Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

Recruiting N/A Interventional Study
Pathologic Processes Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Disease Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetic Neuropathies Foot Diseases Diabetic Foot Foot Ulcer Diabetes Mellitus, Type 2 Ulcer Foot Ulcer Unhealed
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
177 (estimated)
Sponsor
C5 Biomedical · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria for DFU: 1. At least 18 years of age or older. 2. Must have diagnosis of type 1 or 2 Diabetes mellitus. 3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging devi…
Contacts

Bennett Rogers

888-960-1343

Brogers@serenagroups.com

CONTACT

Connie Chung, PhD

734-730-3058

Connie@c5biomedical.com

CONTACT