search
Back to results

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

Primary Purpose

Chronic Diabetic Foot Ulcer

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Fespixon Cream
Sponsored by
Cathay General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Diabetic Foot Ulcer focused on measuring Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A), Dialysis patients, Peripheral Arterial Occlusive Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.
  3. Subjects maintain regular/stable blood purification treatment of hemodialysis (HD) or peritoneal dialysis (PD) for ≥6 months prior to Visit 0 (V0).
  4. Presence of at least one diabetic foot ulcer that meets all of the following criteria:

    1. A full-thickness ulcer of UTWCS Grade I-A or II-A
    2. Ulcer size (area) is > 2 cm2 and ≤ 10 cm2 (post-debridement at time of enrollment)
    3. Ulcer is located on or below the malleoli.
    4. Ulcer presents for > 4 weeks (at time of enrollment).
    5. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, (post-debridement).
    6. 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.
  5. 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. .
  6. 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).
  7. Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
  8. Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.
  9. A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

Exclusion Criteria:

  1. 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).
  2. Body mass index (BMI) > 35 kg/m2
  3. Laboratory values at Screening of:

    1. Hemoglobin < 6.0 g/dL
    2. White Blood Cells (WBC) < 3.0 X 103 cells/uL; > 12.0 X 103 cells/uL
    3. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
    4. Albumin < 2.5 g/dL
  4. 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:

    1. Acute or unstable Charcot foot
    2. 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.
    3. Acquired immune deficiency syndrome (AIDS) or HIV positive.
  5. 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.

    1. immunosuppressant (including chronic systemic corticosteroids)
    2. cytotoxic chemotherapy
    3. cytostatic therapy
    4. autoimmune disease therapy
    5. growth factors
    6. hyperbaric oxygen therapy
    7. bioengineered tissue or skin substitutes(ADM)
    8. application of topical steroids to the ulcer
    9. use of any investigational drug(s)
  6. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse, determined from the subject's medical history, which, in the opinion of the investigator, may pose a threat to subject compliance.
  7. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.

Note ( Based on TEXAS 1A, 2A, the below information is to further calcification, and potential subjects meeting any of the following items will be excluded from the study.) :

  1. Ulcers with exposed bone or associated with osteomyelitis. (The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings as deemed necessary by the Investigator.)
  2. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
  3. Current sepsis
  4. Subjects who need to stand continuously for more than 4 hours / day and have difficulty complying with off-loading instructions.

Sites / Locations

  • Cathay General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fespixon Cream

Arm Description

A single arm of Fespixon Cream for DFU (TEXAS 1A, 2A) in dialysis patients Test drug : Name : Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply twice a day Duration: up to 20 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of complete healing of the target ulcer
Incidence of complete healing of the target ulcer : measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Time to complete ulcer healing
Time to complete ulcer healing : measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.

Full Information

First Posted
April 14, 2022
Last Updated
May 30, 2023
Sponsor
Cathay General Hospital
Collaborators
Oneness Biotech Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05338463
Brief Title
Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
Official Title
Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cathay General Hospital
Collaborators
Oneness Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is designed as a single-arm, open-label study to evaluate the efficacy and safety of Fespixon Cream for the treatment of chronic diabetic foot ulcers (DFUs) in dialysis. Twelve(12) eligible subjects with DFUs and undergoing dialysis will be enrolled and assigned to receive Fespixon treatment for 20 weeks. During the treatment phase, the Fespixon cream will be applied to the target ulcer twice a day for a maximum period of 20 weeks, until the ulcer closure (ulcer size of 0) 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 healing at the end of the treatment phase will be followed for 2 weeks. Identical standard of care (SoC) procedure will be performed throughout the study period, which including ulcer cleansing and debridement (if necessary) until complete ulcer closure. At each visit, the size and changes of the target ulcer are recorded by photographing, and calculated using Image® software. The study consists of three periods, a 2-week Screening/Run-in period, an up-to-20-week Treatment period, and a 2-week Follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diabetic Foot Ulcer
Keywords
Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A), Dialysis patients, Peripheral Arterial Occlusive Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fespixon Cream
Arm Type
Experimental
Arm Description
A single arm of Fespixon Cream for DFU (TEXAS 1A, 2A) in dialysis patients Test drug : Name : Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply twice a day Duration: up to 20 weeks
Intervention Type
Drug
Intervention Name(s)
Fespixon Cream
Other Intervention Name(s)
ON101 Cream
Intervention Description
Name : Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply twice a day Duration: up to 20 weeks
Primary Outcome Measure Information:
Title
Incidence of treatment-related Adverse Events associated with Fespixon cream
Description
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
Time Frame: 20 weeks
Secondary Outcome Measure Information:
Title
Incidence of complete healing of the target ulcer
Description
Incidence of complete healing of the target ulcer : measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Time Frame
Time Frame: 20 weeks
Title
Time to complete ulcer healing
Description
Time to complete ulcer healing : measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Time Frame
Time Frame: 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 > 2 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. Exclusion Criteria: 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 autoimmune disease therapy growth factors hyperbaric oxygen therapy bioengineered tissue or skin substitutes(ADM) application of topical steroids to the ulcer use of any investigational drug(s) A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse, determined from the subject's medical history, which, in the opinion of the investigator, may pose a threat to subject compliance. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study. Note ( Based on TEXAS 1A, 2A, the below information is to further calcification, and potential subjects meeting any of the following items will be excluded from the study.) : Ulcers with exposed bone or associated with osteomyelitis. (The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings as deemed necessary by the Investigator.) Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. Current sepsis Subjects who need to stand continuously for more than 4 hours / day and have difficulty complying with off-loading instructions. The following products and ulcer care materials should NOT be used on or around the Target Ulcer after the first Screening Visit or at any time during the Treatment Phase of the study. Topical antibiotics, antiseptic soaps, steroids, or any other topical agents on the Target Ulcer. Note: Topical medication applied to the skin surrounding the Target Ulcer is allowed. (i.e. Skin barrier prep to protect peri-wound skin.) Hydrocolloid dressings are allowed only during the screening period but are not permitted after randomization. Hydrogelsare allowed only during the screening period but are not permitted after randomization. Silver nitrate hemostatic sticks or styptic pencils Negative pressure assisted closure device Heat lamps UV lights Whirlpool baths Water Piks Hyperbaric Oxygen Jet water streams (other than gentle saline irrigation) on the leg with Target Ulcer Ulcer dressings that include growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) on all ulcers including non-target ulcers during the Treatment Phase. Revascularization surgery on the leg with Target Ulcer Systemic steroids/oral corticosteroids (NOTE: inhaled steroids are acceptable) Other Immunosuppressive agents Autoimmune disease therapies Cytostatic drugs Any other investigational treatment/medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Ming Pu, MD
Phone
886-2-2708-2121
Email
pkman9335@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Ying Lin
Phone
886-2-2708-2121
Email
sally8956236@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Ming Pu, MD
Organizational Affiliation
Cathay General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Ming Pu, MD
Phone
886-2-2708-2121
Email
pkman9335@msn.com
First Name & Middle Initial & Last Name & Degree
Jia Ying Lin
Phone
886-2-2708-2121
Email
sally8956236@gmail.com
First Name & Middle Initial & Last Name & Degree
Chi-Ming Pu, MD
First Name & Middle Initial & Last Name & Degree
Yu-Hsiu Yen, MD
First Name & Middle Initial & Last Name & Degree
Chi-Jung Huang, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IIS study

Learn more about this trial

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

We'll reach out to this number within 24 hrs