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

NCT04207099 | Unknown FDA Device

• 1 other identifier: 18-014
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1

  ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period

  5 months

Secondary Outcomes (1)

• Wound Healing Rate

  5 months

Study Arms (2)

ARM 1

Patients receive standard of care treatment for their diabetic foot ulcer

ARM 2

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

Device: MolecuLight i:X Imaging Device

Interventions

MolecuLight i:X Imaging Device 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.

ARM 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female subjects presenting with non healing diabetic foot ulcer

You may qualify if:

• 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)
• years or older
• Willing and able to make all required study visits

You may not qualify if:

• 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

Sponsors & Collaborators

• MolecuLight Inc.: lead

Study Sites (2)

ILD Research Centre

Vista, California, 92083, United States

RECRUITING

Northwell Comprehensive Wound Healing Center and Hyperbarics

Lake Success, New York, 11042, United States

RECRUITING

Central Study Contacts

Liis Teene

CONTACT

416.542.5530; lteene@moleculight.com

Divya Bhardwaj

CONTACT

416.542.5531; divyab@moleculight.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 20, 2019
• Study Start: February 14, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

US (2)