Chronic Diabetic Foot Ulcer Clinical Trial
Official title:
Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in dialysis patients This study aimed to evaluate the effects of a topical cream containing Plectranthus amboinicus and Centella Asiatica when applied topically to diabetic foot ulcers in uremia patients with PAOD.
This study is designed as a single-arm, open-label study to evaluate the efficacy and safety of Fespixon Cream for the treatment of chronic diabetic foot ulcers (DFUs) in dialysis. Twelve(12) eligible subjects with DFUs and undergoing dialysis will be enrolled and assigned to receive Fespixon treatment for 20 weeks. During the treatment phase, the Fespixon cream will be applied to the target ulcer twice a day for a maximum period of 20 weeks, until the ulcer closure (ulcer size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 2 weeks. Identical standard of care (SoC) procedure will be performed throughout the study period, which including ulcer cleansing and debridement (if necessary) until complete ulcer closure. At each visit, the size and changes of the target ulcer are recorded by photographing, and calculated using Image® software. The study consists of three periods, a 2-week Screening/Run-in period, an up-to-20-week Treatment period, and a 2-week Follow-up period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05849701 -
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
|
N/A | |
| Terminated |
NCT04838600 -
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
|
||
| Completed |
NCT00709514 -
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
|
Phase 2 |