RecruitingDiabetic Foot Ulcer (DFU)Chronic Foot Ulcers

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

Eligible age

18+ yrs

Accepts

All genders

Locations

5 states

Healthy volunteers

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About this study

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.

Sponsor: Tides Medical

You may qualify if…

✓ Potential subjects are required to meet all of the following criteria for enrollment into the study.
✓ 1. At least 18 years old, inclusive.
✓ 2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
✓ 3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
✓ 4. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
✓ 5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
✓ 6. Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
✓ 7. The target ulcer has been offloaded for at least 14 days, prior to TV1.

You may not qualify if…

✕ Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
✕ 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
✕ 2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
✕ 3. Index ulcer is infected
✕ 4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
✕ 5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
✕ 6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
✕ 7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies

Where it's recruiting

California

Fresno · Los Angeles · Vista

Florida

Miami

North Carolina

Raleigh

Ohio

Boardman · Circleville

Virginia

Salem

Source: ClinicalTrials.gov · NCT06681428 · last updated 2025-02-10