Ulcer FootNCT03270904
Moleculight i:X™ in Wound Healing
A study testing Moleculight i:X™ fluorescence imaging in people with Ulcer Foot, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ulcer Foot
- What is being tested?
- Moleculight i:X™ fluorescence imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to 31 Aug 2018
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Diagnosis of Diabetes (according to WHO criteria)
- Has ulceration of the foot below the malleoli
- Expected to comply with the treatment strategies and follow up schedule
- Consent to foot and wound photography
- Consent to participate (written/witnessed verbal consent)
Who cannot join
- Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).
- Estimated glomerular filtration rate (eGFR) <20mL/min/1.73m2 (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred)
- Has ABPI <0.5 or opening toe pressure <30mmHg (measured within 3 months of randomisation)
- Planned or previous treatment with corticosteroids to an equivalent dose of Prednisolone >10mg per day or other immunosuppressive therapy within 4 weeks prior to randomisation
- Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment.
- Has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis bullosa)
- Has previously been randomised to the Moleculight i:X™ study
- Lacks mental capacity and is unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
About this study
Official title: The Use of Moleculight i:X™ in the Management of Diabetic Foot Ulcers: A Pilot Study
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15.
A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection.
Read more
This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
- Conditions
- Ulcer Foot
- Being tested
- Moleculight i:X™ fluorescence imaging
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moleculight i:X™ fluorescence imagingDevice
Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Interventional Treatment | Experimental | Participants in this group have been randomised to receive application of violet blue light administered by the hand held Microlight i:X device in addition to routine care of their foot ulcer. This intervention will be administered four times during the study. Receives: Device: Moleculight i:X™ fluorescence imaging |
| Group 2 - Usual care | No intervention | This group receive routine care and no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of diabetic foot ulcers healed at 12 weeks post randomisation
The proportion of diabetic foot ulcers which have healed in both group 1 and group 2 at 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Dec 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcer FootStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270904
- Sponsor's protocol ID
- VS17/99990
- Status last verified
- Jan 2018
- First submitted
- 31 Aug 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahma S, Woods J, Brown S, Nixon J, Russell D. The Use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1601-1609. doi: 10.2337/dc21-2218.
PubMed 35796769
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Moleculight i:X™ in the Management of Diabetic Foot Ulcers: A Pilot Study
- ClinicalTrials.gov ID
- NCT03270904
- Acronym / sponsor ID
- VS17/99990
- Conditions
- Ulcer Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- 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.
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15.
A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection.
This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Interventional Treatment | Experimental | Device: Moleculight i:X™ fluorescence imagingParticipants in this group have been randomised to receive application of violet blue light administered by the hand held Microlight i:X device in addition to routine care of their foot ulcer. This intervention will be administered four times during the study. |
| Group 2 - Usual care | No intervention | –This group receive routine care and no additional intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years
- Diagnosis of Diabetes (according to WHO criteria)
- Has ulceration of the foot below the malleoli
- Expected to comply with the treatment strategies and follow up schedule
- Consent to foot and wound photography
Key exclusion criteria (8 listed)
- Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).
- Estimated glomerular filtration rate (eGFR) <20mL/min/1.73m2 (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred)
- Has ABPI <0.5 or opening toe pressure <30mmHg (measured within 3 months of randomisation)
- Planned or previous treatment with corticosteroids to an equivalent dose of Prednisolone >10mg per day or other immunosuppressive therapy within 4 weeks prior to randomisation
- Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment.
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 |
|---|---|---|
| Moleculight i:X™ fluorescence imagingMoleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall. | Device | Group 1 - Interventional Treatment |
Primary outcome
The proportion of diabetic foot ulcers healed at 12 weeks post randomisation
Time frame: 12 weeks
The proportion of diabetic foot ulcers which have healed in both group 1 and group 2 at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Derived from this study: PubMed 35796769Rahma S, Woods J, Brown S, Nixon J, Russell D. The Use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1601-1609. doi: 10.2337/dc21-2218.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moleculight i:X™ fluorescence imaging in people with Ulcer Foot, run by The Leeds Teaching Hospitals NHS Trust at 1 site 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Russell, MB ChB, MD (+44 113 243 2799, davidrussell1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of diabetic foot ulcers healed at 12 weeks post randomisation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270904, which also lists 1 linked publication.
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 24 Jan 2018.