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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer (DFU); Uncontrolled Diabetes With Foot Ulcer
• Interventions: Drug: WF10

• Registration Number: NCT04372355
• Lead Sponsor: Srinakharinwirot University

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

Study Timeline

• Study Start: 2019-06-19
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Primary Completion: 2020-04-30
• Study First Posted: 2020-05-04
• Study Completion: 2020-06-19
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorite-based drug WF10	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

Primary Outcome Measures

Name	Time	Method
HbA1c change at Week 8 in comparison to Baseline	8 weeks	The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c change at Week 12 in comparison to Baseline	12 weeks	The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment

Trial Locations

Locations (1)

HRH Princess Maha Chakri Sirindhorm Medical Center; 🇹🇭 Ongkharak, Nakhon Nayok, Thailand