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 male or female and between 21 and 80 years old at the time of signing the consent form
• You have been diagnosed with Type 1 or Type 2 diabetes and have been on a stable diabetes treatment for at least 30 days before your first study visit
• You have a wound that goes through all layers of skin on the lower part of your leg, below the ankle
• You have only one wound being considered for this study
• Your wound measures at least 1 cm² but less than 25 cm² in size, and is no deeper than 9 mm
• Your diabetic foot wound has been present for at least 30 days and is classified as a Grade 1 (affects full skin thickness only) or Grade 2 (reaches deeper tissues like tendons or ligaments, but has no infection in the bone or pus pockets)
• Your wound shows no signs of infection at both of your early study visits
• You have enough blood flow to the affected foot, confirmed by at least one of several circulation tests done within the past 60 days (confirm with trial site)
• You are able and willing to use a special boot or device to take pressure off your wound, and to follow the wound dressing schedule
• You understand what the study involves, are willing to sign a consent form, and agree to follow the study rules and attend all required visits
• You have agreed in writing to allow the study team to use your health information as required
• Your doctors expect you to live for more than 6 months

Who may not be able to join:

• You are pregnant or currently breastfeeding
• Your wound is less than 30 days old and has already shrunk by 50% or more between your first and second study visits
• Your HbA1c blood sugar level (a measure of long-term blood sugar control) was above 12% in the 90 days before screening (confirm with trial site for timing of tests)
• A recent blood test shows your kidneys may not be working well enough (specifically, a creatinine level of 3.0 mg/dL or higher within 30 days before screening) (confirm with trial site)
• You are allergic or sensitive to any of these antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
• You are sensitive to any of these ingredients: polysorbate 20, N-lauroyl sarcosinate, benzonase, or glycerol
• Your wound has been treated with growth factor products (biological or topical) in the 30 days before screening
• You need a wound dressing that is not approved for use in this study
• Your wound shows visible signs of infection at either of your early study visits
• You are unable to wear an off-loading boot (a special boot used to protect the wound)
• You have a known or suspected condition that affects your immune system
• You have an active cancer or an uncontrolled connective tissue disease (such as lupus or rheumatoid arthritis)
• You have received immunosuppressant drugs, chemotherapy, radiation therapy, or systemic steroid medicines within 30 days before your baseline visit
• Your wound has dead tissue, pus, or tunnels beneath the skin that cannot be fully cleaned out
• You have had a procedure to improve blood flow to the affected leg within 4 weeks before your baseline visit
• Recent blood tests show that your liver function values are more than three times the normal level (confirm with trial site for timing of tests)
• You have active Charcot disease (a serious condition affecting the bones and joints of the foot)
• You have been treated with a living skin product on your wound within the 4 weeks before screening
• You have signs of poor circulation in your feet, including more than one pulse that cannot be felt in either foot
• Your doctor believes that joining the study would put you at risk or could affect the quality of the study results

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