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:

For people with a diabetic foot ulcer (DFU):

• People who are 18 years of age or older
• People who have been diagnosed with type 1 or type 2 diabetes
• People whose foot wound measures between 1.0 cm² and 20 cm² after it has been cleaned up by a medical professional
• People whose foot wound has been present and receiving standard wound care for at least 4 weeks before the first screening visit
• People whose wound is located on the foot, with at least half of it below the ankle bone
• People whose wound is classified as Wagner grade 1 or 2 — meaning it goes at least into the deeper skin layers or fat tissue, but does not expose any tendon or bone (confirm with trial site)
• People whose leg has been confirmed to have adequate blood flow through one of several accepted vascular tests done within the past 3 months (confirm with trial site for which tests are accepted)
• People who have two or more wounds that are at least 2 cm apart (the largest qualifying wound will be the one studied)
• People who agree to use the prescribed pressure-relief method (such as a special boot or cast) for the whole study
• People who are able and willing to attend weekly study visits
• People who are willing and able to go through the informed consent process

For people with a venous leg ulcer (VLU):

• People who are 21 years of age or older
• People whose leg wound measures between 1.0 cm² and 20 cm² after it has been cleaned up by a medical professional
• People whose leg wound has been present and receiving standard wound care for at least 4 weeks before the first screening visit
• People whose leg has been confirmed to have adequate blood flow through one of several accepted vascular tests done within the past 3 months (confirm with trial site for which tests are accepted)
• People who have two or more wounds that are at least 2 cm apart after cleaning (the largest qualifying wound will be the one studied)
• People who are able and willing to attend weekly study visits
• People who are willing and able to go through the informed consent process

Who may not be able to join:

For people with a diabetic foot ulcer (DFU):

• People whose life expectancy is known to be less than 6 months
• People whose foot wound was not caused by diabetes
• People whose wound is currently infected, or where the surrounding skin shows signs of spreading infection (cellulitis)
• People whose wound exposes tendon or bone
• 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 taking immune-suppressing medications, including steroid tablets at doses above a certain level, chemotherapy drugs, or other medications the trial doctor believes may slow wound healing (such as certain biologic drugs)
• People who are taking a medication called hydroxyurea
• People who have applied steroid creams directly to the wound within the past month
• People who have had a partial foot amputation that has changed the shape of the foot in a way that makes proper pressure relief difficult
• People whose blood sugar control marker (HbA1c) was 12% or higher within the past 3 months
• People whose wound has shrunk by more than 40% in the 4 weeks before the first treatment visit, or has shrunk significantly during the screening period (confirm with trial site for exact measurements)
• People who have an active Charcot foot condition, or an inactive one that makes proper pressure relief difficult (a serious foot and joint complication)
• Women who are pregnant or planning to become pregnant within the next 6 months
• People who have severe kidney disease requiring dialysis
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days
• People who, in the trial doctor's opinion, have a medical or mental health condition that could affect the study assessments
• People who have received hyperbaric oxygen therapy or a special wound-covering product (called a CAMP) within the past 30 days
• People who score below 17 on a standard nutrition assessment tool, indicating risk of malnutrition

For people with a venous leg ulcer (VLU):

• People whose life expectancy is known to be less than 6 months
• People whose wound is infected, requires antibiotic tablets or injections, or where the surrounding skin shows signs of spreading infection (cellulitis)
• People whose wound exposes tendon or bone
• People whose wound shows signs of bone infection (osteomyelitis)
• People who are taking immune-suppressing medications, including steroid tablets at doses above a certain level, chemotherapy drugs, or other medications the trial doctor believes may slow wound healing (such as certain biologic drugs)
• People who have applied steroid creams directly to the wound within the past month
• People whose blood sugar control marker (HbA1c) was 12% or higher within the past 3 months
• People whose wound has shrunk by more than 40% in the 4 weeks before the first treatment visit, or has shrunk significantly during the screening period (confirm with trial site for exact measurements)
• Women who are pregnant or planning to become pregnant within the next 6 months
• People who have severe kidney disease requiring dialysis
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days
• People who, in the trial doctor's opinion, have a medical or mental health condition that could affect the study assessments
• People who have received hyperbaric oxygen therapy or a special wound-covering product (called a CAMP) within the past 30 days
• People who score below 17 on a standard nutrition assessment tool, indicating risk of malnutrition
• People whose wound has an active or hidden infection
• People who have a condition that the trial doctor believes would create an unacceptable risk of complications (confirm with trial site)

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