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

A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone

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.

Study Overview

• Status: Recruiting
• Conditions: Non Healing Diabetic Foot Ulcer
• Intervention / Treatment: Device: MolecuLight i:X Imaging Device

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Liis Teene; Phone Number: 416.542.5530; Email: lteene@moleculight.com
• Study Contact Backup: Name: Divya Bhardwaj; Phone Number: 416.542.5531; Email: divyab@moleculight.com

Study Locations

• United States
  • California
    • Vista, California, United States, 92083
      • Recruiting
      • ILD Research Centre
      • Contact: Eric Martinez; Phone Number: 6 760-350-5080; Email: eric@ildresearch.com
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Comprehensive Wound Healing Center and Hyperbarics
      • Contact: Sally Kaplan, RN; Phone Number: 516-562-4578; Email: skaplan2@northwell.edu
      • Contact: Farisha Baksh; Phone Number: 516-233-3629; Email: Fbaksh@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female subjects presenting with non healing diabetic foot ulcer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Rate	ARM 1 vs. ARM 2; Evaluate increase in wound healing rate over 12-week period; Evaluate differences in clinical infection i. time to eradicate an infection ii. incidence of new infection (i.e. infection avoidance); Determine if MolecuLight i:X images taken at baseline can predict non-healing wounds, region for debridement and/or wounds at risk of infection (based on fluorescent signatures) at 6 and 12 weeks.	5 months

Collaborators and Investigators

• Sponsor: MolecuLight Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 18-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No