Follow-up Study Evaluating Safety of ALLO-ASC-DFU Treatment for Diabetic Foot Ulcer After Phase 3 Trial

What this Trial Is About

This research aims to evaluate the long-term safety of ALLO-ASC-DFU treatment in people who previously participated in a phase 3 clinical trial for Diabetic Foot Ulcer. ALLO-ASC-DFU is a hydrogel sheet containing stem cells from donated fat tissue that may help reduce inflammation and support wound healing. The study focuses on safety outcomes over a 24-month follow-up period. Participants in this open-label follow-up were previously treated with either the ALLO-ASC-DFU sheet or a Vehicle sheet during the earlier phase 3 trial. There is no new treatment given in this follow-up. The study observes the participants who received these treatments to monitor for any safety concerns over two years. During the study, researchers will monitor participants for abnormal lab test results up to 9 months, changes in physical exams and vital signs up to 18 months, and any local reactions at the treatment area up to 24 months. They will also track any adverse events throughout the 24 months. Participants will be involved in regular assessments to evaluate these safety outcomes under medical supervision.

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial