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

Completed

Conditions studied: Non Healing Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT04207099

Run by

MolecuLight Inc.

People needed

61

Starts

2020-02-14

Expected to finish

2024-04-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 18 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

Where it is running

• ILD Research Centre — Vista, California, United States
• Northwell Comprehensive Wound Healing Center and Hyperbarics — Lake Success, New York, United States
• SerenaGroup Monroeville — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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