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:

• You must be 18 years of age or older.
• You must have been diagnosed with type 1 or type 2 diabetes.
• You must have a foot ulcer that measures between 1.0 cm² and 5.0 cm² in size after any wound cleaning has been done.
• Your foot ulcer must have been present for at least 4 weeks but no longer than 52 weeks before your first screening visit.
• Your ulcer must be on the foot, with at least half of it located below the ankle bone.
• Your ulcer must be of a certain depth (reaching at least through the skin layers into the fat beneath, and possibly into muscle), but must not expose any tendon or bone (confirm with trial site).
• The blood flow to your affected leg and foot must be adequate, confirmed by one of several standard tests done within 3 months before screening (confirm with trial site).
• If you have more than one foot ulcer, they must be at least 2 cm apart from each other.
• You must be willing to use the prescribed pressure-relieving footwear or device for the entire study.
• You must be able to attend weekly study visits as required.
• You must be willing and able to give your informed consent to take part.

Who may not be able to join:

• People who are not expected to live longer than 6 months are not eligible.
• People whose foot ulcer is caused by something other than diabetes are not eligible.
• People whose target ulcer is currently infected, or who have a skin infection (redness and swelling) around the ulcer, are not eligible.
• People who have a bone infection related to the target ulcer are not eligible.
• People who currently need antibiotic tablets or injections for any infection — either in the ulcer or elsewhere in the body — are not eligible.
• People who are taking immune-suppressing medications or chemotherapy drugs are not eligible (this includes steroid medications above a certain dose).
• People who have had steroid cream or ointment applied directly to the ulcer within the past month are not eligible.
• People who have had a partial amputation on the affected foot that makes it difficult to properly relieve pressure from the ulcer are not eligible.
• People whose ulcer has already shrunk by more than 20% in the 2 weeks before the first screening visit are not eligible.
• People whose ulcer shrinks by 20% or more during the 2-week screening period before the study officially begins are not eligible.
• People who are considered malnourished based on a standard nutrition assessment score are not eligible.
• People who have an active or inactive Charcot foot condition (a serious foot deformity related to nerve damage) that makes it hard to properly relieve pressure from the ulcer are not eligible.
• Women who are pregnant or planning to become pregnant within the next 6 months are not eligible.
• People with severe kidney disease who require dialysis are not eligible.
• People who, in the opinion of the study doctor, have a medical or mental health condition that could affect study results are not eligible.
• People who have received hyperbaric oxygen therapy (a specialised oxygen treatment) or certain advanced wound care products within the 30 days before screening are not eligible.

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