ConvaTec Inc.
Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing compared to just using standard of care.
Inclusion Criteria: * Participants at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study. * The participant must have an index ulcer meeting the following characteristics: 1. Non-healing DFU defined as; at least 4 weeks prior to enrolment the ulcer has failed to progress on a healing trajectory. 2. Full-thickness wound; defined as Wagner Diabetic Foot Ulcer Grade 1 - superficial ulcer of skin or subcutaneous tissue. 3. Located on the anatomical foot; defined as distal to the medial or lateral malleolus. * Presents w…
EDX110 wound dressing system EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement
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