NCT05438251

Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Research Study to evaluate the therapeutic effect of Fespixon cream in patients suffering from DFU (UTWCS Grade III-A or III-B) by measuring the change of grade of UTWCS (University of Texas Diabetic Wound Classification system), wound area reduction, infection control, and incidence of treatment-emergent adverse event (TEAE).

Detailed description

This study is designed as a single-arm, open-label, one-center study to evaluate the therapeutic effect of Fespixon cream in patients suffering from DFU (UTWCS Grade III-A or III-B). The duration of this study is: run-in/ screening phase (7 days ± 3 days); treatment phase (12 weeks); follow-up phase (2 weeks ± 4 days), and visits are conducted every week during the run-in/ screening phase and every 2 weeks during the treatment phase and follow-up phase for a total of 9 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer twice a day for a maximum period of 12 weeks, until the target ulcer downgrade from UTWCS grade III-A or III-B to I-A, I-B, II-A, or II-B 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 grade-down at the end of the treatment phase will be followed for 2 weeks. During the follow-up phase, standard of care or other treatment modalities (with an exception of investigational treatment/ medications) will be used for all subjects at the discretion of the investigator. At each visit, the size and changes of the target ulcer are recorded by photographing. The target ulcer area in the photo is calculated using Image-Pro® Plus software.

Conditions

• Diabetic Foot Ulcer (DFU)

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 (approximately 2 mm in thickness) 5. Dosing schedule: Apply twice a day 6. Duration: up to 12 weeks

Timeline

• Start date: 2022-08-04
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2022-06-29
• Last updated: 2024-05-16

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study