Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers

Recruiting Phase 4 Interventional Study
Diabetic Foot DFU Diabetic Foot Ulcer Foot Ulcer, Diabetic Ulcer Foot Venous Leg Ulcer Leg Ulcer Leg Ulcers Venous Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
650 (estimated)
Sponsor
BioLab Holdings · Industry
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About This Trial

The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of…
Contacts

Bennett Sarver

888-960-1343

bsarver@serenagroups.com

CONTACT

Thomas Serena

814-688-4000

tserena@serenagroups.com

CONTACT