A Randomized Controlled Multicenter Trial Examining the Effect of Derm-Maxx ADM on the Healing Rate of Chronic Diabetic Foot Ulcers
Capsicure, LLC
Summary
This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers
Description
This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Derm-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age. 2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy. 3. Subjects with the following ulcer: A. 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 evalu…
Interventions
- OtherDerm-Maxx
Derm-Maxx™ Dermal Matrix is an acellular human dermis graft sterilized using the Tutoplast® Tissue Sterilization Process.
Locations (11)
- North Alabama Research Center, LLCAthens, Alabama
- Premium PodiatryEncino, California
- Royal ResearchHollywood, Florida
- Bioresearch PartnerMiami, Florida
- Bioresearch PartnerMiami Lake, Florida
- Wahab ResearchLas Vegas, Nevada