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 and use insulin or other diabetes medications (taken by mouth or injection) to manage their blood sugar.
• People whose HbA1c (a blood test that shows average blood sugar levels over several months) is below 12%. A test result from within the past 12 weeks may be accepted.
• People whose foot ulcer has been present for at least 4 weeks but no longer than 1 year, and has not improved with standard wound care.
• People whose ulcer measures between 1.5 cm² and 20 cm² in size, and has a clean, healing-type wound base with very little dead tissue present at the start of the study.
• People whose ulcer is located at or below the ankle bone.
• People who are willing to use special footwear or devices to take pressure off the foot (if the ulcer is on the sole of the foot).
• People whose ulcer goes through all layers of skin but does not reach muscle, tendon, or bone.
• People who have had a procedure to restore blood flow to the lower leg or foot, and that procedure was done at least 12 weeks before joining the study (if applicable).
• People who are in generally good health, with no serious medical conditions that, in the trial doctor's opinion, would affect study participation or safety.
• People who have enough blood circulation to the affected foot, as confirmed by one of several standard circulation tests within the past 12 weeks (confirm with trial site for which test applies).
• People who are willing to use an acceptable form of contraception for the entire duration of the trial, if there is any possibility of pregnancy. Acceptable methods include abstinence, hormonal contraception used together with a barrier method, or an implanted contraceptive device. Male participants (who have not been sterilised) with a female partner who could become pregnant must agree to use a condom throughout the study and must not donate sperm during this time.
• People who are able to read, understand, and sign a consent form.
• People who are able to attend all study visits and follow the study's wound care requirements, such as wound cleaning and dressing changes.

Who may not be able to join:

• People who have signs of an active wound infection or who are currently using antibiotic or antimicrobial treatments (by injection, mouth, or applied to the skin).
• People who use a wheelchair full-time or are confined to bed. (Being able to walk with some assistance is acceptable.)
• People whose ulcer is located at the site of a previous amputation.
• People who are currently receiving kidney dialysis.
• People who have a known or suspected cancer in or near the ulcer, or who have had cancer in the past 5 years. (Certain early-stage cervical conditions or previously treated non-melanoma skin cancers may not automatically exclude participation — confirm with trial site.)
• People who have a documented history of bone infection (osteomyelitis) at the ulcer site within the past 6 months.
• People who have previously had radiation treatment at the ulcer site.
• People with moderate to severe heart failure (classified as New York Heart Association Class III or IV) or an uncontrolled irregular heartbeat.
• People who have been diagnosed with an autoimmune condition such as rheumatoid arthritis, lupus, psoriasis, or Sjögren's syndrome, or any form of arthritis that requires steroid medication as treatment.
• People who have used, or are expected to use during the study, any of the following treatments in the past 4 weeks: immune-suppressing medications (including long-term steroid tablets or steroid creams applied directly to the ulcer), chemotherapy, growth hormone, antifungal or tuberculosis medications taken by mouth or systemically, or any other experimental drug or medical device.
• People whose ulcer has been treated in the past 4 weeks with negative pressure wound therapy, hyperbaric oxygen (pressurised oxygen therapy), or certain skin substitute or scaffold products (confirm with trial site for specific product names).
• People whose ulcer is expected to need negative pressure wound therapy or hyperbaric oxygen at any point during the study.
• People whose ulcer showed healing of 35% or more during the lead-in period before the study officially begins.
• People who are pregnant or breastfeeding.
• People with any other condition that would seriously affect their ability to complete the study, or who have a known history of not following through with medical treatment.
• People with an active Charcot foot condition. (A stable, longstanding Charcot foot may not prevent participation — confirm with trial site.)
• People whose ulcer is located only on the smaller toes (toes 2, 3, 4, and/or 5). (An ulcer on the sole of the big toe alone may still be eligible — confirm with trial site.)

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