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

NCT05438251 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-05-16

No results posted yet for this study

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).

Conditions

  • Diabetic Foot Ulcer (DFU)

Interventions

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

Sponsors & Collaborators

  • China Medical University Hospital

    collaborator OTHER

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shyi-Gen Chen, VP · Oneness Biotech Co., Ltd.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2024-04-03
Completion
2024-04-03
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438251 on ClinicalTrials.gov