Amniotic tissue 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

This study is testing if different types of amniotic tissue treatments can help people with chronic diabetic foot ulcers heal better when combined with standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tides Medical (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Fresno, California and 8 other locations)
• Trial ID: NCT06681428 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and efficacy of various amniotic tissue allografts combined with standard care in treating chronic non-healing diabetic foot ulcers. Participants will receive either an amnion/chorion/amnion allograft, an amnion/chorion allograft, or an amnion/amnion allograft, compared to standard care alone over a 12-week treatment period. The study focuses on patients with diabetic foot ulcers that have persisted for more than four weeks and meet specific size and circulation criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic diabetic foot ulcers that meet specific size and duration criteria.

Not a fit: Patients with diabetic foot ulcers that are not chronic or do not meet the specified size and circulation requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic diabetic foot ulcers.

How similar studies have performed: Other studies have shown promise with similar amniotic tissue approaches, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

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.
8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

Exclusion Criteria:

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
8. Subjects with a previous diagnosis of HIV or Hepatitis C
9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
11. Subject is pregnant or breast-feeding
12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
14. Presence of acute Charcot Neuroarthropathy to the affected limb
15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Where this trial is running

Fresno, California and 8 other locations

• Limb Preservation Platform Inc — Fresno, California, United States (Recruiting)
• Angel City Research — Los Angeles, California, United States (Recruiting)
• Clemente Clinical Research — Los Angeles, California, United States (Recruiting)
• ILD Research Center — Vista, California, United States (Recruiting)
• Clever Medical Research — Miami, Florida, United States (Recruiting)
• Foot and Ankle Specialists of the Mid-Atlantic — Raleigh, North Carolina, United States (Recruiting)
• Lower Extremity Institute of Research and Therapy — Boardman, Ohio, United States (Recruiting)
• Brock Liden DPM — Circleville, Ohio, United States (Recruiting)
• Foot and Ankle Specialists of the Mid-Atlantic — Salem, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Frank Burrows III, MBA, EMT, BCMAS, CWCA

Conditions Diabetic Foot Ulcer; Chronic Foot Ulcers; Amnion; Chorion; Amnion Amnion Graft; Amnion Chorion Amnion Grafts; Amnion Chorion Graft; Diabetes Mellitus