A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Recruiting Phase 4 Interventional Study
Diabetic Foot Ulcer Foot Ulcer Chronic DFU Ulcer Foot Venous Leg Ulcer (VLU) Venous Leg Ulcer Venous Ulcer Leg Ulcers 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
50 (estimated)
Sponsor
BioLab Holdings · Industry
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About This Trial

The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care 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. * If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study. * The poten…
Contacts

Bennett Sarver

1-833-865-6300

info@serenagroups.com

CONTACT

Thomas Serena, MD

1-833-865-6300

Info@serenagroups.com

CONTACT