Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs
brief summary
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
detailed description
The CORDSTIM-DFU trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate two separate CAMPs (Cellular, Acellular, Matrix-like Products), Corplex P®/Allacor P™/Theracor P™ and Theracor™. The study utilizes a modified platform trial design to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.
official title
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Umbilical CORD-Based Skin Substitutes and Standard of Care Versus Standard of Care Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers