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 gender
• People who have been diagnosed with Type 1 or Type 2 Diabetes that is managed with tablets, other diabetes medications, and/or insulin
• People who have had a foot ulcer (wound on the foot related to diabetes) for at least 4 weeks but less than 12 months while receiving standard wound care
• People whose foot ulcer has shown less than 25% improvement in size during the 14 days before the initial screening appointment
• People whose foot ulcer has shown less than 25% improvement in size during the 14 days before being enrolled into the trial
• People whose foot ulcer falls into a specific wound severity category (Wagner grade 1, 2, or 3) with no signs of infection and no exposed bone visible — Wagner grade 3 wounds may be considered if they involved a bone infection that has already been fully treated with intravenous (IV) antibiotics
• People whose foot ulcer measures between 0.7 cm² and 25 cm² at the first treatment visit
• People whose foot ulcer has been treated with offloading therapy (a method to reduce pressure on the wound, such as a special boot or cast) for at least 14 days before enrolling
• People who have adequate blood circulation to the affected foot, confirmed by specific circulation tests within the required timeframes (confirm with trial site)
• People whose foot ulcer shows no signs of infection at the time of screening and enrolment, meeting a specific low-level infection standard (confirm with trial site)
• People whose foot ulcer is free of dead or decaying tissue before treatment begins
• Women of childbearing potential who have a negative pregnancy test before enrolling
• People who are able and willing to follow all trial requirements
• People who have signed a consent form agreeing to take part
• People with more than one foot ulcer, provided each ulcer is at least 2 cm apart from the others

Who may not be able to join:

• People with a life expectancy of less than one year
• People who are unable to follow the trial's treatment requirements
• People who have major uncontrolled health conditions — such as serious heart, kidney, liver, lung, immune system, or blood disorders — that in the doctor's judgement may affect wound healing
• People currently being treated for cancer, or who have a history of cancer or radiation treatment at the wound site
• People with other health conditions that the treating doctor believes could put them at risk during the trial
• People with known reasons they cannot receive acellular matrix products (a type of wound treatment material)
• People currently taking part in another clinical trial involving an experimental drug or device that may affect wound healing
• People who are pregnant or breastfeeding
• People who have used certain immune-suppressing medications — including steroid tablets at doses above 10 mg daily, chemotherapy, or steroid cream applied directly to the ulcer for more than 2 weeks — within the 30 days before enrolling, or who are expected to need these during the trial
• People whose wound has previously been treated with certain advanced wound care materials (including tissue-engineered or scaffold products) within the 30 days before enrolling
• People with a Wagner grade 3 wound that still has an active bone infection being treated with IV antibiotics, or a long-term 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 (HBOT) within 14 days before enrolling
• People who have had blood vessel surgery on the leg with the ulcer within 30 days of the screening phase
• People whose wound the lead doctor suspects may involve abnormal or cancerous tissue

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