Actively Recruiting
A Multi-Centre, Observer-Blinded, Randomized Controlled Trial of EDX110 for the Treatment of Diabetic Foot Ulcers
Led by ConvaTec Inc. · Updated on 2025-12-17
298
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the EDX110 dressing system to the usual treatment can improve healing of diabetic foot ulcers. This is a prospective, multi-center, observer-blinded randomized controlled trial comparing EDX110 plus standard care to standard care alone in adults with diabetic foot ulcers. The study is sponsored by ConvaTec Inc. and aims to assess wound closure and healing progress over several weeks. Participants will be randomly assigned to one of two groups: one receiving the EDX110 wound dressing system along with standard care and the other receiving only the traditional standard of care for diabetic foot ulcers. The EDX110 device includes two layers designed to generate nitric oxide on the wound, manage moisture, and help with wound cleaning. Treatment duration and follow-up extend up to 24 weeks to monitor healing outcomes. During the study, participants will undergo regular assessments to measure wound closure at 16 weeks as the primary outcome, with additional evaluations at 4, 16, and 24 weeks to track wound size reduction and healing time. Researchers will monitor the wounds and overall health throughout the trial, ensuring adherence to study procedures and safety. Total participation duration varies but includes follow-up visits to evaluate the wound healing progress and safety of the treatments.
CONDITIONS
Brief Title
EDX110 Randomized Control Trial for Treatment of DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old and willing to complete all study procedures and follow-ups.
- Have a non-healing diabetic foot ulcer present for at least 4 weeks before enrollment.
- Ulcer must be full-thickness, classified as Wagner Grade 1 (superficial skin or subcutaneous tissue ulcer).
- Ulcer located on the foot, below the medial or lateral ankle bone.
- May have mild superficial infection (PEDIS grade 1) as defined by specific clinical signs.
- Ulcer duration between 1 month and less than 24 months at randomization.
- Post-debridement wound area between 0.1 cm2 and 25 cm2.
- If multiple ulcers present, the largest ulcer separated by at least 3 cm from others is selected.
- Confirmed history of type 1 or type 2 diabetes.
- Hemoglobin A1c less than 12% or average blood glucose below 298 mg/dL.
- Adequate blood circulation to the affected foot as defined by specific circulation tests (WIfI grades 0-1).
- Must meet at least one of these circulation criteria: Ankle-Brachial Index ≥0.6, Toe-Brachial Index ≥0.5, or transcutaneous oxygen test >40 mm/Hg.
You will not qualify if you...
- Ulcers classified as Wagner Grade 2 or higher, involving deeper tissues, bone infection, gangrene, or severe foot damage.
- Infections classified as PEDIS grade 3 or 4 indicating moderate to severe infection or systemic inflammation.
- Confirmed bone infection by imaging or clinical tests.
- Presence of cellulitis, lymphangitis, soft tissue gas, or necrotizing fasciitis from the wound.
- Wounds with tunneling, cavity, or undermining.
- Local skin cancer at the ulcer site.
- Actively bleeding wounds (until bleeding stops).
- Severe foot deformities that prevent proper off-loading or healing.
- Active Charcot foot deformity.
- Wound duration longer than 2 years.
- Recent use (within 30 days) of systemic corticosteroids above specified doses or recent cancer chemoradiation causing immunocompromise.
- Use of advanced wound therapies within the last 30 days.
- Prior amputation on the affected leg.
- Known allergy to the study product components.
- Conditions impairing understanding or compliance with the study.
- Women of childbearing age who are pregnant or breastfeeding.
- Participation in another clinical study concurrently.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 16 weeks
Participants receive treatment with the EDX110 wound dressing system combined with standard care or standard care alone for diabetic foot ulcers.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 4 locations
1
Axentra Bio
Phoenix, Arizona, United States, 85053
Actively Recruiting
2
Clemente Clinical Research
Santa Ana, California, United States, 92704
Actively Recruiting
3
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
4
Futuro Clinical Trials
McAllen, Texas, United States, 78501
Actively Recruiting
Research Team
A
Andrea M Picchietti
C
Christina Mastandrea
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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