Trial | NCT04372355  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    WF10

  • Study Participants

    40
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 Started
Jun 19
2019
Primary Completion
Apr 30
2020
Study Completion
Jun 19
2020
Last Update
Oct 22
2020

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.

  • Other names: Immunokine

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

Criteria 

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.
No Results Posted