Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— ProNOx1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982565
• Other study ID #: EDX 110
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 24, 2013
• Last updated: January 19, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Edixomed Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged over 18 years.

• Diagnosed with type 1 or type 2 diabetes.

• With a chronic (present for at least 6 weeks) full-thickness foot ulcer (on or below the malleoli) not penetrating to tendon, periosteum or bone, and with a cross-sectional area between 25 and 2500 mm2.

• Patients must have pedal blood flow between normal and moderately ischaemic. Measurable as a palpable pedal pulse or in the absence of a palpable pedal pulse they must have a TcPO2 of =30mmHg or an ABPI of between 0.5-1.00, or > 1.2. (An ABPI of >1.2 is associated with calcification rather than ischaemia. We are including patients with an ABPI >1.2 because ABPI is measured in large arteries. NOx has the ability to dilate medium to small arterioles which are less likely to be calcified.)

• With some degree of neuropathy (as commonly seen in the Diabetes Foot Clinic).

• Able to read and understand the Volunteer Information Sheet and to provide meaningful written informed consent.

• Able and willing to follow the Protocol requirements.

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding

• Any other serious disease likely to compromise the outcome of the trial

• Participation in any clinical study during the eight (8) weeks preceding the dosing period of the study

• Wound area greater than 2500 square mm;

• Patients with severe ischaemia. Measurable as absence of palpable pedal pulse and a TcPO2 of less than 30mmhg, or ABPI < 0.5 or between 1.0-1.2.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Edinburgh Royal Infirmary	Edinburgh
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	St James's University Hospital	Leeds	West Yorkshire
United Kingdom	Kings College Hospital	London
United Kingdom	Pennine Acute Hospitals Trust	Manchester
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Lancashire Teaching Hospitals	Preston
United Kingdom	Salford Royal	Salford
United Kingdom	Pinderfields General Hospital	Wakefield

Sponsors (2)

Lead Sponsor	Collaborator
Edixomed Ltd	Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the safety of the NOx generating dressing	Number of participants with adverse events during the active study period and the following 3 months post treatment	Monitored at every visit until 12 weeks or ulcer is healed and at 3 month post treatment followed	Yes
Primary	Measure the efficacy of the NOx generating dressing	The time to healing of the ulcer will be measured and compared between the NOx generating dressing arm and the standard of care arm	Measured at every patient visit until healed or 12 weeks of treatment is reached	No
Secondary	Measure changes in ulcer blood flow.	In Part 1 of the study, blood flow in the ulcer will be measured by laser Doppler fluximetry before and after the NOx generating dressing is applied.	3 months	No
Secondary	Measure changes in the inflammatory/infective status of the wounds.	Samples taken at every visit will be measured for microbial content and inflammatory cytokine presence and a comparison made between the 2 arms.	Samples taken at every visit until 12 weeks or the ulcer is healed	No
Secondary	Measure the rate of repeat ulcers and breakdown in healing.		1 year	No