Wound HealNCT07209358
EDX110 Randomized Control Trial for Treatment of DFUs
A study testing EDX110 in people with Wound Heal and Diabetic Foot Ulcer, run by ConvaTec Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Heal, Diabetic Foot Ulcer
- What is being tested?
- EDX110
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Oct 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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.
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- 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:
- 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
- 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.
- Ankle-Brachial Index (ABI) by Doppler: ≥0.6 OR Toe-Brachial Index (TBI) ≥ 0.5
- OR Dorsum transcutaneous oxygen test (TcPO2): >40 mm/Hg
Who cannot join
- Participants with wounds that have any of the following characteristics:
- 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
- Infections that are classified as:
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- 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.
- 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:
- Has required systemic corticosteroids >10mg/kg/day OR
- Participant has required Chemoradiation (chemotherapy and/or radiation therapy) to treat cancer and is immunocompromised OR
- Participant is anticipated to require such medications during the study period.
- Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g., Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g., OASIS® Wound Matrix, MatriStem Wound Matrix).
- Has undergone any amputation to the affected leg.
- 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:
- Pregnant at time of enrolment
- Breast-feeding
- Concurrent enrolment in any other study.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Herco Medical Center
Flagami, Florida, 33126
Keck Medicine of USC
Los Angeles, California, 90033
Futuro Clinical Trials
McAllen, Texas, 78501
Gateway Clinical Trials
O'Fallon, Illinois, 62269
Advanced Foot Care
Phoenix, Arizona, 85053
OHSU
Portland, Oregon, 97239
University of Texas Health Science Center
San Antonio, Texas, 78229
Clemente Clinical Research
Santa Ana, California, 92704
ILD Research Center
Vista, California, 92081
Puerto Rico1 site
Clinical Research Management Group
Mayagüez, Puerto Rico, 00680
About this study
Official title: A Multi-Centre, Observer-Blinded, Randomized Controlled Trial of EDX110 for the Treatment of Diabetic Foot Ulcers
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
- Wound Heal, Diabetic Foot Ulcer
- Being tested
- EDX110
- Keywords
- Hard to heal wounds
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDX110Device
EDX110 wound dressing system EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement
| Study group | Role | What they receive |
|---|---|---|
| EDX110 with Standard of Care (SOC) | Active comparator | Diabetic Foot Ulcer (DFU) DFU treatment with EDX110 wound dressing and SOC Receives: Device: EDX110 |
| Standard of Care (SOC) | No intervention | Diabetic Foot Ulcer (DFU) DFU treatment with using only traditional Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
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.
Measured: 16 Weeks
Secondary outcomes (4)
Time to Wound Closure
Time to complete wound closure during treatment period in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Measured: 16 Weeks
Percent Area Reduction 4 weeks
The difference in the mean Percent Area of Reduction (PAR) at 4 weeks compared to baseline in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Measured: 4 Weeks
Percent Area Reduction 16 weeks
The difference in the mean Percent Area of Reduction (PAR) at 16 weeks compared to baseline in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Measured: 16 weeks
Wound closure at 24 weeks
Incidence of complete wound closure at 24 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start30 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina M Mastandrea, MS, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209358
- Sponsor's protocol ID
- WC-24-447
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Observer-Blinded, Randomized Controlled Trial of EDX110 for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07209358
- Acronym / sponsor ID
- WC-24-447
- Conditions
- Wound Heal, Diabetic Foot Ulcer
- Keywords
- Hard to heal wounds
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDX110 with Standard of Care (SOC) | Active comparator | Device: EDX110Diabetic Foot Ulcer (DFU) DFU treatment with EDX110 wound dressing and SOC |
| Standard of Care (SOC) | No intervention | –Diabetic Foot Ulcer (DFU) DFU treatment with using only traditional Standard of Care (SOC) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDX110EDX110 wound dressing system EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement | Device | EDX110 with Standard of Care (SOC) |
Primary outcome
Wound Closure
Time frame: 16 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.
4 secondary outcomes
Time to Wound Closure
Time frame: 16 Weeks
Percent Area Reduction 4 weeks
Time frame: 4 Weeks
Percent Area Reduction 16 weeks
Time frame: 16 weeks
Wound closure at 24 weeks
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Mastandrea, MS study director
ConvaTec Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDX110 in people with Wound Heal and Diabetic Foot Ulcer, run by ConvaTec Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.