✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
N/A
Participants
ALL
Age Range
18 Years+
About This Trial
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
Who Can Join?
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, characterized by erythema >0.5…
⚠ Always speak to your doctor before applying to any clinical trial.