Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-14

Study Completion Date

2022-09-30

Brief Summary

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This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.

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Detailed Description

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Conditions

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Non Healing Diabetic Foot Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARM 1

Patients receive standard of care treatment for their diabetic foot ulcer

No interventions assigned to this group

ARM 2

Patients receive MolecuLight i:X guided treatment for their diabetic foot ulcer

MolecuLight i:X Imaging Device

Intervention Type DEVICE

The MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.

Interventions

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MolecuLight i:X Imaging Device

The MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients presenting with chronic DFU
* The chronic DFU has a surface area that has reduced \<25% in the previous 4 weeks1 prior to first study visit
* Patient has been receiving treatment for their DFU for less than 12 weeks.
* The chronic DFU is \> 1 cm2 in area and less than 15 cm in length (max. diameter)
* 18 years or older
* Willing and able to make all required study visits

Exclusion Criteria

* • Patients categorized as having a maintenance wound

* Use of skin substitutes or hyperbaric oxygen therapy or surgical intervention
* Treatment with an investigational drug within 1 month of enrolment
* Presents with chronic (\>10 mg/kg for \>30 days) systemic corticoids before enrolment
* Has ABI \<0.5 (measured within 3 months of randomisation)
* Undergoing chemotherapy or is immunocompromised
* Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis
* Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
* Inability or unwillingness to consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No