Phase 4 Type 1 Diabetes 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 who have more than one foot ulcer, where the ulcer being treated in this trial is the same one that was treated in the previous CAMPX study.
• People who are willing to use the prescribed pressure-relief method (such as a special boot or cast) for the full duration of the study.
• People who are able to attend weekly study visits as required.
• People who are able to understand and agree to the consent process for joining a study.
• People who took part in the CAMPX trial, were placed in the standard care only group, and whose ulcer had not fully healed by the 12-week mark.

Who may not be able to join:

• People who are expected to live fewer than 6 months.
• People whose foot ulcer is not caused by diabetes.
• People whose ulcer is currently infected, or where the surrounding skin shows signs of infection (confirm with trial site).
• People whose ulcer is deep enough to expose a tendon or bone.
• People who show signs of a bone infection connected to the ulcer.
• People who have an infection — either in the ulcer or elsewhere in the body — that requires antibiotic tablets or injections.
• People who are taking immune-suppressing medicines, high-dose steroid tablets (above a certain daily dose), chemotherapy, or other medicines that the trial doctor believes could slow wound healing.
• People who have applied steroid cream or ointment 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 blood sugar control measure (HbA1c) was 12% or higher within the past 3 months.
• People who have an active or inactive Charcot foot condition (a serious foot bone disorder) that makes it difficult to properly relieve pressure on the ulcer.
• Women who are pregnant or planning to become pregnant within the next 6 months.
• People who have end-stage kidney disease and require dialysis.
• People who, in the trial doctor's opinion, have a medical or psychological condition that may affect study results.
• People who score below 17 on a standard nutrition assessment tool, indicating significant malnutrition.
• People who did not take part in the CAMPX trial.
• People who took part in the CAMPX trial but were not placed in the standard care only group.
• People who took part in the CAMPX trial and whose ulcer fully healed during that study.

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