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

NCT05438251 | Terminated Phase 4 FDA Drug

• 1 other identifier: ON101CLAS08
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

ON101; Fespixon; Diabetic Foot Ulcer; TEXAS 3A/3B

Outcome Measures

Primary Outcomes (2)

• 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.

  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."

  12 weeks

Secondary Outcomes (3)

• Mean change from baseline in the target ulcer area confirmed by Image-Pro® Plus calculation of the wound area

  12 weeks

• Percentage change from baseline in the target ulcer area confirmed by Image-Pro® Plus calculation of the wound area

  12 weeks

• Percentage of ulcer improvement

  12 weeks

Study Arms (1)

Diabetic Foot Ulcers (TEXAS 3A, 3B)

EXPERIMENTAL

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

Drug: Fespixon Cream

Interventions

Fespixon Cream DRUG

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

Also known as: ON101 cream

Diabetic Foot Ulcers (TEXAS 3A, 3B)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.
• Subject has a glycosylated hemoglobin, HbA1c ≤ 12%.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• A full-thickness ulcer of UTWCS Grade III-A or III-B
• Ulcer size (area) is \>2 cm\^2 and ≤30 cm\^2 (post-debridement at time of enrollment)
• Ulcer is located on or below the malleoli.
• Ulcer presents for \>1 week (at time of enrollment).
• There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, (post-debridement).
• The infection severity of the target ulcer is defined as uninfected, mild, or moderate infection by IDSA/ IWGDF Guidelines. (IDSA/IWGDF-defined severe infection would be excluded)
• Note:
• If the subject has more than one qualifying diabetic foot ulcer, the most severe ulcer will be designated as the target ulcer; meanwhile, the depth of the wound will the consideration prior to the area of the wound.
• Any foot infection with the following signs of a systemic inflammatory response syndrome is defined as severe infection according to IDSA Infection Severity. This response is manifested by two or more of the following conditions:
• temperature\>38℃ or \<36℃
• heart rate \> 90 beats/minute
• respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg

You may not qualify if:

• Other laboratory values at Screening of:
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST), and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 2.5 g/dL
• Presence of any clinically significant medical condition(s) in medical history during the screening period that, in the opinion of the investigator, could interfere with wound healing, including but not limited to the following:
• Acute or unstable Charcot foot
• Current sepsis
• Active malignant disease. A subject, who has had a malignant disease in the past, was treated, and is currently disease-free, may be considered for study entry
• Acquired immune deficiency syndrome (AIDS) or HIV positive
• Has a known hypersensitivity to any of the investigational drug or the related components
• X-ray or MRI scan is as a mandatory screening to rule out osteomyelitis
• Subject is currently receiving (i.e., within 30 days of enrollment visit) or scheduled to receive any of the following medication or therapies, which could interfere with wound healing during the course of the study.
• immunosuppressant (including chronic systemic corticosteroids)
• cytotoxic chemotherapy
• cytostatic therapy
• autoimmune disease therapy

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead
• China Medical University Hospital: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Shyi-Gen Chen, VP

  Oneness Biotech Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Uncontrolled; Open-label; Randomized: N/A; Single Arm; Duration of treatment: up to 12 weeks; Titration: no; One-center(Taiwan)

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: August 4, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)