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Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients

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ClinicalTrials.gov Identifier: NCT04372355
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
Oxo Chemie(Thailand) Co.,Ltd.
Altermed Co.,Ltd.
Information provided by (Responsible Party):
Narongchai Yingsakmongkol, Srinakharinwirot University

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 4, 2020
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
HbA1c reduction at Week 8 in comparison to Baseline [ Time Frame: 8 weeks ]
The mean reduction of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
HbA1c change at Week 12 in comparison to Baseline [ Time Frame: 12 weeks ]
The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
HbA1c reduction at Week 12 in comparison to Baseline [ Time Frame: 12 weeks ]
The mean reduction of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Official Title  ICMJE Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Brief 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.
Detailed Description Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
T2DM patients with DFU and HbA1c > 8.5%
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot Ulcer (DFU)
  • Uncontrolled Diabetes With Foot Ulcer
Intervention  ICMJE Drug: WF10
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.
Other Name: Immunokine
Study Arms  ICMJE Experimental: Chlorite-based drug WF10
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
Intervention: Drug: WF10
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Narongchai Yingsakmongkol, MD, FRCST +66-81-6302610 narongchai@g.swu.ac.th
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04372355
Other Study ID Numbers  ICMJE SWUEC-043/2019F
WF10-19-THAI-01 ( Other Identifier: SWU Ethical Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Narongchai Yingsakmongkol, Srinakharinwirot University
Study Sponsor  ICMJE Srinakharinwirot University
Collaborators  ICMJE
  • Oxo Chemie(Thailand) Co.,Ltd.
  • Altermed Co.,Ltd.
Investigators  ICMJE
Principal Investigator: Narongchai Yingsakmongkol, MD, FRCST Srinakharinwirot University
PRS Account Srinakharinwirot University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP