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Diabetic Foot Ulcer (DFU)Phase 4NCT05438251

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

A Phase 4 study testing Fespixon Cream in people with Diabetic Foot Ulcer (DFU), run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Diabetic Foot Ulcer (DFU)
What is being tested?
Fespixon Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteTaiwan
Study dates
4 Aug 2022to 3 Apr 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • WBC ( white blood cell count ) < 4.0 X 10^9 cells/ L； > 12.0 X 10^9 cells/ L or ≥ 10% immature (band) forms.
  • Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and < 1.3, or transcutaneous pressure of oxygen (TcPO2) ≥ 30 mmHg on at least one lead to ensure no serious embolisms / no serious clogging of blood vessels.
  • Subject, if female of child-bearing potential, have a negative serum/urine 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; the study institution will provide the off-loading devices.
  • 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.

Who cannot join

  • 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
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  • 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
  • lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery)
  • 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.
  • Subjects who need to stand continuously for more than 4 hours/day and have difficulty complying with off-loading instructions.
  • Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung, 40447

Other trials in Taiwan

About this study

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).

Read the detailed description

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.

Being tested
Fespixon Cream
Keywords
ON101, Fespixon, Diabetic Foot Ulcer, TEXAS 3A/3B
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fespixon CreamDrug

    Also called ON101 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
Study groups in NCT05438251
Study groupRoleWhat they receive
Diabetic Foot Ulcers (TEXAS 3A, 3B)Experimental1. 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
Receives: Drug: Fespixon Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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."

    Measured: 12 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start4 Aug 2022
  3. Primary completion3 Apr 2024
  4. Study completion3 Apr 2024

Why it stopped: Study halted prematurely and will not resume.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Uncontrolled; Open-label; Randomized: N/A; Single Arm; Duration of treatment: up to 12 weeks; Titration: no; One-center(Taiwan)
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438251
Sponsor's protocol ID
ON101CLAS08
Status last verified
May 2024
First submitted
24 Jun 2022
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fespixon Cream in people with Diabetic Foot Ulcer (DFU), run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study halted prematurely and will not resume.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of the grade down of the target ulcer (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05438251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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