Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the 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 or older who have been diagnosed with Type 1 or Type 2 diabetes and are being treated with tablets or insulin
• People who have a diabetic foot ulcer that has been present for more than 4 weeks but less than 12 months, and is currently being treated with standard wound care
• People whose wound has not reduced in size by 25% or more during the two-week screening period before the study starts
• People whose wound measures between 1.0 cm² and 25 cm² after wound cleaning at the first treatment visit
• People whose foot ulcer is graded as Wagner Grade 1 or 2 (a mild to moderate ulcer), located on any part of the foot where at least half of the wound sits below the ankle bone
• People whose wound is free of dead tissue and has a clean base at the time treatment is applied
• People who have adequate blood flow to the affected foot, confirmed by specific circulation tests within the past 3 months (confirm with trial site)
• People whose ulcer has been kept offloaded using a prescribed device for at least 14 days before the study begins
• Women of childbearing age who have a negative pregnancy test and are willing to use an accepted form of contraception throughout the study
• People who are able and willing to follow all study requirements and have provided signed informed consent

Who may not be able to join:

• People with a known life expectancy of less than one year
• People whose foot ulcer has been present for more than one year
• People who are unable to use or comply with an offloading device (a device that takes pressure off the wound)
• People whose ulcer is completely covered in dead or fibrous tissue
• People with major uncontrolled health conditions such as serious heart, kidney, liver, or lung disease, lupus, sickle cell anaemia, or those receiving palliative care
• People currently being treated for cancer, or who have a history of cancer within the ulcer itself
• People with known allergies to acellular dermal matrices or any component of the Miro3D product used in this trial
• People currently taking part in another clinical trial involving an investigational drug or device that could interfere with this study
• People whose wound has already reduced in size by 25% or more during the two-week screening period
• People who are pregnant or breastfeeding
• People who have used immunosuppressant medications, high-dose systemic steroids (more than 10 mg daily), chemotherapy, or topical steroids on the wound for more than two weeks within the 30 days before the study starts
• People whose ulcer has been treated with certain skin or tissue products (such as Apligraf, Dermagraft, Oasis, or similar materials) within the 30 days before the first treatment visit
• People who require hyperbaric oxygen therapy during the trial or within two weeks of the first screening visit
• People whose diabetes is poorly controlled, shown by a blood sugar marker (HbA1c) of 12.0% or higher within 30 days of joining the study
• People who have gangrene or unstable poor circulation in the affected limb or ulcer at the time of screening
• People who have had blood vessel surgery on the leg where the ulcer is located within 30 days of the screening visit
• People whose ulcer the study doctor suspects may be cancerous
• People with any other health finding that the study doctor believes could put them at risk or affect the study

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