Phase 1 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 aged 18 years or older
• People who have been diagnosed with type 1 or type 2 diabetes
• People whose foot ulcer has been present for more than 4 weeks but less than 24 weeks at the time of screening
• People whose foot ulcer is located below the ankle bone and measures between 1 and 20 cm² in size at the start of the trial
• People who have adequate blood flow to the affected foot, confirmed by one of three specific circulation tests carried out within the past 60 days (confirm with trial site for which test applies)
• Female participants of childbearing age who test negative on a pregnancy test and agree to use an accepted form of birth control throughout the study
• People whose ulcer reaches into the deeper layers of skin or tissue beneath the skin, but does not expose muscle, tendon, bone, or joint — and where the wound has not shown signs of healing despite standard treatment
• People who are able and willing to wear a special off-loading device or orthopedic shoe to reduce pressure on the foot

Who may not be able to join:

• People who have gangrene anywhere on the affected foot
• People whose ulcer is caused by something other than diabetes
• People whose ulcer is located over a Charcot foot deformity (a specific type of bone and joint damage in the foot)
• People whose ulcer is larger than 20 cm² in total surface area
• People who have a bone infection, skin infection, or other signs of infection in or around the wound
• People who are currently receiving, or have received within the past month, chemotherapy, immunosuppressive drugs, radiation therapy, or corticosteroids (steroid medications)
• People who have AIDS or HIV, or certain heart, thyroid, digestive, neurological, or immune conditions that the study investigator considers would make participation unsuitable
• People whose physical measurements or blood test results fall outside the ranges required by the trial, including blood pressure, heart rate, breathing rate, blood oxygen levels, body temperature, liver enzyme levels, kidney function, platelet count, blood sugar control (HbA1c at or above 8.5%), or haemoglobin levels (confirm specific required ranges with trial site)
• People whose ulcer reaches all the way down to the bone
• People whose ulcer is classified as a more severe wound grade (Wagner Grades 2–6)
• People who have previously had an amputation of the lower leg or foot
• People who have received a skin graft, tissue graft, or cell-based therapy within the past 30 days before screening
• Female participants who are currently pregnant, breastfeeding, or planning to become pregnant during the study
• People who are unwilling or unable to attend the required follow-up visits for data collection
• People who have a known allergy or sensitivity to any components of the study product or its storage medium

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