RecruitingNot ApplicableNCT06681428

Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers


Sponsor

Tides Medical

Enrollment

240 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares different types of amniotic tissue treatments (derived from the placenta) for healing chronic diabetic foot ulcers — open sores on the feet in people with diabetes that have not healed with standard care. **You may be eligible if...** - You are at least 18 years old - You have a diabetic foot ulcer that is not infected and has been present for more than 4 weeks but less than 1 year - The ulcer is at least 1 cm² and no larger than 25 cm² - The ulcer is a mild Grade 1 wound that extends through the skin but not deep into tissue **You may NOT be eligible if...** - You have a severely infected foot ulcer or very deep wound (Grade 2 or higher) - You have poor circulation in your legs (ankle-brachial index below threshold) - You have uncontrolled blood sugar levels or other serious health conditions - You are currently on dialysis or have kidney failure Talk to your doctor to see if this trial is right for you.

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

OTHERAllograft

Placental-based Allografts


Locations(9)

Limb Preservation Platform Inc

Fresno, California, United States

Angel City Research

Los Angeles, California, United States

Clemente Clinical Research

Los Angeles, California, United States

ILD Research Center

Vista, California, United States

Clever Medical Research

Miami, Florida, United States

Foot and Ankle Specialists of the Mid-Atlantic

Raleigh, North Carolina, United States

Lower Extremity Institute of Research and Therapy

Boardman, Ohio, United States

Brock Liden DPM

Circleville, Ohio, United States

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06681428


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