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

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

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.

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