Diabetic Foot Ulcer (DFU)Phase 2NCT04372355
Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
A Phase 2 study testing WF10 in people with Diabetic Foot Ulcer (DFU) and Uncontrolled Diabetes With Foot Ulcer, run by Srinakharinwirot University at 1 site in Thailand.
Trial summary
Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Uncontrolled Diabetes With Foot Ulcer
- What is being tested?
- WF10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 19 Jun 2019to 19 Jun 2020
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Diabetes Mellitus type II
- Patient male or female 18-80 years old
- Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4
- HbA1c > 8.5%
- Hematocrit > 30%
Who cannot join
- Kanofsky performance status < 60
- Patient with ABI (Ankle Brachial index) < 0.4
- Patient who receive steroid ,chemotherapeutic drug
- Pregnant or lactating woman
- Patient had a history of organ transplantation, and using immunosuppressive drug
- Patient with end-stage renal disease requiring hemodialysis, or history of G6PD or severe thalassemia, or ischemic heart disease, Congestive heart failure, Heart arrhythmia
- Patient who is participating in another clinical study or have done it in the past 30 days.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
HRH Princess Maha Chakri Sirindhorm Medical Center
Ongkharak, Changwat Nakhon Nayok, 26120
About this study
Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment.
Read the detailed description
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
- Being tested
- WF10
- Keywords
- DFU, WF10
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WF10Drug
Also called Immunokine
WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five subsequent weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chlorite-based drug WF10 | Experimental | WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five Receives: Drug: WF10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change at Week 8 in comparison to Baseline
The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment
Measured: 8 weeks
Secondary outcomes (1)
HbA1c change at Week 12 in comparison to Baseline
The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start19 Jun 2019
- Primary completion30 Apr 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- T2DM patients with DFU and HbA1c \> 8.5%
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Collaborators
- Oxo Chemie(Thailand) Co.,Ltd., Altermed Co.,Ltd.
- Responsible party
- Principal investigator, Narongchai Yingsakmongkol, Srinakharinwirot University
- Investigators
- Narongchai Yingsakmongkol, MD, FRCST, Principal investigator, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372355
- Sponsor's protocol ID
- SWUEC-043/2019F
- Other IDs
- WF10-19-THAI-01
- Status last verified
- Oct 2020
- First submitted
- 29 Apr 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
- ClinicalTrials.gov ID
- NCT04372355
- Acronym / sponsor ID
- SWUEC-043/2019F
- Keywords
- DFU, WF10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Collaborators
- Oxo Chemie(Thailand) Co.,Ltd., Altermed Co.,Ltd.
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 4 May 2020 (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.
Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment.
Detailed description
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- T2DM patients with DFU and HbA1c > 8.5%
| Arm | Type | Receives |
|---|---|---|
| Chlorite-based drug WF10 | Experimental | Drug: WF10WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Diabetes Mellitus type II
- Patient male or female 18-80 years old
- Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4
- HbA1c > 8.5%
- Hematocrit > 30%
Key exclusion criteria (7 listed)
- Kanofsky performance status < 60
- Patient with ABI (Ankle Brachial index) < 0.4
- Patient who receive steroid ,chemotherapeutic drug
- Pregnant or lactating woman
- Patient had a history of organ transplantation, and using immunosuppressive drug
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 |
|---|---|---|
| WF10Also: ImmunokineWF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five subsequent weeks. | Drug | Chlorite-based drug WF10 |
Primary outcome
HbA1c change at Week 8 in comparison to Baseline
Time frame: 8 weeks
The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment
1 secondary outcome
HbA1c change at Week 12 in comparison to Baseline
Time frame: 12 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 22 Oct 2020.
- Individual participant dataSharing planned: No
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Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg 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.
Narongchai Yingsakmongkol, MD, FRCST principal investigator
Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WF10 in people with Diabetic Foot Ulcer (DFU) and Uncontrolled Diabetes With Foot Ulcer, run by Srinakharinwirot University at 1 site in Thailand.
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 5 inclusion and 7 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 22 Oct 2020. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HbA1c change at Week 8 in comparison to Baseline (time frame: 8 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 22 Oct 2020.