A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Description

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Conditions

Diabetic Foot Ulcer, Venous Leg Ulcer

Study Overview

Study Details

Study overview

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Multicenter, Prospective, Randomized, Controlled Platform Trial Assessing Clinical Utility of Cellular, Acellular and Matrix-like Products (CAMPs) and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers.

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Omaha

SerenaGroup Omaha Research Center, Omaha, Nebraska, United States, 68114

Jefferson Hills

SerenaGroup Research South, Jefferson Hills, Pennsylvania, United States, 15025

Kittanning

Armstrong County Memorial Hospital, Kittanning, Pennsylvania, United States, 16201

Monroeville

SerenaGroup Monroeville, Monroeville, Pennsylvania, United States, 15146

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 80 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Integra LifeSciences Corporation,

    Tomas Serena, MD, PRINCIPAL_INVESTIGATOR, SerenaGroup, Inc.

    Study Record Dates

    2026-08-31