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:

• People aged 50 to 85 years old who are able to walk and move around
• People who are willing and able to give their consent to participate and follow the study requirements
• People who have a diabetic foot ulcer (an open wound on the foot caused by diabetes) that goes at least through the outer layers of skin, located on the foot below the ankle bone
• If a person has more than one qualifying foot ulcer, the largest one will be chosen as the main wound being studied
• The main wound must be able to be photographed and measured using a specific digital measurement tool called eKare Insights
• Any other wounds not being studied must be more than 2 cm away from the main wound
• The main wound must have first appeared at least 4 weeks before the screening visit, but less than 52 weeks before signing the consent form
• The main wound must measure larger than 1.0 cm² and smaller than 25 cm² at the screening visit and at the first wound care visit
• The main wound must have been properly offloaded (pressure relieved, such as with a special boot or device) throughout the entire lead-in period before being assigned to a treatment group
• People who are under the care of a doctor for their diabetes and other health conditions
• The foot with the main wound must have adequate blood flow, confirmed by one of the following tests within 30 days of screening: a specific blood pressure ratio test (ABI and TBI), an oxygen level test through the skin (TcPO2), or an ultrasound showing normal blood flow in two specific foot arteries (confirm with trial site for details)

Who may not be able to join:

• People whose main foot wound was caused by something other than diabetes
• People who have five or more diabetic foot ulcers or leg ulcers on the same limb being studied
• People whose foot ulcer is related to a condition called Charcot foot (a type of bone and joint damage)
• People who have used an antibiotic-containing wound dressing on the wound within the 4 weeks before screening
• People whose main wound is suspected or confirmed to be cancerous
• People whose wound area has received radiation treatment
• People with leg ulcers caused by vein problems (even if they also have diabetes)
• People with an active infection at or near the main wound
• People whose main wound shrank by 20% or more during the 4-week lead-in period
• People with an active bone infection in the affected foot, confirmed by X-ray or MRI within 30 days of the first wound care visit
• People with Raynaud's disease (a condition affecting blood flow to the extremities)
• People with severely blocked arteries in the affected limb that are not able to be treated and may prevent the wound from healing
• People who have taken immune-suppressing medications, including steroid tablets or injections, for 2 weeks or more within the 30 days before screening, or who are expected to need them during the study
• People who have had an active cancer being treated within 30 days before the first wound care visit, or who are expected to need cancer treatment during the study
• People who have received chemotherapy within 30 days of the first wound care visit, or who are expected to need it during the study
• People with poorly controlled diabetes, defined as a blood sugar control test (HbA1c) result of 12.0% or higher within 30 days of the first wound care visit
• People who are currently participating in, or have participated in, another clinical trial of a device, biologic, or drug within 30 days of the first wound care visit
• People who have had an advanced skin substitute product used on the main wound within 60 days of the first wound care visit
• People whose main wound has been treated with, or is expected to be treated with, any of the following during the study: growth factor products, steroid creams on the wound, immune-modifying medications that could affect treatment, or specific wound care products including Scarlet Red dressing, Dakin's solution, Mafenide acetate, Tincoban, zinc sulfate, povidone-iodine solution, Polymyxin/nystatin, or Chlorhexidine
• People who are taking a COX-2 inhibitor medication, such as celecoxib (Celebrex), valdecoxib (Bextra), or amlodipine (Consensi)
• People with a high level of a waste product in the blood (serum creatinine above 2.5 mg/dL) within 30 days of the first wound care visit, which may indicate reduced kidney function
• People with an autoimmune connective tissue disease (a condition where the immune system attacks the body's own tissues)
• People with end-stage kidney disease
• People with any condition that would seriously affect their ability to complete the study
• People with a known history of not following through with medical treatment or appointments
• People who are pregnant or planning to become pregnant during the study
• People with a life expectancy of less than one year

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