Evaluating Surface Area Reduction Using MolecuLight Imaging Device

Study Overview
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Brief Summary
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12-week single-blind, prospective, randomized, controlled, pilot clinical trial assessing The MolecuLight i:X Imaging Device in chronic wounds. This device guides clinicians to inspect, sample, debride or further evaluate areas within or around a wound where potentially harmful bacteria appear under violet light illumination resulting in better overall care and accelerated surface area reduction compared to current standard care. The study aims to determine if this device aids in the healing of chronic wounds by reduction in size of wound compared to current standard of care.

Detailed Description
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This is a prospective, 12-week, single-blinded, randomized, controlled clinical trial has been designed with two primary objectives needed to inform more comprehensive studies at a later date. We propose to evaluate the following two primary outcomes: (1) the ability of the MolecuLight i:X Imaging Device to predict non healing wounds and wounds at risk or infection (control arm) and (2) whether utilization of the MolecuLight i:X Imaging Device in guiding clinicians to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present (treatment arm) increases wound healing rates relative to standard care (control arm) for the treatment of chronic wounds. Both arms will receive standard procedures associated with wound care (e.g., sampling, debridement, preventative care, infection control, etc.) according to best practice guidelines. Patients will be randomly assigned to either the control or treatment arm and be followed as per the study protocol every time their wound is cared for over a 12-week period. The effectiveness of the MolecuLight i:X Imaging Device will be assessed with evaluation of wound surface area reduction rate and infection rates (incidence of infection and time to eradicate infection) compared to standard care. All subjects randomized will be evaluated for 12 weeks from the date of enrollment and treatment initiation. Subjects who may have wound closure within the 12-week study period will continue to have scheduled study evaluation visits up to the end of week 12.

Official Title
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A 12-week, Single-blind, Prospective, Randomized, Controlled, Pilot Clinical Trial to Evaluate Surface Area Reduction With Use of the MolecuLight i:X™ Imaging Device Compared to Standard Treatment of Chronic Wounds

Conditions
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Wound, Wound Infection

Intervention / Treatment
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* Device: MolecuLight i:X™ Imaging Device
* Procedure: Wound care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years having a chronic wound that is not a diabetic foot ulcer presence of the wound for ≥ 6 weeks and ≤ 2 years. wound size surface area ≥ 2 cm2 and ≤ 50 cm2. Willingness to comply with prescribed wound care regimen Exclusion Criteria: candidate for surgery in the next 12 weeks a wound with necrotic tissue unable to tolerate debridement uncontrolled diabetics (defined as HbA1c of >85.5mmol/mol) presence of a diabetic foot ulcer currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion) women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control participation in another investigative drug or device trial currently or within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a single blinded randomised trial where the control group will be receiving a standard wound care whereas the treatment group would also be receiving standard wound care but under the guidance of the imaging device.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>This arm group (control) will receive standard wound care of chronic wounds | Procedure: Wound care<br>* Standard wound care of chronic wounds e.g. sampling, debridement, infection control<br>|
| Other: Treatment<br>The treatment arm of the study will utilize the MolecuLight i:X Imaging Device to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present | Device: MolecuLight i:X™ Imaging Device<br>* Offers real-time detection of important biological and molecular information of a wound. The MolecuLight i:X Imaging Device is intended to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device can capture and document either an image or video of the wound where the presence of fluorescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound measurements at various time-points through the study | These measurements will be made using the MolecuLight quickSize measurement tool, which will be loaded onto the i:X device. Wound measurements will be made after any wound cleaning and/or debridement, as per standard practice. | At baseline, 2nd, 4th, 6th, 8th, 10th and 12th week of the study | 
| Change in wound characteristics at various time-points through the study | Wound characteristics will be noted using the Bates-Jensen Wound Assessment score tool | at baseline, 2, 4, 6, 8, 10 and 12 weeks |