Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
Recruiting
N/A
Interventional Study
Diabetic Foot Ulcer
Diabetic Foot
Foot Ulcer Due to Type 2 Diabetes Mellitus
Foot Ulcer, Diabetic
Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 170 (estimated)
- Sponsor
- MiMedx Group, Inc. · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. At least 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. 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.
4. The target ulcer must have be…
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