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

NCT ID: NCT04372355

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2020-06-19

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

WF10

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Immunokine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxo Chemie(Thailand) Co.,Ltd.

UNKNOWN

Sponsor Role: collaborator

Altermed Co.,Ltd.

UNKNOWN

Sponsor Role: collaborator

Srinakharinwirot University

OTHER

Sponsor Role: lead

Responsible Party

Narongchai Yingsakmongkol

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narongchai Yingsakmongkol, MD, FRCST

Role: PRINCIPAL_INVESTIGATOR

Srinakharinwirot University

Locations

HRH Princess Maha Chakri Sirindhorm Medical Center

Ongkharak, Changwat Nakhon Nayok, Thailand

Countries

Thailand

Other Identifiers

WF10-19-THAI-01

Identifier Type: OTHER

Identifier Source: secondary_id

SWUEC-043/2019F

Identifier Type: -

Identifier Source: org_study_id