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 21 years of age or older.
• People who have been diagnosed with Type 1 or Type 2 diabetes.
• People whose wound (ulcer) measures between 1.0 cm² and 5.0 cm² after being cleaned out by a medical professional.
• People whose wound has been present for at least 4 weeks but no longer than 52 weeks before the first screening visit, while receiving standard care.
• People whose wound is located on the foot, with at least half of the wound below the ankle bone.
• People whose wound goes at least through the outer or deeper layers of skin, and may involve muscle, as long as it is below the inner ankle bone — and is classified as Wagner Grade 1 or 2 (confirm with trial site).
• People whose leg has been confirmed to have adequate blood flow, based on one of several accepted blood circulation tests done within the past 3 months (confirm specific test results with trial site).
• People with more than one wound on the foot, where the wounds are at least 2 cm apart after cleaning — the largest wound that meets all the criteria would be chosen for the study.
• People whose wound is on the bottom of the foot and has been kept off the ground (offloaded) for at least 14 days before joining the trial.
• People who are willing to use the prescribed pressure-relief method (such as a special boot or cast) for the entire duration of the study.
• People who are able to attend weekly study visits as required.
• People who are willing and able to go through the informed consent process.

Who may not be able to join:

• People whose life expectancy is expected to be less than 6 months.
• People whose wound is not caused by diabetes.
• People whose wound is infected, requires antibiotic treatment taken by mouth or injection, or has a skin infection (redness and swelling) around it.
• People whose wound has exposed tendon or bone.
• People who show signs of bone infection (osteomyelitis) near the wound.
• People who are taking medications that suppress the immune system (including steroid tablets at higher doses), chemotherapy, or other medications that the lead doctor believes may interfere with wound healing (such as certain biologic treatments).
• People who are taking a medication called hydroxyurea.
• People who have applied steroid creams or ointments directly to the wound within one month before the first screening visit.
• People who have had a partial foot amputation on the affected foot that causes a shape change making it hard to properly offload the wound.
• People whose blood sugar control measure (HbA1c) was 12% or higher within 3 months of the first screening visit.
• People whose wound shrank in size by more than 20% in the 2 weeks before the first screening visit.
• People whose wound shrinks by 20% or more during the 2-week active screening period between the first and second screening visits.
• People who have an active or inactive Charcot foot condition that makes it hard to properly offload the wound (confirm with trial site).
• People who are pregnant or planning to become pregnant within the next 6 months.

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