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

Recruiting N/A Interventional Study
Diabetic Foot Ulcer (DFU) Ulcer Foot Diabetic Foot 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
272 (estimated)
Sponsor
StimLabs · Industry
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About This Trial

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.

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 enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device. 4. The target ulcer m…
Contacts

Kristy Breisinger

888-960-1343

kbreisinger@serenagroups.com

CONTACT

Thomas Serena, MD

814-688-4000

serena@serenagroups.com

CONTACT