features a bilayer structure. This structure has a smooth texture with appropriate pull out strength properties to allow suturing. The second lower layer consists of a thick, porous spongeous scaffold. Geistlich Derma-Gide® provides a favorable environment for cell migration. Case studies involving the treatment of chronic diabetic foot ulcers (DFUs) with Geistlich Derma-Gide® suggest that when used supplementary to the accepted routine procedures which are part of standard of care improved healing trajectories result. The purpose of this clinical investigation is to assess safety and performance of Geistlich Derma-Gide® and to collect patient outcome data on the treatment of diabetic foot ulcers (DFU) vs Standard of Care (SOC). This clinical investigation is a prospective, multi-center, parallel-group, randomized controlled trial (RCT). Following initial enrollment, subjects will undergo a screening phase. Eligible subjects will then undergo a treatment phase involving weekly evaluations and after 13 weeks, subjects will complete the study. The primary hypothesis is that the proportion of wounds healed at 12 weeks will be higher when treated with Geistlich Derma-Gide® than when treated with SOC procedures.