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 medically diagnosed with Type 1 or Type 2 Diabetes and are managing it with tablets, other blood sugar medications, or insulin, and who also have a diabetic foot ulcer
• People whose foot ulcer has been classified at a specific severity level (Wagner grade 1, 2, or 3) with no infection or visible bone. A grade 3 ulcer may be acceptable if it involved a bone infection that has already been fully treated with intravenous (IV) antibiotics before the screening visit
• People whose ulcer measures between 0.5 cm² and 25 cm² at the first treatment visit
• People who are willing and able to follow all the requirements of the trial
• People who have signed a consent form agreeing to take part
• People whose blood flow to the affected limb has been confirmed as adequate through specific circulation tests within the required timeframes (confirm with trial site)
• People whose foot ulcer has been treated with a total contact cast or an approved fixed ankle walker boot for at least 7 days before the first treatment visit
• People whose wound has no signs of active infection (no pus, no spreading skin infection, no bone infection) after wound cleaning
• People who have had a blood sugar (HbA1c) test recorded within 90 days before the first treatment visit

Who may not be able to join:

• People who are unable to follow the trial treatment plan
• People whose grade 3 ulcer involves a bone infection that has not been fully treated with 6 weeks of IV antibiotics, or where the bone infection is classified as long-term and difficult to treat
• People whose ulcer is classified as Wagner grade 3, 4, or 5 and involves tendons, bone, or joints
• People who have a widespread or serious infection, blood poisoning, or active bone infection at the time of screening
• People who have more than one diabetic foot ulcer on the same foot, where the ulcers are less than 2 cm apart from the main ulcer being studied
• People who have serious uncontrolled medical conditions — such as significant heart, kidney, liver, lung, immune system, or blood disorders — that the doctor believes may affect wound healing
• People who are currently being treated for cancer, or who have a history of cancer or radiation treatment at the wound site
• People who have other health conditions that the doctor believes could put them at risk during the trial
• People who have a known allergy or sensitivity to amniotic membrane products or to the components of the study treatment (NeoThelium FT)
• People who are currently taking part in another clinical trial involving an investigational drug or tissue product that could interfere with wound treatment or healing
• People who are pregnant or breastfeeding
• People who have used high-dose steroid tablets (more than 10 mg daily), chemotherapy, or steroid creams applied directly to the ulcer for more than 2 weeks — within 30 days before the first treatment visit — or who are expected to use these during the trial
• People whose wound has previously been treated with certain advanced wound products, tissue-engineered materials, or scaffold materials within 30 days before enrolling (confirm with trial site)
• People whose ulcer is suspected by the doctor to involve abnormal or potentially cancerous tissue

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