Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients

NCT05338463 | Completed Phase 4 FDA Drug

• 1 other identifier: ON101CLAS06
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Diabetic Foot Ulcer

Keywords

Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A); Dialysis patients; Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related Adverse Events associated with Fespixon cream

  Assessment of Safety: Safety will be assessed based on the incidence of adverse events, including overall AEs, Fespixon-related AEs, target ulcer-related AEs, and SAEs. During the trial, in addition to self-reported AEs, physicians will check physical examination, vital signs, and laboratory reports to determine the presence of AEs

  Time Frame: 20 weeks

Secondary Outcomes (2)

• Incidence of complete healing of the target ulcer

  Time Frame: 20 weeks

• Time to complete ulcer healing

  Time Frame: 20 weeks

Study Arms (1)

Fespixon Cream

EXPERIMENTAL

A single arm of Fespixon Cream for DFU (TEXAS 1A, 2A) in dialysis patients Test 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 (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply twice a day 6. Duration: up to 20 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 (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply twice a day 6. Duration: up to 20 weeks

Also known as: ON101 Cream

Fespixon Cream

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%.
• Subjects maintain regular/stable blood purification treatment of hemodialysis (HD) or peritoneal dialysis (PD) for ≥6 months prior to Visit 0.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• A full-thickness ulcer of UTWCS Grade I-A or II-A
• Ulcer size (area) is \> 1 cm² and ≤ 10 cm² (post-debridement at time of enrollment)
• Ulcer is located on or below the malleoli.
• Ulcer presents for \> 4 weeks (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).
• No active infection by clinical inspection as defined by IDSA/IWGDF criteria. 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.
• Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥0.7 and \< 1.3, transcutaneous pressure of oxygen (TcPO2) ≥30 mmHg on at least one lead, or Doppler ultrasound related test to ensure no serious embolisms/no serious clogging of blood vessels. .
• Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \[female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectable, combination oral contraceptives, transdermal patches, or contraceptive rings\], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and/or who have been sterilized).
• Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
• Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.
• A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

You may not qualify if:

• In response to standard of care, ulcer size reduction is \> 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V1).
• Body mass index (BMI) \> 35 kg/m2
• Laboratory values at Screening of:
• Hemoglobin \< 6.0 g/dL
• White Blood Cells (WBC) \< 3.0 X 103 cells/uL； \> 12.0 X 103 cells/uL
• 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 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
• 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.
• Subject is currently receiving (i.e., within 30 days of enrollment visit) or scheduled to receive any of following medication or therapies, could interfere with wound healing during the course of the study.
• immunosuppressant (including chronic systemic corticosteroids)
• cytotoxic chemotherapy
• cytostatic therapy

Sponsors & Collaborators

• Cathay General Hospital: lead
• Oneness Biotech Co., Ltd.: collaborator

Study Sites (1)

Cathay General Hospital

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Chi-Ming Pu, MD

  Cathay General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of plastic surgery

Model Details: The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: December 1, 2021
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)