NCT05338463

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Cathay General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Fespixon Cream	1. Name : Fespixon Cream 2. Dosage form: Topical cream, 15 g ointment per tube 3. Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) 4. Dose(s): Apply 1 cc per 5 cm\^2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply twice a day 6. Duration: up to 20 weeks

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2022-04-21
• Last updated: 2024-04-03

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study