A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ConvaNiox.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcers (DFUs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).
Overview
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
Interventions
- Device ConvaNiox
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).
Primary outcome measures
- Percentage area reduction [Time frame: at 12 weeks]
Secondary outcome measures (3)
- Incidence of wound closure [Time frame: at 12 weeks]
- Percentage area reduction [Time frame: at 4 weeks]
- Incidence of >50% percentage area reduction [Time frame: at 4 weeks]
Eligibility 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;
- Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND
- Ankle Brachial Index (ABI) >0.6 OR Toe Brachial Index (TBI) >0.5, OR
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07438951 · WC-25-465