Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 75 years old
• You have been diagnosed with either type 1 or type 2 diabetes
• Your recent blood sugar control measure (called A1C) is 10 or below, based on a test taken within the last 2 months
• Your body mass index (a measure of body weight relative to height) is 36 or below
• You have a diabetic foot ulcer (wound on the foot) of a specific moderate severity, and after wound cleaning, the wound measures between 1.0 and 8.0 square centimetres
• Your foot wound has been present for between 4 and 52 weeks
• Your foot wound is located at least 1 centimetre below the ankle bone
• Tests show that blood is flowing adequately to your foot (confirm with trial site)
• If you have a wound on the sole of your foot, you must have been using an offloading device (something to take pressure off the wound) for at least 14 days before starting treatment
• You are able to give your consent to take part and attend all required appointments
• If you are a woman who could become pregnant, you must meet the trial's contraception requirements (confirm with trial site)

Who may not be able to join:

• Your foot wound is currently infected, or the skin around it is infected
• Your wound is caused by poor blood supply, or you have a bone infection or exposed bone
• You have recently needed antibiotics for an active infection (you may become eligible after the infection clears and a 7-day waiting period has passed)
• You have an active or unstable Charcot foot condition that prevents you from using an offloading device
• Your haemoglobin (a measure of red blood cells) is below 10 g/dL, unless the trial sponsor gives special approval
• You have severe kidney disease that requires dialysis
• You have had or are planning to have a blood vessel procedure on the affected leg within 30 days of the trial
• You have taken part in another clinical trial involving an investigational treatment within the last 30 days
• You have had an active problem with alcohol or substance misuse within the last 3 months
• You are currently pregnant or breastfeeding
• The trial doctor has identified other reasons that may make participation unsuitable (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.