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:

• People who are 18 years of age or older.
• People who have been diagnosed with type 1 or type 2 diabetes.
• People whose wound (after being cleaned) measures between 1.0 cm² and 25.0 cm², as measured using a specific imaging device called MolecuLight®.
• People whose wound has been present and treated with standard care for at least 4 weeks but no longer than 52 weeks before the first screening visit.
• People whose wound is located on the foot, with at least half of the wound below the ankle bone.
• People whose wound goes all the way through the skin layers but does not have bone visibly exposed.
• People whose blood flow to the affected leg has been confirmed as adequate through one of several accepted tests within the past 3 months (confirm with trial site for which test applies).
• People who have more than one wound, provided the wounds are at least 2 cm apart — the largest wound that meets all the criteria would be selected for the study.
• People whose wound is on the bottom of the foot and has been kept off-loaded (pressure relieved) for at least 14 days before joining the study.
• People who agree to use the prescribed pressure-relief method for the full duration of the study.
• People who agree to attend weekly study visits as required.
• People who are willing and able to take part in the informed consent process.

Who may not be able to join:

• People with a life expectancy of less than 6 months.
• People whose wound is not caused by diabetes.
• People whose wound is currently infected, or where the surrounding skin shows signs of spreading infection (cellulitis).
• People whose wound has exposed tendon or bone visible.
• People whose wound shows signs of bone infection (osteomyelitis).
• People who have an infection in the wound or elsewhere in the body that requires antibiotic tablets or injections.
• People who are currently taking immune-suppressing medications, including steroid tablets at doses above a certain level, chemotherapy, or other medications that the study doctor believes may slow wound healing (such as certain biologic medicines).
• People who are currently taking a medication called hydroxyurea.
• People who have applied steroid creams or ointments directly to the wound within one month before the first screening visit.
• People who have had a partial amputation on the affected foot that has changed the shape of the foot in a way that makes proper pressure relief of the wound difficult.
• People whose blood sugar control measure (HbA1c) was 12% or higher within the 3 months before the first screening visit.
• People whose wound has already shrunk by more than 20% in the 2 weeks before the first screening visit.
• People whose wound shrinks by 20% or more during the 2-week screening period before formally joining the study.
• People with an active Charcot foot condition, or an inactive Charcot foot that makes it difficult to properly relieve pressure on the wound.
• People who are pregnant or planning to become pregnant within the next 6 months.
• People with end-stage kidney disease who require dialysis.
• People who have taken part in another clinical trial involving an investigational treatment within the past 30 days.
• People who, in the study doctor's opinion, have a medical or psychological condition that may affect how well the study assessments can be carried out.
• People whose wound was treated with hyperbaric oxygen therapy or certain advanced wound care products (such as skin substitute products) within the 30 days before the first screening visit.
• People identified as malnourished based on a standard nutrition screening tool called the Mini Nutrition Assessment (a score below 17).

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