A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.

NCT07438951 | Not Yet Recruiting

• 1 other identifier: WC-25-465
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Keywords

Diabetic foot ulcers; Nitric Oxide; Wound; dressing; Woundcare

Outcome Measures

Primary Outcomes (1)

• Percentage area reduction

  at 12 weeks

Secondary Outcomes (3)

• Incidence of wound closure

  at 12 weeks

• Percentage area reduction

  at 4 weeks

• Incidence of >50% percentage area reduction

  at 4 weeks

Study Arms (1)

Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox

Device: ConvaNiox

Interventions

ConvaNiox DEVICE

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).

Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• Only PEDIS 2 infections are permitted - Mild superficial skin and soft tissue infections with no systemic manifestations and involving:
• Erythema extending ≥2 cm from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone)
• IC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;
• 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

You may not qualify if:

• 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/kg/day is permitted
• EC-4 Active Charcot foot

Sponsors & Collaborators

• ConvaTec Inc.: lead

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Andrew Thomas

CONTACT

+44 (0) 7791904279; andrew.thomas@convatec.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share