NCT07449988

Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs

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 Venous Leg Ulcers

• Status: Not Yet 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 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 venous leg ulcers over 12 weeks using a modified platform trial design.

Detailed description

The CORDSTIM-VLU 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.

Conditions

• Venous Leg Ulcers
• Venous Leg Ulcers (VLUs)
• Venous Leg
• Leg Ulcers
• Leg Ulcers Venous

Interventions

Type	Name	Description
OTHER	Standard of Care (SOC)	Beginning at the screening visit, participants will receive weekly treatment of standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first
DEVICE	Corplex P	Participants will receive weekly applications of Corplex P/Allacor P/Theracor P and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
DEVICE	Theracor	Participants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

Timeline

• Start date: 2026-07-01
• Primary completion: 2029-07-01
• Completion: 2029-09-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Regulatory

• FDA-regulated device study