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 who are 18 years of age or older.
• People who have been diagnosed with Type 1 or Type 2 diabetes.
• People who have a diabetic foot wound (ulcer) that, after cleaning, measures between 1.0 cm² and 10.0 cm² in size at the time of joining the trial.
• People whose foot wound has been present for at least 4 weeks but no longer than 52 weeks before the first screening visit.
• People whose wound is located on the foot, with at least half of the wound below the ankle bone.
• People whose wound goes through all layers of skin but does not reach the bone.
• People who have adequate blood flow to the affected foot, confirmed by one of several medical tests performed within 3 months of the first screening visit (confirm with trial site for which tests qualify).
• People who have more than one foot ulcer, provided the ulcers are at least 2 cm apart — the largest qualifying ulcer would be selected for the trial.
• People whose wound is on the sole of the foot and who have been using a prescribed pressure-relieving device (such as a special boot or cast) for at least 14 days before joining the trial.
• People who agree to continue using a prescribed pressure-relieving method for the entire duration of the study.
• People who are able and willing to attend weekly study visits as required.
• People who are able and willing to take part in the informed consent process.

Who may not be able to join:

• People with a life expectancy of less than 6 months.
• People whose target wound is currently infected, or who have a skin infection (cellulitis) around the wound.
• People who have a bone infection (osteomyelitis), exposed bone, or where probing or imaging shows the wound reaches the bone or joint.
• People whose wound or limb has had a previous infection that has not been fully treated and controlled.
• People currently taking immune-suppressing medications or chemotherapy drugs — including steroid medications at doses higher than 10 mg of Prednisone per day (or an equivalent dose of another steroid).
• People who have applied steroid cream or ointment directly to the wound within one month before the first screening visit.
• People who have had a partial amputation on the affected foot, if the resulting change in foot shape makes it difficult to properly relieve pressure on the wound.
• People whose blood sugar control measurement (HbA1c) is 12% or higher, taken at or within 3 months of the first screening visit.
• People whose kidney function blood test (serum creatinine) is 3.0 mg/dL or higher within 6 months of joining the trial.
• People whose wound has shrunk in size by more than 30% during the 2-week screening period before the trial begins.
• People with an active or inactive Charcot foot condition (a serious foot deformity related to nerve damage) that makes it difficult to properly relieve pressure on the wound.
• People who are pregnant or planning to become pregnant within the next 6 months.
• People with end-stage kidney disease who require dialysis.
• People who, in the opinion of the investigating doctor, have a medical or psychological condition that may interfere with the study.
• People who have received hyperbaric oxygen therapy or a specialised wound tissue product within 30 days before the first screening visit.

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