Using dehydrated human amnion membrane to treat nonhealing diabetic foot ulcers

A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

This study is testing if adding dehydrated human amnion membrane to regular care can help people with stubborn diabetic foot ulcers heal better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Axolotl Biologix (Industry-sponsored)
• Drugs / interventions: chemotherapy, Prednisone
• Locations: 1 site (Thousand Oaks, California)
• Trial ID: NCT06550596 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of dehydrated human amnion membrane (dhAM) combined with standard care versus standard care alone in promoting the healing of nonhealing diabetic foot ulcers (DFUs). It is a multi-center randomized controlled trial that aims to determine if the addition of dhAM can enhance wound closure rates. Participants will be monitored for their ulcer healing progress over a specified period, with assessments made based on ulcer size and healing status.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with type 1 or 2 diabetes and specific characteristics of nonhealing foot ulcers.

Not a fit: Patients with ulcers that are Wagner grade 3 or higher, or those with exposed tendon or bone, may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown promise in using amnion membranes for wound healing, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Subjects must be at least 18 years of age or older.
* Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
* At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.
* 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.
* The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
* The 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.
* 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.
* 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.
* The subject must consent to using the prescribed offloading method for the duration of the study.
* The subject must agree to attend the weekly study visits required by the protocol.
* The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

* A subject known to have a life expectancy of \< 6 months is excluded.
* The subject is excluded if the target ulcer is not secondary to diabetes.
* If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
* If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
* A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
* A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
* The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
* A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
* 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).
* 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.
* A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
* A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
* Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
* A potential subject with end stage renal disease requiring dialysis is excluded.
* A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
* A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

Where this trial is running

Thousand Oaks, California

• Performance Foot and Ankle Specialists — Thousand Oaks, California, United States (Recruiting)

Study contacts

• Study coordinator: Bennett M Rogers

Conditions Diabetic Foot; Ulcer Foot; Foot Ulcer; Diabetic Foot Ulcer; Cellular, Acellular, Matrix-like Product; Dehydrated Human Amnion Membrane; Vascular Diseases; Leg Ulcer