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EDX110 for Diabetic Foot Ulcers

This study is testing a new wound dressing system called EDX110 for people with diabetic foot ulcers (DFUs). DFUs are open sores or wounds that commonly occur in people with diabetes. The study wants to see if adding the EDX110 dressing to standard care helps these ulcers heal better than standard care alone. You might be able to join if you are 18 to 90 years old and have a DFU that hasn't healed for at least four weeks. The main goal is to see how many ulcers close completely within 16 weeks. The current recruitment status is unclear.

Study design
This is a prospective, multi-centered, observer-blinded, randomized control trial. About 298 participants are planned to be enrolled, with half receiving EDX110 plus standard care and the other half receiving only standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for wound closure is measured at 16 weeks.

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NCT07209358

EDX110 Randomized Control Trial for Treatment of DFUs

Recruiting
NAAges 18–90InterventionalTreatment
ConvaTec Inc.
~298 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:EDX110

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound Closure
Measured over 16 Weeks

Conditions

Wound Heal
Diabetic Foot Ulcer

Explore related trials

Diabetic foot ulcer

Where it's being run

4 sites across 3 states
California2
Arizona1
Texas1

Study leadership

  • Christina M Mastandrea, MS · STUDY_DIRECTOR · ConvaTec Inc.

Who to contact

Andrea M Picchietti
[email protected]
2604189196
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Presents with or without clinical signs of superficial infection. Infection is defined using International Working Group of the Diabetic Foot (IWGDF) PEDIS classification and for the purpose of inclusion infections must be PEDIS grade 1 (Mild); Infected: At least two of these items are present: Local swelling or induration Erythema \>0.5 but \<2 cm2 around the wound, Local tenderness or pain, Local increased warmth, Purulent discharge.
Ulcer duration at randomization must be present for ≥1 month but less than \<24 months in duration.
Post-debridement wound area is ≥0.1 cm2 and ≤25 cm2.
If two or more ulcers either mono or bilateral are present, the index ulcer must additionally be:
Known history of type 1 or type 2 diabetes (confirmed by the subject's medical history).
HgbA1c \<12% (NGSP) OR 108 mmol/mol (IFCC) OR average blood glucose 298 mg/DL.
Participant has adequate circulation to the affected extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grades 0-1 (no PAD to Mild PAD).
Participants are required to have either.

Exclusion

Participants with wounds that have any of the following characteristics:
Infections that are classified as:
Tunnelling, Cavity or undermining wounds.
Known or suspected local skin malignancy at the site of the ulcer.
A wound that is actively bleeding. This does not exclude enrollment once active bleeding has stopped (hemostasis).
Gross Foot deformities that would interfere with proper off-loading or proper wound healing i.e. non-active charcot foot, rocker bottom foot, gross digital deformities.
Active Charcot deformity.
Wound duration \>2 years.
Participants receiving any of the following prior therapies. In the last 30 days:
Known hypersensitivity to constituents of the product.
Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study protocol in the judgement of the Investigator.
Women of childbearing age (women aged \<55 years who have not undergone menopause) who are:
Concurrent enrolment in any other study.

What this trial measures

  • Wound Closure16 Weeks

    Incidence of complete wound closure at 16 weeks in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC. Wound closure is defined as 100% reepithelialization of the wound without drainage.