Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.
ConvaTec Inc.
Summary
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion: 1. Subjects at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age. 2. Known history of type 1 or type 2 diabetes. 3. The patient must have a target ulcer meeting the following characteristics: i. A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii. Located on the anatomical foot; defined as a minimum of 50% of ulcer area extending distal to the medial malleolus. iii. The target ulcer must have been present for a minimum of 4 weeks and no longer than 52 weeks. iv. The target ulcer must display evidence of delayed w…
Interventions
- DeviceInnovaMatrix® AC
SOC plus weekly application of the study device
Locations (9)
- Angel City ResearchLos Angeles, California
- Center for Clinical ResearchSan Francisco, California
- ILD Research CenterVista, California
- Dinamo Research and Diagnostic CenterHialeah, Florida
- Indiana Foot & AnkleJasper, Indiana
- US-FASHagerstown, Maryland