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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.