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| ID | Type | Description | Link |
|---|---|---|---|
| WF10-19-THAI-01 | Other Identifier | SWU Ethical Committee |
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| Name | Class |
|---|---|
| Oxo Chemie(Thailand) Co.,Ltd. | UNKNOWN |
| Altermed Co.,Ltd. | UNKNOWN |
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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.
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongchai Yingsakmongkol, MD, FRCST | Srinakharinwirot University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRH Princess Maha Chakri Sirindhorm Medical Center | Ongkharak | Changwat Nakhon Nayok | 26120 | Thailand |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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T2DM patients with DFU and HbA1c > 8.5%
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|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |