Phase 3 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 at least 18 years old.
• People who have been diagnosed with diabetes, either currently taking diabetes medication or with two separate blood test results confirming high blood sugar levels (HbA1c over 6.5% and fasting glucose over 126 mg/dL, taken at least one week apart).
• People who have at least one foot ulcer (open wound on the foot) that has not healed for at least 4 weeks.
• People whose target foot ulcer falls within a moderate severity range (Grade 1 or Grade 2 on the Wagner scale) and measures between 1.5 cm² and 25 cm² in size.
• People whose foot ulcer is free from dead tissue (necrosis) and signs of infection.
• People who have signed a written consent form agreeing to take part in the trial.
• Male participants who are surgically sterile, abstinent, or committed to using double-barrier contraception during the study and for 30 days after treatment.
• Female participants who are not pregnant, not breastfeeding, and not planning to become pregnant during the study, and who use highly effective contraception (if capable of becoming pregnant) during the study and for at least 30 days after treatment.

Who may not be able to join:

• People who have current evidence of a bone infection (osteomyelitis) in the foot or leg being treated, as confirmed by X-ray, tissue testing, or a probe-to-bone test (those with a fully resolved bone infection elsewhere in the body, treated more than one year ago with no recurrence, may still be considered — confirm with trial site).
• People whose target ulcer has already shrunk by 30% or more during the standard care period before the trial begins.
• People whose target ulcer produces very heavy fluid drainage requiring dressing changes more than three times a day (though people with other heavily draining wounds may still be considered for enrolment — confirm with trial site).
• People with poor nutritional levels, poorly controlled diabetes (HbA1c above 12%), low white blood cell counts, or abnormal liver function, based on blood tests taken within 21 days before joining the trial.
• People who need ongoing treatment with steroids taken throughout the body, immune-suppressing drugs, or chemotherapy.
• People with a known or suspected allergy to any ingredient in the study product.
• People who have had a heart attack, coronary bypass surgery, or certain heart artery procedures within the past 3 months, or a blood vessel procedure in the legs within the past 30 days.
• People with a history of drug misuse or heavy regular alcohol use (more than 4 units per day) within the 6 months before screening.
• People who have tested positive for HIV or have a known history of HIV.
• People who have had a cancer diagnosis within the last 2 years, with the exception of certain non-spreading skin cancers or a localised cervical carcinoma in situ.
• People with an ankle-brachial index (a blood flow measurement in the legs) below 0.8 or above 1.4, indicating poor circulation (confirm with trial site).
• People who have taken part in another clinical drug trial within the 4 weeks before joining this study.
• People whose overall health condition is judged by the treating doctor to make trial participation potentially harmful.

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