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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
HRH Princess Maha Chakri Sirindhorm Medical Center
Ongkharak, Changwat Nakhon Nayok, Thailand
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
Time frame: 8 weeks
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
Time frame: 12 weeks
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