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

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

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

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

Intervention / Treatment
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* Drug: WF10


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: T2DM patients with DFU and HbA1c > 8.5%
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorite-based drug WF10<br>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<br>* 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.<br>* Other names: Immunokine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU, WF10