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Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

NCT05977309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-02-17

No results posted yet for this study

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 ozone therapy. Reported no significant impact on the healing process of DFU, and not all said that topical ozone can enhance the healing process. This study aimed to compare the efficacy of topical ozone therapy in conjunction with standard wound care versus routine wound care alone in treating DFU. The wound, ischemia, and foot infection (WIFI) scale was used to measure wound size, the tissue survival rate at DFU, infection, peripheral microcirculation, glycemic control, Hba1c control, and wound healing.

Conditions

  • Wound Heal
  • Diabetic Foot Ulcer
  • Ozone

Interventions

DEVICE

Topical ozone therapy

the topical ozone therapy group received a concentration of 30 mg/L at a frequency of 30 minutes per day for 30 days. Participants received ozone therapy topically every three days for eight treatments.

Sponsors & Collaborators

  • Asmat Burhan

    lead OTHER

Principal Investigators

  • Asmat Burhan, MSN · Universitas of Harapan Bangsa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05977309 on ClinicalTrials.gov