Status:

COMPLETED

Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

Lead Sponsor:

Asmat Burhan

Conditions:

Wound Heal

Diabetic Foot Ulcer

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Despite conflicting and contradictory evidence regarding its efficacy, some wound care centres have advocated and adopted ozone for treating DFU. However, there are gaps in the application of topical ...

Detailed Description

Diabetic foot ulcer (DFU) is one of the most severe complications that diabetic patients can develop (1). The lifetime incidence of DFUs is estimated to range between 19% and 34%, and between 40% and ...

Eligibility Criteria

Inclusion

  • Inclusion standarts:
  • Patients with diabetic foot ulcers, both male and female, include both sexes.
  • Size wound 4-80cm
  • Value toe brachial index between 4-7 mmHg
  • Value transcutaneous oxygen (TcPO2) levels range 1-45 mmHg
  • Infection, area of cellulitis 1-2cm
  • Exclusion standarts:
  • Immunodeficiency conditions
  • Concurent ilness
  • Size wound \>80cm
  • Value toe brachial index (TBI) \<4 mmHg
  • Value crititcal for transcutaneous oxygen (TcPO2) is 0 mmHg
  • Systemic infection and sepsis

Exclusion

    Key Trial Info

    Start Date :

    August 1 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 30 2023

    Estimated Enrollment :

    430 Patients enrolled

    Trial Details

    Trial ID

    NCT05977309

    Start Date

    August 1 2023

    End Date

    August 30 2023

    Last Update

    November 17 2025

    Active Locations (1)

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    1

    Griya Husada Clinic

    Kediri, Indonesia, Indonesia, 64118