Chronic Diabetic Foot UlcerPhase 4NCT05338463
Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
A Phase 4 study testing Fespixon Cream in people with Chronic Diabetic Foot Ulcer, run by Cathay General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Diabetic Foot Ulcer
- What is being tested?
- Fespixon Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 22 Mar 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%.
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
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.
Read the 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.
- Conditions
- Chronic Diabetic Foot Ulcer
- Being tested
- Fespixon Cream
- Keywords
- Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A), Dialysis patients, Peripheral Arterial Occlusive Disease
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fespixon Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: 20 weeks
Secondary outcomes (2)
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.
Measured: Time Frame: 20 weeks
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.
Measured: Time Frame: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Dec 2021
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oneness Biotech Co., Ltd.
- Responsible party
- Principal investigator, Chi-Ming Pu, Cathay General Hospital
- Investigators
- Chi-Ming Pu, MD, Principal investigator, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338463
- Sponsor's protocol ID
- ON101CLAS06
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IIS study
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
- ClinicalTrials.gov ID
- NCT05338463
- Acronym / sponsor ID
- ON101CLAS06
- Conditions
- Chronic Diabetic Foot Ulcer
- Keywords
- Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A), Dialysis patients, Peripheral Arterial Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Collaborators
- Oneness Biotech Co., Ltd.
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Fespixon Cream | Experimental | Drug: Fespixon CreamA 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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. .
Key exclusion criteria (48 listed)
- 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:
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fespixon CreamAlso: ON101 Cream1. 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 |
Primary outcome
Incidence of treatment-related Adverse Events associated with Fespixon cream
Time frame: Time Frame: 20 weeks
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
2 secondary outcomes
Incidence of complete healing of the target ulcer
Time frame: Time Frame: 20 weeks
Time to complete ulcer healing
Time frame: Time Frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No. IIS study
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Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
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RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Ming Pu, MD principal investigator
Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fespixon Cream in people with Chronic Diabetic Foot Ulcer, run by Cathay General Hospital 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 15 inclusion and 48 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: finished, as of the sponsor's last update on 3 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 treatment-related Adverse Events associated with Fespixon cream (time frame: Time Frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.