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 foot ulcer measures between 0.7 cm² and 20.0 cm² after being cleaned and prepared by a medical professional
• People whose foot ulcer has been present for at least 4 weeks but no longer than 52 weeks before the first screening visit
• People whose ulcer is located on the foot, with at least half of the ulcer below the ankle bone
• People whose ulcer goes at least through the skin layers into the tissue beneath, and may reach the muscle, but does not expose any tendon or bone (confirm with trial site for grading details)
• People whose affected leg has been confirmed to have adequate blood flow through a vascular test done within the past 3 months (confirm with trial site for which test results qualify)
• People who have more than one foot ulcer, provided the ulcers are at least 2 cm apart — the largest qualifying ulcer will be selected for the study
• People who agree to use the prescribed pressure-relieving footwear or device throughout the study
• People who are able and willing to attend weekly study visits
• People who are willing and able to take part in the informed consent process

Who may not be able to join:

• People whose life expectancy is less than 6 months
• People whose foot ulcer is caused by something other than diabetes
• People whose target ulcer is currently infected, or who have a skin infection (cellulitis) in the skin around the ulcer
• People who have a bone infection linked to the target ulcer
• People who have an infection — either in the target ulcer or elsewhere in the body — that requires antibiotic treatment taken by mouth or through a drip
• People who are currently taking immune-suppressing medications, including steroid medications at doses higher than 10 mg of prednisone per day (or an equivalent dose), or chemotherapy
• People who have applied steroid cream or ointment directly to the ulcer within one month before the first screening visit
• People who have had a partial amputation on the affected foot, if that amputation has changed the shape of the foot in a way that makes proper pressure relief difficult
• People whose blood sugar control reading (HbA1c) was 12% or higher within the 3 months before the first screening visit
• People whose ulcer shrank by more than 20% in the 2 weeks before the first screening visit
• People whose ulcer shrinks by 20% or more during the 2-week screening period before being assigned to a treatment group
• People with an active or inactive Charcot foot condition that makes proper pressure relief of the ulcer difficult
• 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, in the opinion of the study doctor, have a medical or psychological condition that may affect how well study assessments can be completed
• People who have received hyperbaric oxygen therapy or a tissue/skin substitute product within the 30 days before the first screening visit
• People whose nutritional assessment score is below 17 on the Mini Nutritional Assessment tool, indicating a risk of malnutrition

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