Diabetic Foot UlcerPhase 1/2ProNOx1NCT01982565
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
A Phase 1/2 study testing NOx dressing in people with Diabetic Foot Ulcer, run by Edixomed Ltd at 10 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- NOx dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jun 2013to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Ninewells Hospital
Dundee, DD1 9SY
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
Southern General Hospital
Glasgow, G51 4TF
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Kings College Hospital
London, SE5 9RS
Pennine Acute Hospitals Trust
Manchester, M8 5RB
Nottingham City Hospital
Nottingham, NG5 1PB
Lancashire Teaching Hospitals
Preston, PR2 9HT
Salford Royal
Salford, M6 8HD
Pinderfields General Hospital
Wakefield, WF1 4DG
About this study
Official title: A Clinical Pilot Study of an Oxides of Nitrogen Generating Gel Dressing System to Stimulate Healing in Diabetic Foot Ulcers
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.
Read the 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
- Being tested
- NOx dressing, Standard of Care
- Keywords
- Nitric oxide, Nitric oxide dressing, NOx, NOx dressing, Diabetic, Foot, Ulcers, Chronic
- Medical subject headings
- Diabetic Foot, Ulcer, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOx dressingDevice
The NOx dressing should be changed at least every 2 days.
Standard of CareOther
The clinician/podiatrist is free to use whichever treatment they would choose to use on the patient in their current clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | NOx dressing applied and changed at least every 2 days for 12 weeks or until ulcer is healed. Receives: Device: NOx dressing |
| Control Arm | Active comparator | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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: Measured at every patient visit until healed or 12 weeks of treatment is reached
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: Samples taken at every visit until 12 weeks or the ulcer is healed
Measure the rate of repeat ulcers and breakdown in healing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edixomed Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Arthur Tucker, PhD, Principal investigator, St Barts, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982565
- Sponsor's protocol ID
- EDX 110
- Acronym
- ProNOx1
- Status last verified
- Jan 2016
- First submitted
- 24 Oct 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pilot Study of an Oxides of Nitrogen Generating Gel Dressing System to Stimulate Healing in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01982565
- Acronym / sponsor ID
- ProNOx1 / EDX 110
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Nitric oxide, Nitric oxide dressing, NOx, NOx dressing, Diabetic, Foot, Ulcers, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Edixomed LtdIndustry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: NOx dressingNOx dressing applied and changed at least every 2 days for 12 weeks or until ulcer is healed. |
| Control Arm | Active comparator | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOx dressingThe NOx dressing should be changed at least every 2 days. | Device | Treatment Arm |
| Standard of CareThe clinician/podiatrist is free to use whichever treatment they would choose to use on the patient in their current clinical practice. | Other | Control Arm |
Primary outcome
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
3 secondary outcomes
Measure changes in ulcer blood flow.
Time frame: 3 months
Measure changes in the inflammatory/infective status of the wounds.
Time frame: Samples taken at every visit until 12 weeks or the ulcer is healed
Measure the rate of repeat ulcers and breakdown in healing.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Tucker, PhD principal investigator
St Barts, London
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NOx dressing in people with Diabetic Foot Ulcer, run by Edixomed Ltd at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.