Wound HealingNCT06640985
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
A study testing EDX110 wound dressing system in people with Wound Healing and Diabetic Foot, run by ConvaTec Inc. at 1 site in Chile.
Trial summary
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic
- What is being tested?
- EDX110 wound dressing system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChile
- Study dates
- 4 Dec 2024to Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- An index ulcer meeting the following characteristics:
- Diabetic foot ulcer (DFU): Wagner Grade 1: partial- or full-thickness (superficial)
- DFU: Located on the anatomical foot; defined as distal to the medial malleolus
- Venous leg ulcer (VLU): Partial or full thickness
- VLU: Located below the knee and above the ankle
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- Presents with or without clinical signs of superficial infection
- Present for ≥4 weeks and <52 weeks
- Wounds will be dry to moderately exudating
- Post-debridement wound area is ≥0.5 cm2 and ≤25 cm2
- If two or more ulcers are present, the index ulcer must additionally be:
- The ulcer with the largest wound area
- ≥3cm distance from any other ulcer on the affected limb
- DFU: type 1 or type 2 diabetes (confirmed by the subject's medical history)
- DFU: HgbA1c <9% at screening
- GFR>30 mL/min/1,73m2
- Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following results within the past 30:
- Dorsum transcutaneous oxygen test (TcPO2): >30mmHg;
- Subject's Ankle-Brachial Index (ABI) by Doppler: ≥0.7 and ≤1.2;
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For Ankle-Brachial Pressure Index (ABPI): >1.2, for Toe Brachial Index (TBI): >0.5
- A total lymphocyte count of more than 1500 cells/mm3
- Albumin level of more than 3.5 g/dL
- Subject can ambulate at home or in the clinic with or without mobility aids
- BMI ≤45
Who cannot join
- Subjects with wounds that have any of the following characteristics:
- Wounds that penetrate down to tendon, ligament, joint capsule or bone, underlying muscle tissue, or organs
- Tunnelling wounds
- Known or suspected local skin malignancy at the site of the ulcer
- DFU: Major structural abnormalities of the foot
- DFU: Active Charcot deformity
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- VLU: inability to tolerate elastocompression (40 mm/hg)
- Wound duration >1 year
- Subjects receiving any of the following prior therapies:
- In the last 10 days:
- Chemical debridement
- Dakin's solution
- Medical honey therapy
- In the last 30 days (or anticipated to require such medications during the study period):
- Cytotoxic chemotherapy
- Application of topical steroids to the ulcer surface
- Use of ≥14 days of immune suppressants (including systemic corticosteroids) OR
- Subject is anticipated to require such medications during the study period
- In the last 30 days:
- o Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials
- In the last 6 months:
- Any amputation to the affected leg
- Revascularization (surgical or stenting) to the affected leg
- Known hypersensitivity to constituents of the product
- Osteomyelitis/bone infection of the affected foot/leg, as verified by x-ray within 30 days prior to screening
- Active cellulitis at the wound site
- History of radiation at the ulcer site, regardless of duration
- Chronic kidney disease stage 4 or 5
- Immune system disorders, including SLE, AIDS or HIV
- Presence of any other pathology that would limit blood supply and compromise healing
- Revascularization procedure to increase blood flow in the target limb
- 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
- Women of childbearing age (women aged <55 years who have not undergone menopause) who are:
- Pregnant at time of enrolment
- Planning to become pregnant during the time of the study
- Have been pregnant within the last 6 months
- Breast-feeding
- Unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the time of the study
- Concurrent enrolment in any other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Prospective Case Series Study to Determine the Efficacy and Safety of EDX110 in Hard-to-heal Wounds Resulting From Venous Insufficiency or Diabetes
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
Read the detailed description
Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Being tested
- EDX110 wound dressing system
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDX110 wound dressing systemDevice
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 |
|---|---|---|
| Diabetic Foot Ulcer (DFU) | Experimental | DFU treatment with EDX110 wound dressing Receives: Device: EDX110 wound dressing system |
| Venous Leg Ulcer (VLU) | Active comparator | VLU treatment with EDX110 wound dressing Receives: Device: EDX110 wound dressing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs
Percentage area reduction (PAR) of target wound at 12 weeks for each wound determined by wound measurements
Measured: 12 week
Secondary outcomes (3)
Efficacy of EDX110 in complete wound management and healing of hard-to-heal wounds
PAR of target wound as defined as 100% reepithelialization
Measured: 4 week
Effect of EDX110
Treatment effect by using the 17-item Wound Quality of Life (W-QoL) questionnaire, assessing how wound care has affected the quality of life in the last seven days, ranging from "Not at all" to "Very much"
Measured: Treatment, week 4 and 12
Tolerability of EDX110
Tolerability assessed by Visual Analog Scale (VAS), assessing overall impression and satisfaction, ranging from "Very Poor" to "Excellent"
Measured: up to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Dec 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeison David Peñuela, MD, Principal investigator, Convatec Medical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640985
- Sponsor's protocol ID
- WC-24-446
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Case Series Study to Determine the Efficacy and Safety of EDX110 in Hard-to-heal Wounds Resulting From Venous Insufficiency or Diabetes
- ClinicalTrials.gov ID
- NCT06640985
- Acronym / sponsor ID
- WC-24-446
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
Detailed description
Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcer (DFU) | Experimental | Device: EDX110 wound dressing systemDFU treatment with EDX110 wound dressing |
| Venous Leg Ulcer (VLU) | Active comparator | Device: EDX110 wound dressing systemVLU treatment with EDX110 wound dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- An index ulcer meeting the following characteristics:
- If two or more ulcers are present, the index ulcer must additionally be:
- DFU: type 1 or type 2 diabetes (confirmed by the subject's medical history)
- DFU: HgbA1c <9% at screening
Key exclusion criteria (39 listed)
- Subjects with wounds that have any of the following characteristics:
- Tunnelling wounds
- Subjects receiving any of the following prior therapies:
- o Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials
- Known hypersensitivity to constituents of the product
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 |
|---|---|---|
| EDX110 wound dressing systemEDX110 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 | Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU) |
Primary outcome
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs
Time frame: 12 week
Percentage area reduction (PAR) of target wound at 12 weeks for each wound determined by wound measurements
3 secondary outcomes
Efficacy of EDX110 in complete wound management and healing of hard-to-heal wounds
Time frame: 4 week
Effect of EDX110
Time frame: Treatment, week 4 and 12
Tolerability of EDX110
Time frame: up to 12 week
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 23 Dec 2025.
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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.
Jeison David Peñuela, MD principal investigator
Convatec Medical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDX110 wound dressing system in people with Wound Healing and Diabetic Foot, run by ConvaTec Inc. at 1 site in Chile.
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 24 inclusion and 39 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs (time frame: 12 week). 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 23 Dec 2025.