A Phase 4 Multicenter Study Testing a Single-Layer Placental-Based Graft Plus Standard Care for Treating Nonhealing Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of a single layer placental-based allograft combined with standard care for treating nonhealing diabetic foot ulcers. This controlled clinical trial follows a rescue design where patients who do not heal during a previous trial CAMPX and were treated only with standard care can enroll to receive the new study product. Participants must meet specific medical criteria related to cellular and matrix-like products as defined by Medicare guidelines. The intervention involves applying the single-layer amniotic membrane product called XWRAP alongside standard care for up to 12 weeks. Patients entering this rescue trial previously failed to heal their ulcers under standard care alone in the CAMPX trial. This study evaluates wound closure and related healing outcomes over this 12-week period. Participants will attend weekly study visits for up to 12 weeks during which researchers will assess wound closure, time to closure, wound size reduction, adverse events, and quality of life related to the wound. Several scales measuring wound impact and pain will also be used. Safety and wound healing progress will be closely monitored throughout the study duration.

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers