Nitric oxide–generating dressing for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects real-world data on the use of a nitric oxide–generating dressing (ConvaNiox) for diabetic foot ulcers. Eligible adults with diabetes and ulcers meeting specific size and type criteria are followed through procedures and follow-up evaluations to observe wound response and safety. The study uses site-based data from a single NHS trust in England to assess outcomes in routine care settings. No randomization or control group is described, and results will reflect everyday clinical practice. The investigation focuses on wound healing progress, infection status, and any dressing-related adverse events.

Why it matters

Who can join: the full rules

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 but \<2 cm from the wound margin and/or other local signs of infection (swelling, induration, tenderness, increased warmth, or purulent discharge), without involvement of deeper tissues (e.g., tendon, muscle, joint, or 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/day is permitted

EC-4 Active Charcot foot

Where it's running

• Tameside and Glossop Integrated Care NHS Foundation Trust
  Ashton-under-Lyne, England, United Kingdom Recruiting

Study contacts

• Study coordinator: Andrew Thomas
• Email: andrew.thomas@convatec.com
• Phone: +44 (0) 7791904279

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Miro3D Wound Matrix for Diabetic Foot Ulcers

  This study tests whether adding Miro3D Wound Matrix to standard care helps healing diabetic foot ulcers in adults.

  Recruiting at 6 sites Reprise Biomedical, Inc. · Phoenix, Arizona and 13 other locations · NCT07632001

• Nu-3 Gel at multiple doses for mildly infected diabetic foot ulcers

  A phase 2a study will test whether Nu-3 gel, applied on infected diabetic foot ulcers, can reduce bacteria and help heal at three different dose levels in adults with diabetes.

  Recruiting at 6 sites Phase 2 Lakewood-Amedex Inc · Los Angeles, California and 5 other locations · NCT07565506

• Using Miro3D Wound Matrix to Heal Diabetic Foot Ulcers

  This study is testing if adding a special wound dressing called Miro3D to regular care can help people with early-stage diabetic foot ulcers heal faster.

  Recruiting Reprise Biomedical, Inc. · Coconut Creek, Florida and 2 other locations · NCT06939686

• Using Miro3D Wound Matrix to Heal Complex Wounds

  This study is testing if a new wound treatment made from pig liver can help heal tough wounds and reduce pain for adults with chronic ulcers and other serious skin issues.

  Recruiting Reprise Biomedical, Inc. · Coconut Creek, Florida and 1 other locations · NCT06939673

• Comparing Amnion Membrane Allograft and Standard Care for Diabetic Foot Ulcers

  This study is testing whether a new amniotic membrane treatment can help heal diabetic foot ulcers better than a standard collagen dressing.

  Recruiting Skye Biologics Holdings, LLC · Roanoke, Virginia · NCT06767501

• Registry of Chronic Wounds and Ulcers

  This study collects information from patients with chronic wounds and ulcers to see how well different treatments are working and to improve the quality of wound care.

  Recruiting U.S. Wound Registry · The Woodlands, Texas · NCT02280733

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.