Phase 4 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the 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 diabetic foot ulcers (DFU):

• People who are 21 years of age or older.
• People who have been diagnosed with type 1 or type 2 diabetes.
• People whose target wound measures between 1.0 cm² and 20.0 cm² after being cleaned and prepared by a medical professional.
• People whose target wound has been present for at least 4 weeks but no longer than 52 weeks before the first screening visit.
• People whose target wound is located on the foot, with at least half of the wound below the ankle bone.
• People whose target wound is a Wagner Grade 1 or 2 ulcer (meaning it extends at least into the deeper layers of skin or tissue, and may involve muscle, but is below the inner ankle bone) (confirm with trial site).
• People whose affected leg has adequate blood flow, confirmed by one of several accepted tests performed within 3 months of the first screening visit (confirm with trial site for which test applies).
• People who have two or more wounds that are separated by at least 2 cm after cleaning; the largest wound meeting all criteria will be selected as the target wound.
• People whose target wound on the bottom of the foot has been kept offloaded (pressure relieved) for at least 14 days before joining the trial.
• People who are willing to use the prescribed pressure-relieving method for the full duration of the study.
• People who are able and willing to attend weekly study visits as required.
• People who are able and willing to take part in the informed consent process.

For people with venous leg ulcers (VLU):

• People who are 21 years of age or older.
• People whose target wound measures between 1.0 cm² and 20.0 cm² after being cleaned and prepared by a medical professional.
• People whose target wound has been present for at least 4 weeks but no longer than 52 weeks before the first screening visit.
• People whose target wound has shown less than 40% reduction in size over the last 4 weeks, with no visible signs of healing.
• People whose affected leg has adequate blood flow, confirmed by one of several accepted tests performed within 3 months of the first screening visit (confirm with trial site for which test applies).
• People who have two or more wounds that are separated by at least 2 cm after cleaning; the largest wound meeting all criteria will be selected as the target wound.
• People who are able and willing to attend weekly study visits as required.
• People who are able and willing to take part in the informed consent process.

Who may not be able to join:

For people with diabetic foot ulcers (DFU):

• People whose life expectancy is known to be less than 6 months.
• People whose target wound is not caused by diabetes.
• People whose target wound is infected, requires antibiotic treatment taken by mouth or injection, or has a skin infection (cellulitis) in the surrounding area.
• People whose target wound exposes tendon or bone.
• People whose target wound is complicated by a bone infection (osteomyelitis).
• People who are taking immune-suppressing medications (including steroid tablets at doses above 10 mg of prednisone per day or equivalent), chemotherapy, or other medications the lead doctor believes could interfere with wound healing (such as biologics).
• People who have applied steroid cream or ointment directly to the wound within one month before the first screening visit.
• People who have had a partial amputation on the affected foot that causes a deformity making it difficult to properly relieve pressure on the target wound.
• People whose blood sugar control measurement (HbA1c) was 12% or higher within the 3 months before the first screening visit.
• People whose target wound shrank by more than 20% in the 2 weeks before the first screening visit.
• People whose target wound shrinks by 20% or more during the 2-week active screening period between the first screening visit and the first treatment visit.
• People who have an active or inactive Charcot foot condition that makes it difficult to properly relieve pressure on the target wound.
• People who are pregnant or planning to become pregnant within the next 6 months.
• People who have end-stage kidney disease and require dialysis.
• People who have taken part in a clinical trial using an experimental treatment within the past 30 days.
• People who, in the opinion of the lead investigator, have a medical or psychological condition that could interfere with study assessments.
• People who have received hyperbaric oxygen therapy or a specialised wound-healing product (called a CAMP) in the 30 days before the first screening visit.
• People who score below 17 on a standard nutritional assessment, indicating a risk of malnutrition.
• People whose wound has an active or hidden infection.
• People who have a condition that would create an unacceptable risk of complications following a procedure (confirm with trial site).

For people with venous leg ulcers (VLU):

• People whose life expectancy is known to be less than 6 months.
• People whose target wound is infected, requires antibiotic treatment taken by mouth or injection, or has a skin infection (cellulitis) in the surrounding area.
• People whose target wound exposes tendon or bone.
• People whose target wound is complicated by a bone infection (osteomyelitis).
• People who are taking immune-suppressing medications (including steroid tablets at doses above 10 mg of prednisone per day or equivalent), chemotherapy, or other medications the lead doctor believes could interfere with wound healing (such as biologics).
• People who have applied steroid cream or ointment directly to the wound within one month before the first screening visit.
• People whose blood sugar control measurement (HbA1c) was 12% or higher within the 3 months before the first screening visit.
• People whose target wound shrank by more than 20% in the 2 weeks before the first screening visit.
• People whose target wound shrinks by 20% or more during the 2-week active screening period between the first screening visit and the first treatment visit.
• People who are pregnant or planning to become pregnant within the next 6 months.
• People who have end-stage kidney disease and require dialysis.
• People who have taken part in a clinical trial using an experimental treatment within the past 30 days.
• People who, in the opinion of the lead investigator, have a medical or psychological condition that could interfere with study assessments.
• People who have received hyperbaric oxygen therapy or a specialised wound-healing product (called a CAMP) in the 30 days before the first screening visit.
• People who score below 17 on a standard nutritional assessment, indicating a risk of malnutrition.
• People whose wound has an active or hidden infection.
• People who have a condition that would create an unacceptable risk of complications following a procedure (confirm with trial site).

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