NCT06449638

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: StimLabs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer (DFU)
• Ulcer Foot
• Diabetic Foot
• Foot Ulcer

Interventions

Type	Name	Description
OTHER	Standard of Care	Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Revita	Participants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Relese	Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Cogenex	Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Enverse	Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Timeline

• Start date: 2024-07-16
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-06-10
• Last updated: 2026-03-02

Locations

5 sites across 1 country: United States