Tides Medical
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study. 1. At least 18 years old, inclusive. 2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus. 3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer. 4. Index ulcer ha…
Placental-based Allografts