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

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Srinakharinwirot University
• Collaborators: Altermed Co.,Ltd.; Oxo Chemie(Thailand) Co.,Ltd.

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.