RecruitingDiabetic Foot Ulcer (DFU)Amnio-Maxx
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
Sponsor: Royal Biologics
You may qualify if…
- ✓ Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
- ✓ 1. The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
- ✓ 2. The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
- ✓ 3. Potential subjects have an ulcer characterized by the following:
- ✓ 1. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. \[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.\]
- ✓ 2. A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
- ✓ 4. Objectively, less than 20% healing in the two-week screening period prior to randomization.
- ✓ 5. Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
You may not qualify if…
- ✕ 1. The Subject has a known life expectancy of \< 1 year.
- ✕ 2. Index ulcer has been present for \>1 year.
- ✕ 3. Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
- ✕ 4. Subject is unable to comply with offloading device.
- ✕ 5. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- ✕ 6. Subject has ulcers that are completely necrotic or fibrotic tissue
- ✕ 7. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- ✕ 8. Subject currently being treated for an active malignant disease
Where it's recruiting
Source: ClinicalTrials.gov · NCT07209475 · last updated 2025-10-07