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

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 weeks1prior 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 beforeenrolment
• 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 radiationburns, or presents with collagen vascular disease, ulcer malignancy, untreatedosteomyelitis or cellulitis
• Recombinant or autologous growth factors or skin/dermal substitutes within 30days of enrollment
• Inability or unwillingness to consent