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

Convatec

Status: Begins enrollment in 2 months

Conditions: Diabetic Foot Ulcers (DFUs)

Treatments: Device: ConvaNiox

Study type: Observational

Funder types: Industry

Identifiers

NCT07438951

WC-25-465

Details and patient eligibility

About

Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 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;

1. Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND
2. Ankle Brachial Index (ABI) >0.6 OR Toe Brachial Index (TBI) >0.5, OR
3. Toe pressure >40mmHg

Exclusion criteria

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

Trial design

102 participants in 1 patient group

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

Treatment:

Device: ConvaNiox