Moleculight i:X™ in Wound Healing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03270904|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : January 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcer Foot||Device: Moleculight i:X™ fluorescence imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Moleculight i:X™ in the Management of Diabetic Foot Ulcers: A Pilot Study|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||August 31, 2018|
Experimental: Group 1 - Interventional Treatment
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.
Device: Moleculight i:X™ fluorescence imaging
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.
No Intervention: Group 2 - Usual care
This group receive routine care and no additional intervention.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270904
|Contact: David Russell, MB ChB, MD||+44 113 243 email@example.com|
|Leeds Teaching Hospitals NHS Trust||Recruiting|
|Leeds, United Kingdom|