Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

NCT01982565 | Completed Phase 1 DMC

• 1 other identifier: EDX 110
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Nitric oxide; Nitric oxide dressing; NOx; NOx dressing; Diabetic; Foot; Ulcers; Chronic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Measure changes in ulcer blood flow.

  3 months

• Measure changes in the inflammatory/infective status of the wounds.

  Samples taken at every visit until 12 weeks or the ulcer is healed

• Measure the rate of repeat ulcers and breakdown in healing.

  1 year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

NOx dressing applied and changed at least every 2 days for 12 weeks or until ulcer is healed.

Device: NOx dressing

Control Arm

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Interventions

NOx dressing DEVICE

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

Treatment Arm

Standard of Care OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edixomed Ltd: lead
• Queen Mary University of London: collaborator

Study Sites (10)

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Pennine Acute Hospitals Trust

Manchester, M8 5RB, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Lancashire Teaching Hospitals

Preston, PR2 9HT, United Kingdom

Location

Salford Royal

Salford, M6 8HD, United Kingdom

Location

Pinderfields General Hospital

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Bronchiolitis Obliterans Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Arthur Tucker, PhD

  St Barts, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 13, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

GB (10)