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:

• Adults aged 18 or older, of any sex
• People who have been diagnosed with Type 1 or Type 2 Diabetes and are managing it with tablets, other diabetes medications, or insulin
• People who have had a diabetic foot ulcer for at least 4 weeks but less than 12 months while receiving standard wound care
• People whose foot ulcer has shown less than 25% healing in the 14 days before the initial screening visit
• People whose foot ulcer has shown less than 25% healing in the 14 days before being enrolled into the trial
• People whose foot ulcer falls within a specific severity range (Wagner grade 1, 2, or 3) and shows no signs of infection or exposed bone — a grade 3 ulcer involving bone infection may still be considered if a full course of intravenous antibiotic treatment has already been completed
• People whose ulcer measures between 0.5 cm² and 25 cm² at the first treatment visit
• People who have been using pressure-relieving footwear or devices (offloading therapy) for at least 14 days before being enrolled
• People whose blood flow to the affected foot has been assessed and confirmed as adequate through specific circulation tests within the required timeframes (confirm with trial site)
• People whose ulcer is free of infection and dead tissue before treatment begins
• Women who could become pregnant must have a negative pregnancy test before being enrolled
• People who are willing and able to follow all study requirements
• People who have signed a consent form agreeing to take part
• People with more than one ulcer, where each ulcer is separated by at least 2 cm

Who may not be able to join:

• People with a life expectancy of less than one year
• People who are unable to follow the study treatment plan
• People with serious uncontrolled health conditions — such as heart, kidney, liver, lung, immune system, or blood disorders — that the study doctor believes may affect wound healing
• People currently being treated for cancer, or who have a history of cancer or radiation therapy at the wound site
• People with other health conditions that the study doctor believes may put them at risk during the trial
• People with known reasons why a tissue-based skin graft product should not be used (confirm with trial site)
• People currently taking part in another clinical trial involving an experimental drug or device that could affect wound healing
• People who are pregnant or breastfeeding
• People who have used certain immune-suppressing treatments (including steroid tablets at higher doses, chemotherapy, or steroid creams applied to the ulcer for more than 2 weeks) within the 30 days before enrolment, or who are expected to need these during the study
• People whose wound has already been treated with certain advanced skin or tissue products within the 30 days before enrolment
• People with a grade 3 ulcer involving active bone infection that has not yet completed intravenous antibiotic treatment, or a long-standing bone infection that has not responded to treatment
• People whose wound is deep enough that bone is visibly exposed
• People who have received hyperbaric oxygen therapy within 14 days before enrolment
• People who have had blood vessel surgery on the affected leg within 30 days of the screening visit
• People whose ulcer is suspected by the study doctor to involve abnormal or potentially cancerous tissue

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