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

Diabetic Foot Ulcer (DFU) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372355
• Other study ID #: SWUEC-043/2019F
• Secondary ID: WF10-19-THAI-01
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2019
• Est. completion date: June 19, 2020

Study information

• Verified date: October 2020
• Source: Srinakharinwirot University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 19, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Thailand	HRH Princess Maha Chakri Sirindhorm Medical Center	Ongkharak	Nakhon Nayok

Sponsors (3)

Lead Sponsor	Collaborator
Srinakharinwirot University	Altermed Co.,Ltd., Oxo Chemie(Thailand) Co.,Ltd.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 weeks