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Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers (ProNOx1)

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NOx dressing
Standard of Care
Sponsored by
Edixomed Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Nitric oxide, Nitric oxide dressing, NOx, NOx dressing, Diabetic, Foot, Ulcers, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St James's University Hospital
  • Ninewells Hospital
  • Edinburgh Royal Infirmary
  • Southern General Hospital
  • Kings College Hospital
  • Pennine Acute Hospitals Trust
  • Nottingham City Hospital
  • Lancashire Teaching Hospitals
  • Salford Royal
  • Pinderfields General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

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

Standard of Care

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2013
Last Updated
January 19, 2016
Sponsor
Edixomed Ltd
Collaborators
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01982565
Brief Title
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
Acronym
ProNOx1
Official Title
A Clinical Pilot Study of an Oxides of Nitrogen Generating Gel Dressing System to Stimulate Healing in Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edixomed Ltd
Collaborators
Queen Mary University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Nitric oxide, Nitric oxide dressing, NOx, NOx dressing, Diabetic, Foot, Ulcers, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
NOx dressing applied and changed at least every 2 days for 12 weeks or until ulcer is healed.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
NOx dressing
Intervention Description
The NOx dressing should be changed at least every 2 days.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
The clinician/podiatrist is free to use whichever treatment they would choose to use on the patient in their current clinical practice.
Primary Outcome Measure Information:
Title
Measure the safety of the NOx generating dressing
Description
Number of participants with adverse events during the active study period and the following 3 months post treatment
Time Frame
Monitored at every visit until 12 weeks or ulcer is healed and at 3 month post treatment followed
Title
Measure the efficacy of the NOx generating dressing
Description
The time to healing of the ulcer will be measured and compared between the NOx generating dressing arm and the standard of care arm
Time Frame
Measured at every patient visit until healed or 12 weeks of treatment is reached
Secondary Outcome Measure Information:
Title
Measure changes in ulcer blood flow.
Description
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.
Time Frame
3 months
Title
Measure changes in the inflammatory/infective status of the wounds.
Description
Samples taken at every visit will be measured for microbial content and inflammatory cytokine presence and a comparison made between the 2 arms.
Time Frame
Samples taken at every visit until 12 weeks or the ulcer is healed
Title
Measure the rate of repeat ulcers and breakdown in healing.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Tucker, PhD
Organizational Affiliation
St Barts, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Pennine Acute Hospitals Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Salford Royal
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Pinderfields General Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

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Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

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