Effect of Topical Ozone on The Healing Diabetic Foot Ulcer (NCT05977309) | Clinical Trial Compass
CompletedNot Applicable
Effect of Topical Ozone on The Healing Diabetic Foot Ulcer
Indonesia430 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the effects of topical ozone therapy and placebo on the healing of diabetic foot ulcers.
Timeframe: Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began.