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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
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
China Medical University Hospital
Taichung, Taiwan
Incidence of the grade down of the target ulcer
Ulcer grade down is defined as ulcer downgrading from 3A or 3B to 1A, 1B, 2A, or 2B confirmed at two consecutive study visits 2 weeks apart.
Time frame: 12 weeks
Time to the ulcer grade down
* Ulcer grade down is defined as ulcer downgrading from 3A or 3B to 1A, 1B, 2A, or 2B confirmed at two consecutive study visits 2 weeks apart. * Time to the ulcer grade down was defined as "time to the first visit of ulcer grade down of the target ulcer."
Time frame: 12 weeks
Mean change from baseline in the target ulcer area confirmed by Image-Pro® Plus calculation of the wound area
The target ulcer area at each visit is confirmed by Image-Pro® Plus software and presented as a mean change from the baseline.
Time frame: 12 weeks
Percentage change from baseline in the target ulcer area confirmed by Image-Pro® Plus calculation of the wound area
The target ulcer area at each visit is confirmed by Image-Pro® Plus software and presented as a percentage change from the baseline.
Time frame: 12 weeks
Percentage of ulcer improvement
Ulcer improvement is defined as ulcer downgrading from 3A or 3B to 1A, 1B, 2A, or 2B confirmed at two consecutive study visits 2 weeks apart.
Time frame: 12 weeks
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