EDX110 Randomized Control Trial for Treatment of DFUs (NCT07209358) | Clinical Trial Compass
RecruitingNot Applicable
EDX110 Randomized Control Trial for Treatment of DFUs
United States298 participantsStarted 2025-10-30
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Non-healing DFU defined as; at least 4 weeks prior to enrolment the ulcer has failed to progress on a healing trajectory.
✓. Full-thickness wound; defined as Wagner Diabetic Foot Ulcer Grade 1 - superficial ulcer of skin or subcutaneous tissue.
✓. Located on the anatomical foot; defined as distal to the medial or lateral malleolus.
✓. The ulcer with the largest wound area, as long as it meets all other criteria.
✓. ≥3cm distance from any other ulcer on the affected limb
✓. Ankle-Brachial Index (ABI) by Doppler: ≥0.6 OR Toe-Brachial Index (TBI) ≥ 0.5
✓. OR Dorsum transcutaneous oxygen test (TcPO2): \>40 mm/Hg
Exclusion criteria
✕. Wagner Grade 2 - ulcers extend into tendon, bone, or capsule
✕. Grade 3 - deep ulcer with osteomyelitis, or abscess
✕. Grade 4 - partial foot gangrene
✕. Grade 5 - whole foot gangrene
✕. PEDIS 3 (Moderate): Infection with no systemic manifestations and involving: Erythema extending ≥2 cm2 from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone).
. PEDIS 4 (Severe): All of the above in PEDIS 3 plus manifestations (of the systemic inflammatory response syndrome \[SIRS\]).
✕. In addition, any diabetic foot infections with; Confirmed underlying bone involvement (osteomyelitis) based on; imaging (plain X-ray, CT or MRI), clinical examination (exposed bone or positive probe to bone test) or culture/histopathology of a bone specimen
✕. OR Cellulitis/lymphangitis/soft tissue gas or necrotizing fasciitis originating from the wound site.