Actively Recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Led by ConvaTec Inc. · Updated on 2025-12-17
298
Participants Needed
4
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EDX110 Randomized Control Trial for Treatment of DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants at least 18 years old and willing to complete all study procedures and follow-ups
- Have a non-healing diabetic foot ulcer (DFU) present for at least 4 weeks prior to enrollment
- Ulcer is a full-thickness wound (Wagner Grade 1) located on the foot below the ankle
- Ulcer may have mild infection defined as PEDIS grade 1 with specific local signs
- Ulcer duration between 1 month and less than 24 months
- Post-cleaning wound size between 0.1 cm² and 25 cm²
- If multiple ulcers, the index ulcer must be the largest and at least 3 cm away from others on the same limb
- Confirmed history of type 1 or type 2 diabetes
- Hemoglobin A1c below 12% or equivalent blood glucose levels
- Adequate blood circulation to the affected foot as defined by specified ischemia grades and vascular tests
You will not qualify if you...
- Ulcers classified as Wagner Grade 2 or higher, including deep ulcers, gangrene, or osteomyelitis
- Infections classified as PEDIS grade 3 or 4, or infections involving deeper tissues or systemic symptoms
- Presence of tunneling, cavity, or undermining wounds
- Known or suspected local skin cancer at the ulcer site
- Actively bleeding wounds (enrollment allowed after bleeding stops)
- Significant foot deformities interfering with healing or off-loading
- Active Charcot deformity
- Ulcer duration longer than 2 years
- Recent use of systemic corticosteroids above 10mg/kg/day or immunocompromised due to chemoradiation
- Use of advanced wound therapies on the study ulcer within 30 days
- Prior amputation on the affected leg
- Known allergy to product components
- Conditions impairing ability to follow the study protocol
- Women under 55 who are pregnant or breastfeeding
- Participation in another clinical trial concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Christina Mastandrea
CONTACT
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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