NCT01982565: ProNOx1

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

Completed Phase 1/Phase 2 Last updated 19 January 2016

What this trial tests

Phase 1/Phase 2 trial testing NOx dressing in Diabetic Foot Ulcer in 130 participants. Completed in 1 December 2015.

Timeline

1 June 2013

Primary endpoint
1 June 2015

1 December 2015

Quick facts

Lead sponsor	Edixomed Ltd
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	1 June 2013
Primary completion	1 June 2015
Estimated completion	1 December 2015
Sites	10 locations across United Kingdom

Drugs / interventions tested

• NOx dressing
• Standard of Care

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Edixomed Ltd

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Measure the safety of the NOx generating dressing
  Time frame: Monitored at every visit until 12 weeks or ulcer is healed and at 3 month post treatment followed
  Number of participants with adverse events during the active study period and the following 3 months post treatment
• Measure the efficacy of the NOx generating dressing
  Time frame: Measured at every patient visit until healed or 12 weeks of treatment is reached
  The time to healing of the ulcer will be measured and compared between the NOx generating dressing arm and the standard of care arm

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nitric Oxide in Biomaterial-Based Therapies for Coronary Heart Disease: Mechanistic Insights, Current Advances, and Translational Prospects.
   Sun J, Wang Z, Sun Y, Zhang J, et al · · 2025 · cited 1× · PMID 41080652 · DOI 10.34133/bmr.0267