Phase 2 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 at least 20 years old
• You (or your legal representative) are able to understand what the study involves and are willing to sign a consent form
• You are willing to follow the wound care routine for the whole study and attend all required visits
• You have been diagnosed with Type 1 or Type 2 diabetes and are currently under a doctor's care for it
• Your HbA1c blood sugar level is 12% or below
• You have at least one diabetic foot ulcer located below the knee that has not been healing for 4 weeks or more despite proper care, measures between 0.5 cm² and 10 cm², is classified as Grade 1 or Grade 2 on the Wagner scale (a standard wound grading system), and shows no signs of infection
• There is enough blood flow to your affected lower leg or foot, shown by specific circulation tests (confirm with trial site)
• Your liver and kidney function are within acceptable levels based on blood tests
• Your blood counts (white blood cells, platelets, red blood cells, etc.) are within acceptable ranges
• If you are a woman, you have a negative pregnancy test within 28 days before the first treatment
• If you are a man, or a woman who could become pregnant, you agree to use at least one form of contraception during the study and for at least 4 weeks after finishing treatment

Who may not be able to join:

• Your target wound shows signs of infection (such as swelling, redness, warmth, pain, or discharge)
• You have a serious skin infection (cellulitis) or tissue death (gangrene) on the lower leg or foot with the target wound
• You have a bone infection that requires antibiotics taken by mouth or injection (unless the course of antibiotics was completed at least 1 week before your screening visit)
• Your target wound shrank or grew by 30% or more after 2 weeks of standard wound care before the study begins
• You have another open wound within 2 cm of the target wound on the same leg or foot
• Your target wound was not primarily caused by diabetes
• Your target wound is related to an amputation wound that has not fully healed
• You have a physical deformity of the lower leg or foot that would make it impossible to keep pressure off the wound
• You are scheduled to receive, or have received in the past 4 weeks, certain treatments such as growth factor products, steroids (taken by mouth or injection), immunosuppressants, radiation, chemotherapy, or are currently in another clinical trial
• You have had skin grafts, skin substitute products, or hyperbaric oxygen therapy on the target wound within the past 2 weeks
• You have used topical antibiotics or enzyme-based wound cleaning treatments on the target wound in the past 7 days
• You have a history of cancer or currently have cancer, with some exceptions for certain treated skin or cervical cancers with no signs of return (confirm with trial site)
• You have a condition affecting blood vessels or connective tissue, or another medical condition known to slow wound healing (other than diabetes)
• You have been diagnosed with sickle cell disease
• You have a significant heart rhythm or electrical abnormality on an ECG, as judged by the study doctor
• Your nutritional status is poor, based on a low blood protein (albumin) level
• Your inflammation marker (C-reactive protein) is above a certain level on a blood test
• You have a history of drug or alcohol misuse as defined by standard medical guidelines
• You have tested positive for HIV
• You are currently breastfeeding
• You have a medical, mental, or psychological condition that would make it difficult to follow the study treatment plan, as determined by the study doctor

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