Comparing Amnion Membrane Allograft and Standard Care for Diabetic Foot Ulcers

A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone

This study is testing whether a new amniotic membrane treatment can help heal diabetic foot ulcers better than a standard collagen dressing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Skye Biologics Holdings, LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, Prednisone
• Locations: 1 site (Roanoke, Virginia)
• Trial ID: NCT06767501 on ClinicalTrials.gov

What this trial studies

This clinical evaluation aims to compare the effectiveness of E-GRAFT™, a dehydrated amniotic allograft, against FIBRACOL™, a collagen alginate dressing, in treating non-healing diabetic foot ulcers. Participants will receive standard care alongside one of the two treatments, and the study will measure outcomes such as wound closure rates, ulcer size changes over 12 weeks, and any adverse events. The primary endpoint is the percentage of patients achieving complete closure of their target ulcer. Secondary endpoints include pain levels and the occurrence of infections.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 1 or 2 diabetes and a specific type of diabetic foot ulcer.

Not a fit: Patients with ulcers that do not meet the size or duration criteria, or those with severe underlying conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with non-healing diabetic foot ulcers.

How similar studies have performed: Other studies have shown promising results with similar approaches using amniotic allografts for wound healing, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.
2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.
4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

   1. TCOM ≥30 mmHg
   2. ABI between 0.7 and 1.3
   3. PVR: Biphasic
   4. TBI ˃0.6
   5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle.
8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
10. The subject must consent to using the prescribed off-loading method for the duration of the study.
11. The subject must agree to attend the weekly study visits required by the protocol.
12. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. A subject known to have a life expectancy of \< 6 months is excluded.
2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
4. Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
8. If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
13. A potential subject with end stage renal disease requiring dialysis is excluded.
14. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
15. Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.

Where this trial is running

Roanoke, Virginia

• Professional Education and Research Institute — Roanoke, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Charles M Zelen, DPM FACFAS — Professional Education and Research Institute
• Study coordinator: Adam Isaac, DPM

Conditions Diabetic Foot Ulcers