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

• Conditions: Non Healing Diabetic Foot Ulcer

• Registration Number: NCT04207099
• Lead Sponsor: MolecuLight Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Study Start: 2020-02-14
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1	5 months	ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period

Secondary Outcome Measures

Name	Time	Method
Wound Healing Rate	5 months	ARM 1 vs. ARM 2; 1. Evaluate increase in wound healing rate over 12-week period; 2. Evaluate differences in clinical infection i. time to eradicate an infection ii. incidence of new infection (i.e. infection avoidance); 3. 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.

Trial Locations

Locations (2)

ILD Research Centre; 🇺🇸 Vista, California, United States

Northwell Comprehensive Wound Healing Center and Hyperbarics; 🇺🇸 Lake Success, New York, United States