Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

Recruiting N/A Interventional Study
Diabetic Foot Ulcer Venous Leg Ulcer Ulcer Foot Leg Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
324 (estimated)
Sponsor
Stability Biologics · Industry
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About This Trial

This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridem…
Contacts

Bennett M Rogers

888-960-1343

brogers@serenagroups.com

CONTACT

Thomas Serena, MD

814-688-4000

serena@serenagroups.com

CONTACT