RecruitingDiabetic FootUlcer FootFoot Ulcer
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Sponsor: Axolotl Biologix
You may qualify if…
- ✓ 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;
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Thousand Oaks
Source: ClinicalTrials.gov · NCT06550596 · last updated 2025-01-30