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

NCT04207099 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-09-29

No results posted yet for this study

Summary

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.

Conditions

  • Non Healing Diabetic Foot Ulcer

Interventions

DEVICE

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.

Sponsors & Collaborators

  • MolecuLight Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207099 on ClinicalTrials.gov