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

NCT04372355 | Completed Phase 2

• 2 other identifiers: SWUEC-043/2019FWF10-19-THAI-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DFU; WF10

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• HbA1c change at Week 12 in comparison to Baseline

  12 weeks

Study Arms (1)

Chlorite-based drug WF10

EXPERIMENTAL

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

Interventions

WF10 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.

Also known as: Immunokine

Chlorite-based drug WF10

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Srinakharinwirot University: lead
• Oxo Chemie(Thailand) Co.,Ltd.: collaborator
• Altermed Co.,Ltd.: collaborator

Study Sites (1)

HRH Princess Maha Chakri Sirindhorm Medical Center

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Narongchai Yingsakmongkol, MD, FRCST

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: T2DM patients with DFU and HbA1c \> 8.5%

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: June 19, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 19, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)