Randomized Study of EDX110 Dressing Plus Standard Care Versus Standard Care Alone for Healing Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating whether adding the EDX110 dressing system to the usual treatment can improve healing of diabetic foot ulcers. This is a prospective, multi-center, observer-blinded randomized controlled trial comparing EDX110 plus standard care to standard care alone in adults with diabetic foot ulcers. The study is sponsored by ConvaTec Inc. and aims to assess wound closure and healing progress over several weeks. Participants will be randomly assigned to one of two groups one receiving the EDX110 wound dressing system along with standard care and the other receiving only the traditional standard of care for diabetic foot ulcers. The EDX110 device includes two layers designed to generate nitric oxide on the wound, manage moisture, and help with wound cleaning. Treatment duration and follow-up extend up to 24 weeks to monitor healing outcomes. During the study, participants will undergo regular assessments to measure wound closure at 16 weeks as the primary outcome, with additional evaluations at 4, 16, and 24 weeks to track wound size reduction and healing time. Researchers will monitor the wounds and overall health throughout the trial, ensuring adherence to study procedures and safety. Total participation duration varies but includes follow-up visits to evaluate the wound healing progress and safety of the treatments.

EDX110 Randomized Control Trial for Treatment of DFUs