Closing chronic diabetic foot ulcers using standard wound care with or without an amnion-intermediate-chorion placental graft

A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

This trial will test whether adding a dehydrated human placental tissue product (AIC) to standard wound care helps close persistent diabetic foot ulcers in adults with type 1 or 2 diabetes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cellution Biologics (Industry-sponsored)
• Drugs / interventions: chemotherapy, Prednisone
• Locations: 8 sites (Santa Rosa, California and 7 other locations)
• Trial ID: NCT07014176 on ClinicalTrials.gov

What this trial studies

Adults with nonhealing diabetic foot ulcers who meet size, duration, and vascular criteria are enrolled and receive either standard of care (wound debridement, dressings, offloading) alone or standard of care plus applications of an amnion-intermediate-chorion (AIC) dehydrated placental tissue product. Wounds are measured post-debridement and treated over a defined follow-up period to determine complete ulcer closure. Key eligibility includes ulcers present at least four weeks, surface area 0.7–20.0 cm2, Wagner grade 1–2, and adequate limb perfusion. The primary outcome is the rate of complete wound closure comparing the two treatment approaches.

Who should consider this trial

Good fit: Ideal candidates are adults with type 1 or 2 diabetes who have a nonhealing foot ulcer present for at least four weeks, 0.7–20.0 cm2 in size, Wagner grade 1–2, no exposed tendon or bone, and adequate limb perfusion with HbA1c under 12%.

Not a fit: Patients with exposed bone or tendon, poor limb perfusion, ulcers outside the specified size or depth range, active severe infection or uncontrolled diabetes (HbA1c ≥12%), or inability to attend study visits are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding AIC to standard care could increase the proportion of diabetic foot ulcers that fully close and potentially lower infection and amputation risk.

How similar studies have performed: Prior trials and real-world reports of amniotic/placental-derived wound products have shown improved healing rates in many patients, though results vary by product and patient population.

Eligibility criteria

Inclusion Criteria:

Subjects will be eligible to participate in the study if the following conditions exist:

Inclusion Criteria:

1. 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
5. Target ulcer present for minimum of 4 weeks prior to screening visit.
6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
7. Target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
8. Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:

   1. ABI ≥ 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 40 mmHg;
   4. PVR: biphasic or triphasic.
9. Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
10. Subject must consent to using the prescribed off-loading method for the duration of the study.
11. Subject must agree to attend study visits required by the protocol.
12. Subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

Subjects will be excluded from participation in the study if any of the following conditions exist:

1. Known life expectancy of \< 6 months.
2. Target ulcer is not secondary to diabetes.
3. Target ulcer is infected or there is cellulitis in the surrounding skin.
4. Evidence of osteomyelitis complicating the target ulcer.
5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.
6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. Topical application of steroids to the ulcer surface within one month of screening.
8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
9. Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
10. Mini Nutritional Assessment (MNA) score of less than 17.
11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
13. Currently require dialysis or planning to start dialysis.
14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

Where this trial is running

Santa Rosa, California and 7 other locations

• 005 — Santa Rosa, California, United States (Recruiting)
• 001 — Jacksonville, Florida, United States (Recruiting)
• 003 — Chicago, Illinois, United States (Recruiting)
• 007 — Mooresville, North Carolina, United States (Recruiting)
• 002 — Rocky Mount, North Carolina, United States (Recruiting)
• 008 — Allentown, Pennsylvania, United States (Recruiting)
• 004 — Philadelphia, Pennsylvania, United States (Recruiting)
• 006 — Hilton Head Island, South Carolina, United States (Active_not_recruiting)

Study contacts

• Study coordinator: Bryanna Finstein, BS

Conditions Diabetic Foot Ulcer; DFU; Diabetic Ulcer; Foot Wound; Placenta