ONWARDNitric Oxide Generating Dressing for Diabetic Foot Ulcers Treatment
This observational study aims to assess the percentage area reduction of diabetic foot ulcers when treated with a nitric oxide generating dressing.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+11
+ Diabetes Mellitus
+ Diabetic Angiopathies
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 1, 2026
Actual date on which the first participant was enrolled.This study focuses on diabetic foot ulcers, a common complication in people with diabetes. The main goal is to test the effectiveness and safety of a special dressing called ConvaNiox™. This dressing generates nitric oxide, a gas known to help wounds heal. By conducting this study, researchers aim to find a better way to treat diabetic foot ulcers, potentially improving the quality of life for those affected by this condition. During the study, participants with diabetic foot ulcers will use the ConvaNiox™ dressing. The primary outcome measured is the percentage reduction in the area of the ulcer. This helps determine if the dressing is effective in promoting wound healing. As an observational study, it will also monitor the safety of the dressing, ensuring it doesn't cause any unexpected side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.102 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives