Completed

NCT Number: NCT04207099

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

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.

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Key information

Conditions

Non Healing Diabetic Foot Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ILD Research Centre, Vista, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 5 months

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

Secondary outcomes

Wound Healing Rate

Time frame: 5 months
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.

Sponsors and collaborators

Lead sponsor

MolecuLight Inc.

Industry

Registry information

Official study title

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

Acronym: WAR

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Dec 20, 2019
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.