RecruitingNot ApplicableNCT06616844

IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers

Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.


Sponsor

ConvaTec Inc.

Enrollment

235 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called InnovaMatrix® AC for people with ulcer and wound heal. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInnovaMatrix® AC

SOC plus weekly application of the study device


Locations(21)

Limb Preservation Platform

Fresno, California, United States

Angel City Research

Los Angeles, California, United States

Clemente Clinical Research

Los Angeles, California, United States

Valiance Clinical Research

San Diego, California, United States

Center for Clinical Research

San Francisco, California, United States

Valiance Clinical Research

Tarzana, California, United States

ILD Research Center

Vista, California, United States

First Excellence Research Group

Doral, Florida, United States

White-Wilson Wound Care Center

Fort Walton Beach, Florida, United States

Dinamo Research and Diagnostic Center

Hialeah, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Sunshine Ankle and Foot Experts

Orlando, Florida, United States

Lenus Research and Medical Group, LLC

Sweetwater, Florida, United States

Indiana Foot & Ankle

Jasper, Indiana, United States

US-FAS

Hagerstown, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Northwell Health Comprehensive Wound Healing Center

New Hyde Park, New York, United States

US-FAS

Raleigh, North Carolina, United States

University of Pittsburgh Medical Center (UMPC)

McKeesport, Pennsylvania, United States

Innovative Medical Research of Texas

Houston, Texas, United States

New Dawn Wellness and Medical Research Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06616844


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