NCT01982565

Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

A Clinical Pilot Study of an Oxides of Nitrogen Generating Gel Dressing System to Stimulate Healing in Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Edixomed Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a clinical study of a new wound dressing for diabetic foot ulcers (DFU). The dressing consists of 2 stable layers that when placed together release Nitric Oxide. In preclinical studies NOx delivery has caused significant vasodilation, angiogenesis and demonstrated potent anti-microbial activity. In part 1 of the study, the dressing will be applied to up to 20 DFUs for a set period and the blood flow in and around the wound will be measured before and after application of the dressing. Any adverse events will be recorded. If an increase in blood flow is seen and the dressing is well tolerated, part 2 will begin, which is a multi-centre, 120 patient, randomised, controlled study. 60 patients with chronic DFUs will be treated with the NOx generating dressing and 60 patients will continue to receive standard of care. The efficacy and the tolerability of the dressing will be measured. The NOx dressing will be changed at least every 2 days and the standard of care changed as in normal clinical practice. At weekly clinical visits the diameter, area and volume of the wound will be measured. The infective status of the wound will be assessed and the inflammatory profile of the wound will be measured.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2013-11-13
• Last updated: 2016-01-20

Locations

10 sites across 1 country: United Kingdom