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Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs — CAMPSTIM  

Diabetic Foot Clinical Trial

Official title:
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, 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.

Clinical Trial Description

The CAMPSTIM trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate four separate CAMPs (Cellular, Acellular, Matrix-like Products), Revita®, Relese®, Cogenex®, and Enverse®. The study utilizes a unique modified platform trial to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06449638
Study type Interventional
Source StimLabs
Contact Kristy Breisinger
Phone 888-960-1343
Email kbreisinger@serenagroups.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date August 2026
View Details
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