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.
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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…
Contacts

Brittany Bonafide

888-960-1343

bbonafide@serenagroups.com

CONTACT

Thomas Serena, MD

tserena@serenagroups.com

CONTACT