Phase 4 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:

• You are 18 years of age or older (note: the trial aims for at least half of participants to be over 65)
• You have been diagnosed with Type 1 or Type 2 Diabetes and are being treated by a doctor with pills and/or insulin
• You have a diabetic foot ulcer of a certain severity level (called Wagner Grade 1 or 2) located on any part of the foot at or below the ankle bone
• Your foot ulcer has been present for more than 4 weeks but less than 12 months, and you have been receiving standard wound care treatment
• Your wound has shown less than 20% improvement in size during the two-week check-in period before the trial begins
• Your wound measures between 1.0 cm² and 25 cm² after being cleaned out by a medical professional
• Any previous infection in the wound or leg has been fully treated and is under control
• You have adequate blood flow to the affected foot, confirmed by specific circulation tests done within the last 3 months (confirm with trial site)
• You are willing and able to follow all the study requirements
• You have signed a consent form agreeing to participate
• You have been using a specific pressure-relieving device on the wound for at least 14 days before the trial officially starts
• Your wound has a clean base with no dead tissue at the time treatment begins
• If you are a woman who could become pregnant, you have tested negative for pregnancy and are willing to use an acceptable form of contraception throughout the study

Who may not be able to join:

• You have a life expectancy of less than one year
• Your foot ulcer has been present for more than one year
• Your wound has already improved by 20% or more in size during the two-week check-in period before the trial starts
• You are unable to use the required pressure-relieving device for your wound
• You have conditions that would make it very difficult to complete the study or you have a history of not following through with medical treatment
• Your wound is completely covered in dead or hardened tissue
• You have serious uncontrolled health conditions such as heart disease, kidney disease, liver disease, lung disease, lupus, or sickle cell anemia, or are receiving palliative (end-of-life comfort) care
• You are currently being treated for cancer, or have a history of cancer within the wound itself
• You have other health conditions that the lead doctor feels could put you at risk during the study (confirm with trial site)
• You have a known allergy or sensitivity to amniotic tissue products or any ingredient in the specific treatment used in this trial (called Amnio-Maxx)
• You are currently taking part in another clinical trial involving an experimental drug or device that could affect this study
• You are pregnant or breastfeeding
• You have taken immune-suppressing medications, certain chemotherapy drugs, or steroid creams on the wound for more than two weeks within the 30 days before the trial starts, or are expected to need these during the study (confirm with trial site)
• Your wound has been treated in the last 30 days with certain advanced wound care materials such as Apligraf®, Dermagraft®, Oasis, or Matristem

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