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Completed

NCT Number: NCT04372355

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

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.

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Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Uncontrolled Diabetes With Foot Ulcer Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HRH Princess Maha Chakri Sirindhorm Medical Center

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WF10

Drug

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

Primary outcomes

  1. HbA1c change at Week 8 in comparison to Baseline

    Time frame: 8 weeks

    The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment

Secondary outcomes

  1. HbA1c change at Week 12 in comparison to Baseline

    Time frame: 12 weeks

    The mean change of HbA1c values between Baseline (Week 0) and Week 12 after the initial WF10 treatment

Sponsors and collaborators

Lead sponsor

Srinakharinwirot University

Other

Collaborators

  • Altermed Co.,Ltd.
  • Oxo Chemie(Thailand) Co.,Ltd.

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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