Type 2 Diabetes 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:

• You are 18 years of age or older.
• You have been diagnosed with type 1 or type 2 diabetes.
• Your foot ulcer measures between 0.7 cm² and 5.0 cm² after being cleaned and prepared by a medical professional.
• Your foot ulcer has been present for at least 4 weeks but no longer than 52 weeks before your first screening visit.
• Your ulcer is located on the foot, with at least half of it below the ankle bone.
• Your ulcer goes through the skin into deeper tissue but does not expose any tendon or bone (confirm with trial site for exact grading).
• A test done within the last 3 months shows that blood is flowing adequately to the affected leg and foot (confirm with trial site for which test applies to you).
• If you have more than one ulcer, they must be at least 2 cm apart, and the largest qualifying one will be the focus of the study.
• If your ulcer is on the bottom of your foot, it must have been properly offloaded (pressure relieved) for at least 14 days before joining.
• You are willing to use the prescribed pressure-relief method (such as a special boot or cast) for the entire study.
• You are able and willing to attend weekly study visits.
• You are able to understand and agree to the consent process.

Who may not be able to join:

• Your life expectancy is expected to be less than 6 months.
• Your foot ulcer is not caused by diabetes.
• Your ulcer is currently infected, or the surrounding skin shows signs of infection (redness, swelling spreading from the wound).
• Your ulcer exposes tendon or bone.
• There is evidence of a bone infection related to the ulcer.
• You have an infection in the ulcer or elsewhere in your body that requires antibiotic treatment taken by mouth or through an IV.
• You are taking medications that suppress your immune system, such as high-dose steroids, chemotherapy, or certain biologic drugs (confirm with trial site).
• You are currently taking a medication called hydroxyurea.
• You have applied steroid creams or ointments directly to the ulcer within the past month.
• You have had a partial amputation on the affected foot that makes it difficult to properly relieve pressure on the ulcer.
• Your recent blood sugar control test (HbA1c) showed a result of 12% or higher within the past 3 months.
• Your ulcer has already shrunk by more than 20% in the 2 weeks before your first screening visit.
• Your ulcer shrinks by 20% or more during the 2-week screening period before the study begins.
• You have an active or inactive Charcot foot condition that makes proper pressure relief difficult (confirm with trial site).
• You are pregnant or planning to become pregnant within the next 6 months.
• You have end-stage kidney disease and require dialysis.
• You have taken part in another clinical trial using an experimental treatment within the last 30 days.
• You have a medical or psychological condition that the study doctor believes could interfere with the study (confirm with trial site).
• You have received hyperbaric oxygen therapy or a special wound-healing skin product within the 30 days before your first screening visit.
• Your nutritional assessment score indicates significant malnutrition (confirm with trial site).
• Your wound has an active or hidden infection.
• You have a condition that would create an unacceptable risk of complications from any procedures involved in the study (confirm with trial site).
• You have a known allergy to a type of antibiotic called aminoglycosides.

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