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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer (DFU) Uncontrolled Diabetes With Foot Ulcer Drug: WF10 Phase 2

Detailed Description:
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372355


Contacts
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Contact: Narongchai Yingsakmongkol, MD, FRCST +66-81-6302610 narongchai@g.swu.ac.th

Locations
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Thailand
HRH Princess Maha Chakri Sirindhorm Medical Center Recruiting
Ongkharak, Nakhon Nayok, Thailand, 26120
Contact: Narongchai Yingsakmongkol, MD, FRCST    +66-81-6302610    narongchai@g.swu.ac.th   
Sub-Investigator: Chantra Tanunyutthawongse, MD         
Sponsors and Collaborators
Srinakharinwirot University
Oxo Chemie(Thailand) Co.,Ltd.
Altermed Co.,Ltd.
Investigators
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Principal Investigator: Narongchai Yingsakmongkol, MD, FRCST Srinakharinwirot University
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Responsible Party: Narongchai Yingsakmongkol, Associate Professor, Srinakharinwirot University
ClinicalTrials.gov Identifier: NCT04372355    
Other Study ID Numbers: SWUEC-043/2019F
WF10-19-THAI-01 ( Other Identifier: SWU Ethical Committee )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Narongchai Yingsakmongkol, Srinakharinwirot University:
DFU
WF10
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases