Status:
COMPLETED
Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Lead Sponsor:
Srinakharinwirot University
Collaborating Sponsors:
Oxo Chemie(Thailand) Co.,Ltd.
Altermed Co.,Ltd.
Conditions:
Diabetic Foot Ulcer (DFU)
Uncontrolled Diabetes With Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 HbA1...
Detailed Description
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04372355
Start Date
June 19 2019
End Date
June 19 2020
Last Update
October 22 2020
Active Locations (1)
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1
HRH Princess Maha Chakri Sirindhorm Medical Center
Ongkharak, Changwat Nakhon Nayok, Thailand, 26120