Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Biologics
About this trial
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.
Eligibility criteria
Qualifiers
The potential subject is 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
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.
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.]
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.
Disqualifiers
The Subject has a known life expectancy of < 1 year.
Index ulcer has been present for >1 year.
Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
Subject is unable to comply with offloading device.
Trial design
Treatments tested in this trial
- Amnio-Maxx® Dual Layer Amnion Patch
- Standard of Care (Investigator Choice)
Treatment groups
248 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov