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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04372355

Enrollment

Registered

2020-05-04

Start date

2019-06-19

Completion date

2020-06-19

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer (DFU), Uncontrolled Diabetes With Foot Ulcer

Keywords

DFU, WF10

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 HbA1c levels at baseline and after treatment.

Detailed description

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

Interventions

DRUGWF10

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

T2DM patients with DFU and HbA1c \> 8.5%

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
HbA1c change at Week 8 in comparison to Baseline	8 weeks	The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment

Secondary

Measure	Time frame	Description
HbA1c change at Week 12 in comparison to Baseline	12 weeks	The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026