Phase 4 Peripheral Neuropathy 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:

• People who are 18 years of age or older
• People who have been diagnosed with type 1 or type 2 diabetes
• People who have more than one ulcer, where the ulcer being treated in this trial is the same one that was treated in the previous BIOCAMP study
• People who are willing to use the prescribed pressure-relieving method (such as a special boot or cast) for the full length of the study
• People who are able to attend weekly visits at the study site as required
• People who are able to understand and agree to take part through the informed consent process
• People who took part in the BIOCAMP trial in the standard care only group and whose wound had not fully healed by the 12-week mark

Who may not be able to join:

• People whose life expectancy is estimated to be less than 6 months
• People whose wound is not caused by diabetes
• People whose wound is currently infected, or who have a skin infection (cellulitis) around the wound
• People whose wound is deep enough to expose a tendon or bone
• People who have a bone infection (osteomyelitis) affecting the wound area
• People who have an infection in the wound or elsewhere in the body that requires antibiotic treatment taken by mouth or through a drip
• People who are taking immune-suppressing medications, including steroid tablets at doses higher than 10 mg of prednisone per day (or an equivalent dose), cancer chemotherapy, or other medications that the trial doctor believes may slow wound healing (such as certain biological therapies)
• People who are taking a medication called hydroxyurea
• People who have applied steroid creams or ointments directly to the wound within one month before the first trial visit
• People who have had a partial amputation on the affected foot that has changed the shape of the foot in a way that makes proper pressure relief of the wound difficult
• People whose HbA1c (a blood test measuring average blood sugar levels over time) was 12% or higher within three months before the first trial visit
• People who have an active Charcot foot condition, or an inactive Charcot foot that makes proper pressure relief of the wound difficult (confirm with trial site)
• Women who are pregnant or planning to become pregnant within the next 6 months
• People who have severe kidney disease and require dialysis
• People who, in the trial doctor's opinion, have a medical or mental health condition that may affect how well the study assessments can be carried out
• People whose Mini Nutritional Assessment score is below 17, which may indicate malnutrition (confirm with trial site)
• People who did not take part in the previous BIOCAMP trial
• People who took part in the BIOCAMP trial but were not in the standard care only group
• People who took part in the BIOCAMP trial and whose wound fully healed during that study
• People whose wound was treated with skin substitutes, cellular or tissue-based products (CAMPs), or hyperbaric oxygen therapy within the month before the first trial visit

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