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

MolecuLight

Status

Unknown

Conditions

Non Healing Diabetic Foot Ulcer

Treatments

Device: MolecuLight i:X Imaging Device

Study type

Observational

Funder types

Industry

Identifiers

NCT04207099

18-014

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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