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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

A Multicenter, Prospective, Randomized Controlled Modified Platform 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.

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

Condition
Pathologic Processes
Intervention / Treatment

-

Contacts and Locations

Metairie

Poirot Podiatry, Metairie, Louisiana, United States, 70001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    C5 Biomedical,

    Thomas Serena, MD, PRINCIPAL_INVESTIGATOR, SerenaGroup, Inc.

    Study Record Dates

    2027-01-22