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Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

NCT01982565 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2016-01-20

No results posted yet for this study

Summary

This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic DFUs compared to standard of care.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

NOx dressing

The NOx dressing should be changed at least every 2 days.

OTHER

Standard of Care

The clinician/podiatrist is free to use whichever treatment they would choose to use on the patient in their current clinical practice.

Sponsors & Collaborators

  • Queen Mary University of London

    collaborator OTHER

  • Edixomed Ltd

    lead INDUSTRY

Principal Investigators

  • Arthur Tucker, PhD · St Barts, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982565 on ClinicalTrials.gov