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

Srinakharinwirot University

Status and phase: Completed; Phase 2

Conditions: Uncontrolled Diabetes With Foot Ulcer; Diabetic Foot Ulcer (DFU)

Treatments: Drug: WF10

Study type: Interventional

Funder types: Other

Identifiers

NCT04372355

SWUEC-043/2019F

WF10-19-THAI-01 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Chlorite-based drug WF10

Experimental group

Description:

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

Treatment:

Drug: WF10