Peripheral Arterial Disease 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 20.0 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
• The ulcer must be on your foot, with at least half of it located below the ankle bone
• The ulcer must be a certain depth — going through the skin layers or into the tissue beneath, but must not expose any tendon or bone (confirm with trial site)
• The blood flow in the affected leg must be good enough, confirmed by a vascular (blood flow) test done within the past 3 months
• If you have more than one ulcer, they must be at least 2 cm apart, and the largest qualifying ulcer will be the one studied
• If your ulcer is on the bottom of your foot, you must have been using a pressure-relieving method (such as a special boot or cast) for at least 14 days before joining
• You must agree to use the prescribed pressure-relieving footwear or device for the entire duration of the study
• You must be willing and able to attend weekly study visits
• You must be willing and able to go through the consent process to join the study

Who may not be able to join:

• People with a life expectancy of less than 6 months
• People whose foot ulcer is not caused by diabetes
• People whose target ulcer is currently infected, or who have a skin infection (redness/swelling) around the ulcer
• People who have a bone infection related to the ulcer
• People who have any infection — in or near the ulcer or elsewhere — that requires antibiotic tablets, injections, or infusions
• People currently taking immune-suppressing medications or chemotherapy drugs (including steroid tablets above a certain dose — confirm details with trial site)
• People who have applied steroid creams or ointments directly to the ulcer within the past month
• People who have had a partial amputation on the affected foot that makes it difficult to properly relieve pressure on the ulcer
• 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 they are enrolled
• People whose blood sugar control marker (HbA1c) is 12% or higher within the past 3 months
• People with an active or inactive Charcot foot condition (a serious foot bone/joint problem) that makes proper pressure relief difficult
• Women who are pregnant or planning to become pregnant within the next 6 months
• People with end-stage kidney disease who require dialysis
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days
• People who have a medical or psychological condition that, in the doctor's opinion, might interfere with the study
• People who have received hyperbaric oxygen therapy (a pressurised oxygen treatment) or certain advanced wound care products within the past 30 days
• People who are malnourished, based on a standard nutrition assessment score (confirm with trial site)

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