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:

• Adults between 18 and 80 years old at the time of joining the study
• People who have a diabetic foot ulcer (an open wound on the foot related to diabetes) located on the bottom, side, or top of the foot, below the ankle bone
• People who have been diagnosed with Type 1 or Type 2 diabetes, and whose diabetes treatment or diet plan has been stable for at least 30 days (or 6 months for diet-only management of Type 2 diabetes)
• People whose blood sugar control measure (called HbA1c) is at or below 10%, confirmed within the last 30 days or during the screening period
• People who have a single main wound being studied, with any other foot wounds located more than 2 cm away from it
• People whose wound is larger than 1 cm² but smaller than 25 cm², and does not go as deep as the bone
• People whose wound has been present for more than 4 weeks but less than 1 year
• People whose wound shows no signs of infection, confirmed by imaging (such as an X-ray, CT, or MRI scan)
• People who have adequate blood flow to the affected foot, confirmed by one of several circulation tests during the screening period (confirm with trial site for which tests apply)
• People who are able to follow the study's requirements for keeping weight off the wound and changing dressings
• People who have not used any tobacco or nicotine products — including cigarettes, cigars, pipes, vaping, smokeless tobacco, or nicotine patches — for at least 4 weeks before the first treatment
• People who are able to understand the study requirements and provide informed consent
• People with a life expectancy of more than 6 months
• People whose wound has not responded to standard wound care for at least 4 weeks
• People who will not need certain other wound treatments — such as negative pressure therapy, antimicrobial dressings, or hyperbaric oxygen therapy — during the study
• People who have not had radiation treatment at the wound site
• People whose wound has a clean base with no dead tissue or infection at the time of treatment
• People whose wound has been kept offloaded (pressure relieved) using a special boot or cast for at least 14 days after the first screening visit
• Women who could become pregnant must be willing to use an accepted method of contraception throughout the study and undergo pregnancy testing at required points during the study

Who may not be able to join:

• People who are pregnant or breastfeeding
• People under 18 years of age
• People who are currently using tobacco or nicotine products
• People whose wound shrank by 30% or more between the screening visit and the treatment visit
• People whose wound is already showing clear signs of healing on its own (such as new tissue growth or a 30% or greater reduction in wound size)
• People whose HbA1c (blood sugar control measure) is above 10% within 30 days of screening
• People whose kidney function test (creatinine level) is at a level of 3.0 mg/dL or higher within 30 days before screening
• People whose wound was treated with biological or growth-factor-based products within the 30 days before screening
• People who require wound dressing materials not approved for use in this study
• People who have a bone infection in the affected foot, confirmed by imaging within 30 days before the first screening visit
• People who are unable to use offloading devices such as a surgical shoe, removable cast, or total contact cast
• People who have a known or suspected immune system disorder
• People who have an active or untreated cancer, or an active and uncontrolled connective tissue disease
• People who have used immune-suppressing medications (including steroid tablets above a certain dose), chemotherapy, or steroid creams on the wound for more than two weeks within the month before screening, or who may need such medications during the study
• People whose wound has dead tissue, pus, or tunnels that cannot be removed by wound cleaning
• People who had a procedure to improve blood flow to the affected leg less than 4 weeks before the baseline visit
• People with certain elevated liver function test results within 30 days before screening (confirm with trial site)
• People with uncontrolled swelling, lymphedema, or vein-related pressure problems in the leg with the wound
• People whose wound was treated with a living skin substitute within the last 4 weeks before screening
• People whose wound was treated with a placenta-derived graft product within the last 4 weeks before screening
• People who, in the opinion of the study investigator, have any condition that could put them at undue risk or affect the quality of study data
• People who have been taking part in another clinical drug or device trial within 30 days before screening
• People whose wound is considered to be caused by something other than diabetes
• People who have a previous diagnosis of HIV or Hepatitis C, regardless of their current health status

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