Diabetic Foot Ulcers (DFUs)
Conditions
Keywords
Diabetic foot ulcers, Nitric Oxide, Wound, dressing, Woundcare
Brief summary
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
Interventions
DEVICEConvaNiox
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).
Sponsors
ConvaTec Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage area reduction | at 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of wound closure | at 12 weeks |
| Percentage area reduction | at 4 weeks |
| Incidence of >50% percentage area reduction | at 4 weeks |
Contacts
CONTACTAndrew Thomas
Outcome results
None listed