RecruitingNot Applicable

Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs

United States170 participantsStarted 2024-08-27

Plain-language summary

This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 18 years of age or older.
. Diagnosis of type 1 or 2 Diabetes mellitus.
. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 measured post debridement.
. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;

Exclusion criteria

. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of target ulcers achieving wound closure

Timeframe: 1 - 12 weeks

Trial details

NCT IDNCT06600724

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Brittany Bonafide

888-960-1343 bbonafide@serenagroups.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials