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

October 21, 2020 updated by: Narongchai Yingsakmongkol, Srinakharinwirot University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhon Nayok
      • Ongkharak, Nakhon Nayok, Thailand, 26120
        • HRH Princess Maha Chakri Sirindhorm Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Immunokine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Srinakharinwirot University

Collaborators

Oxo Chemie(Thailand) Co.,Ltd.
Altermed Co.,Ltd.

Investigators

  • Principal Investigator: Narongchai Yingsakmongkol, MD, FRCST, Srinakharinwirot University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

June 19, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWUEC-043/2019F
  • WF10-19-THAI-01 (Other Identifier: SWU Ethical Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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