Phase 4 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 HbA1c blood sugar level is below 12% (a measure of average blood sugar over time)
• People whose target foot ulcer measures between 0.7 cm² and 20.0 cm² in size after wound cleaning
• People whose target foot ulcer has been present for at least 4 weeks before the screening visit
• People whose target foot ulcer is located on the foot, with at least half of the wound below the ankle bone
• People whose target foot ulcer is a moderate-depth wound (classified as Wagner grade 1 or 2), meaning it goes through the skin layers and possibly into muscle, but does not expose tendon or bone
• People whose affected leg has been confirmed to have adequate blood flow, assessed within the past 3 months using one of several accepted medical tests (confirm with trial site for details)
• People with more than one foot ulcer, provided the ulcers are at least 2 cm apart (the largest qualifying ulcer would be the focus of the trial)
• People who are willing to use the pressure-relief method prescribed for the foot throughout the study
• People who agree to attend all required study visits
• People who are willing and able to take part in the informed consent process

Who may not be able to join:

• People with a known life expectancy of less than 6 months
• People whose target ulcer is not caused by diabetes
• People whose target ulcer is infected, or who have a skin infection (cellulitis) around the ulcer
• People with a bone infection (osteomyelitis) connected to the target ulcer
• People who have an infection in or around the target ulcer that requires antibiotic treatment taken by mouth or injection
• 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 who are receiving chemotherapy
• People who have applied steroid creams or ointments directly to the ulcer within one month before the screening visit
• People who have had a partial amputation on the affected foot that makes it difficult to properly relieve pressure from the target ulcer
• People whose target ulcer has already shrunk by more than 20% in the two weeks before the screening visit
• People who score below 17 on a standard nutrition assessment tool (the Mini Nutritional Assessment)
• People with an active Charcot foot (a serious bone and joint condition in the foot), or an inactive Charcot foot that makes proper pressure relief difficult
• Women who are able to become pregnant and are currently pregnant, planning to become pregnant within the next 4 months, or unwilling to use an appropriate form of contraception
• People who are currently on dialysis or planning to start dialysis
• People with a medical or psychological condition that, in the opinion of the trial investigator, may interfere with the study
• People who have received hyperbaric oxygen therapy or a specific type of wound treatment made from human placental tissue in the 30 days before the screening visit
• People with a known allergy or sensitivity to the antibiotics ofloxacin, vancomycin, or amphotericin
• People who have taken part in another clinical trial involving an investigational treatment within the past 30 days

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