Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

NCT05977309 | Completed DMC

• 1 other identifier: UHarapanBangsa
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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 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

Keywords

ozone; wound healing; diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Comparison of the effects of topical ozone therapy and placebo on the healing of diabetic foot ulcers.

  Comparing the healing of diabetic foot ulcers in the topical ozone therapy group with the control group. The dimensions of a wound can be assessed for wound-healing purposes by employing a photographic apparatus to quantify the length and width of the wound.

  Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began.

Secondary Outcomes (3)

• Comparison of ischemia to variations in skin oxygen levels by transcutaneous oxygenation (TcPO2) assessment of topical ozone therapy and placebo in diabetic foot ulcers

  Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began.

• Comparison of improvement in peripheral microcirculation from ischemia in diabetic foot ulcers between topical ozone therapy and a control group using the toe ankle-brachial index (TBI) measurement.

  Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began.

• Comparison of topical ozone therapy and placebo groups for diabetic foot ulcer infection

  Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began

Study Arms (2)

Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

EXPERIMENTAL

The topical ozone therapy group received standard wound care with modern dressings every three days for thirty days.

Device: Topical ozone therapy

Effect of Standart Wound Care on The Healing Diabetic Foot Ulcer

PLACEBO COMPARATOR

The placebo group received standard wound care with modern dressings thrice weekly for thirty days.

Device: Topical ozone therapy

Interventions

Topical ozone therapy DEVICE

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.

Also known as: ozone therapy

Effect of Standart Wound Care on The Healing Diabetic Foot Ulcer; Effect of Topical Ozone on The Healing Diabetic Foot Ulcer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Asmat Burhan: lead

Study Sites (1)

Griya Husada Clinic

Kediri, Indonesia, 64118, Indonesia

Location

Related Links

• Diabetic foot ulcer is one of the common complications of diabetes disease that is costly and difficult to treat.
• New classification system for the threatened lower limb, based on the three main factors that have an impact on limb amputation risk: Wound (W), Ischemia (I) and foot Infection ("fI").
• DFU patients in the gangrenous stage have a high risk of amputation.
• DFU treatment costs the healthcare system and the patient's family a lot.
• Clinical studies have provided evidence on the oxygen-ozone therapy effectiveness in low perfusion syndromes and hyperglycemia, as well as conditions with oxidative stress and inflammation. The oxygen-ozone therapy promotes faster recovery and enhances h
• ozone administration can induce tolerance to oxidative stress and prevent free radical-mediated injury
• Diabetic foot ulcer patients have a high mortality rate of almost 50% within 5 years with one of the causes being infection

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Asmat Burhan, MSN

  Universitas of Harapan Bangsa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were randomly assigned to ozone therapy and placebo groups in a ratio of 1:1 using block randomization with Random Allocation Software (RAS) and block sizes of 4 and 6. By the number of samples, envelopes were prepared, and capsules were deposited within them. 1 to 430 were assigned to each envelope. The envelopes were opened in the order that the participants entered the study, and the type of intervention was determined. A person uninvolved in the sampling process prepared envelopes in the allocation order. In this study, researchers, subjects, and outcome evaluators were all blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Researcher in Nursing, Faculty of Health Sciences, Universitas Harapan Bangsa

Model Details: In five wound care clinics on Java Island, Indonesia, 430 men and women with diabetic foot ulcer lesions participated in this randomised, triple-blind clinical trial. Inclusion criteria included women and men receiving treatment for diabetic foot ulcers, the Wagner scale, current blood sugar between 120 and 180 mg/dl, Hb1ac between 4.5 and 7%, lesion length greater than 5 cm, and infection. Exclusion criteria in this investigation, such as immunodeficiency disorders, are listed as examples.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 4, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)