ClinicaliQ Trial Snapshot
- Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD) — Recruiting • Cardiology / Cardiovascular • NCT07438951.
- Sponsor: ConvaTec Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
Eligibility Snapshot
- : 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 .6 OR Toe Brachial Index (TBI) >0.5, OR 3. Toe pressure >40mmHg
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.