Diabetic Foot Ulcers (DFUs)ONWARDNCT07438951
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
An observational study of Diabetic Foot Ulcers (DFUs), run by ConvaTec Inc. at 1 site in United Kingdom.
Trial summary
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs)
- What is being tested?
- ConvaNiox
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to Sep 2027
- Phase
- Observational
- 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
Study population: All subjects over the age of 18 years with a non-healing DFU (defined as failing to progress on a healing trajectory in the previous 4 weeks prior to enrolment) and treated with ConvaNiox (EDX110) will be screened for eligibility based on medical record review and discussions with the subject and their treating physician.
Who may be able to join
- IC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- IC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:
- IC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer
- IC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.
- Only PEDIS 2 infections are permitted. Mild superficial skin and soft tissue infections with no systemic manifestations, characterized by erythema >0.5 but <2 cm from the wound margin and/or other local signs of infection (swelling, induration, tenderness, increased warmth, or purulent discharge), without involvement of deeper tissues (e.g., tendon, muscle, joint, or bone).
- IC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;
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- Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND
- Ankle Brachial Index (ABI) >0.6 OR Toe Brachial Index (TBI) >0.5, OR
- Toe pressure >40mmHg
Who cannot join
- EC-1 Ulcers that are tunnelling or have cavities (>10mm in depth)
- EC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped
- EC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids <10mg/day is permitted
- EC-4 Active Charcot foot
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claudia Schroeder contact
United Kingdom1 site, 1 recruiting
- Recruiting
Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne, England, OL6 9RW
0161 922 6000
About this study
Official title: A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Being tested
- ConvaNiox
- Keywords
- Diabetic foot ulcers, Nitric Oxide, Wound, dressing, Woundcare
- Medical subject headings
- Diabetic Foot, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConvaNioxDevice
At each visit subjects will receive their Standard of Care (SoC) treatment for their DFU, but instead of their normal primary dressing they will receive an application of ConvaNiox (EDX110).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox | Not described Receives: Device: ConvaNiox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage area reduction
Difference between wound area at day 0 and 12 weeks of treatment
Measured: at 12 weeks
Secondary outcomes (3)
Incidence of wound closure
Difference between wound area at day 0 and 12 weeks of treatment
Measured: at 12 weeks
Percentage area reduction
Difference between wound area at day 0 and 4 weeks of treatment
Measured: at 4 weeks
Incidence of >50% percentage area reduction
Difference between wound area at day 0 and 4 weeks of treatment
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcers (DFUs)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Mastandrea, Study director, Medical & Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438951
- Sponsor's protocol ID
- WC-25-465
- Acronym
- ONWARD
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).
- ClinicalTrials.gov ID
- NCT07438951
- Acronym / sponsor ID
- ONWARD / WC-25-465
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Keywords
- Diabetic foot ulcers, Nitric Oxide, Wound, dressing, Woundcare
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox | – | Device: ConvaNiox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects over the age of 18 years with a non-healing DFU (defined as failing to progress on a healing trajectory in the previous 4 weeks prior to enrolment) and treated with ConvaNiox (EDX110) will be screened for eligibility based on medical record review and discussions with the subject and their treating physician.
Key inclusion criteria (9 listed)
- IC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- IC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:
- IC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer
- IC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.
- Only PEDIS 2 infections are permitted. Mild superficial skin and soft tissue infections with no systemic manifestations, characterized by erythema >0.5 but <2 cm from the wound margin and/or other local signs of infection (swelling, induration, tenderness, increased warmth, or purulent discharge), without involvement of deeper tissues (e.g., tendon, muscle, joint, or bone).
Key exclusion criteria (4 listed)
- EC-1 Ulcers that are tunnelling or have cavities (>10mm in depth)
- EC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped
- EC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids <10mg/day is permitted
- EC-4 Active Charcot foot
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 |
|---|---|---|
| ConvaNioxAt each visit subjects will receive their Standard of Care (SoC) treatment for their DFU, but instead of their normal primary dressing they will receive an application of ConvaNiox (EDX110). | Device | Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox |
Primary outcome
Percentage area reduction
Time frame: at 12 weeks
Difference between wound area at day 0 and 12 weeks of treatment
3 secondary outcomes
Incidence of wound closure
Time frame: at 12 weeks
Percentage area reduction
Time frame: at 4 weeks
Incidence of >50% percentage area reduction
Time frame: at 4 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 26 Oct 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.
Claudia Schroeder contact
Christina Mastandrea study director
Medical & Clinical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcers (DFUs), run by ConvaTec Inc. at 1 site in United Kingdom.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 United Kingdom. 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?
Contact Andrew Thomas (+44 (0) 7791904279, andrew.thomas@convatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage area reduction (time frame: at 12 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 26 Oct 2026.