Evaluating a new placental-based treatment for diabetic foot ulcers

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

This study is testing if a new placental treatment can help adults with hard-to-heal diabetic foot ulcers get better faster when used alongside regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Applied Biologics, LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, Prednisone
• Locations: 1 site (Clinton Township, Michigan)
• Trial ID: NCT06564831 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized controlled multicenter evaluation of the efficacy of a single layer amniotic membrane (SLAM) combined with standard care versus standard care alone for treating nonhealing diabetic foot ulcers (DFUs). The study utilizes XWRAP®, an allograft derived from human amniotic tissue, designed to act as a protective barrier and promote healing. Participants will be monitored for ulcer closure over a specified period, with eligibility criteria focusing on adults with specific types of diabetic foot ulcers. The trial aims to determine if the addition of SLAM can significantly improve healing outcomes compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with type 1 or 2 diabetes and nonhealing foot ulcers meeting specific size and duration criteria.

Not a fit: Patients with ulcers that are not classified as Wager 1 or 2 grade or those with exposed tendon or bone may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance healing rates for patients suffering from diabetic foot ulcers, potentially reducing complications and improving quality of life.

How similar studies have performed: Previous studies using placental-based allografts have shown promise in wound healing, suggesting potential success for this approach.

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 ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
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 Wager 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.
7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

   1. ABI ≥ 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 40 mmHg;
   4. PVR: biphasic.
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. The subject must consent to using the prescribed off-loading method for the duration of the study.
10. The subject must agree to attend the weekly study visits required by the protocol.
11. 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. The subject is excluded if the target ulcer is not secondary to diabetes.
3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
9. The potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
10. The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial 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).
11. The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit during which time the subject received SOC.
12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
13. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
14. A potential subject with end stage renal disease requiring dialysis is excluded.
15. A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
16. A 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.
17. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.

Where this trial is running

Clinton Township, Michigan

• Detroit Foot and Ankle — Clinton Township, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Bennett Rogers

Conditions Diabetic Foot Ulcer; Diabetic Foot; Foot Ulcer; Ulcer Foot; DFU