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

Primary Purpose

Diabetic Foot Ulcer (DFU), Uncontrolled Diabetes With Foot Ulcer

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

WF10

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer (DFU) focused on measuring DFU, WF10

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

HRH Princess Maha Chakri Sirindhorm Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chlorite-based drug WF10

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04372355

First Posted

April 29, 2020

Last Updated

October 21, 2020

Sponsor

Srinakharinwirot University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04372355

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

June 19, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

June 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Srinakharinwirot University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer (DFU), Uncontrolled Diabetes With Foot Ulcer

Keywords

DFU, WF10

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

T2DM patients with DFU and HbA1c > 8.5%

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chlorite-based drug WF10

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

WF10

Other Intervention Name(s)

Immunokine

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1c change at Week 8 in comparison to Baseline

Description

The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

HbA1c change at Week 12 in comparison to Baseline

Description

The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Narongchai Yingsakmongkol, MD, FRCST

Organizational Affiliation

Srinakharinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

HRH Princess Maha Chakri Sirindhorm Medical Center

City

Ongkharak

State/Province

Nakhon Nayok

ZIP/Postal Code

26120

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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