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:

• People aged 22 to 90 years old, of any gender
• Women who are able to become pregnant must be willing to use an accepted form of contraception (such as birth control pills, barrier methods, or abstinence) from the start of the trial and throughout their involvement
• The person joining the trial (or their legal representative, if needed) must be able to understand and sign a consent form, and must be willing to follow all trial requirements, including scheduled visits, treatments, wound dressing routines, and using any required offloading device (such as a special boot or cast)
• People who have been diagnosed with Type 1 or Type 2 diabetes
• People who have at least one diabetic foot ulcer (open wound on the foot or ankle area) that goes through the full thickness of the skin — if more than one wound qualifies, the trial doctor will select one as the focus of treatment
• The wound must be classified as Wagner Grade 1 or 2, meaning it does not involve exposed bone
• The target wound must be at least 2 cm away from any other wound on the same foot (measured after wound cleaning)
• The target wound must have been present for more than 30 days but less than 52 weeks (one year)
• The target wound must measure between 0.5 and 25 cm² in size at the screening visit (and at least 0.5 cm² after wound cleaning at the start of the run-in phase)
• The leg with the wound must have adequate blood flow, confirmed by one of several blood flow tests showing results within the acceptable ranges set by the trial (confirm specific measurements with the trial site)

Who may not be able to join:

• People who are pregnant or breastfeeding
• People with active skin cancer, a history of skin cancer or other localised cancer, precancerous skin lesions, or large moles in the area to be treated
• People taking medications that the trial doctor believes may interfere with wound healing
• People currently being treated for an active infection throughout the body, including bone infection (osteomyelitis)
• People whose wound is classified as Wagner Grade 3, 4, or 5 (more severe wounds)
• People who have taken part in another clinical trial involving an experimental drug or medical device within the 30 days before this trial, or who are currently in another trial
• People with other serious medical conditions that the trial doctor considers would put them at unreasonable risk
• People with advanced kidney disease requiring dialysis
• People taking high-dose steroid medications (such as prednisone or similar) — specifically more than 10 mg per day for over 10 days, or any dose for more than 30 days
• People whose wound shows too much improvement during the run-in phase before the trial formally begins (specific wound-closure thresholds apply — confirm details with the trial site)
• People whose blood test results fall outside the acceptable ranges for this trial, including markers related to nutrition, kidney function, blood cell counts, and blood sugar control (confirm specific values with the trial site)

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