Ozone therapy for treating foot ulcers in people with diabetes
Liu J, Zhang P, Tian J, et al. Cochrane Database of Systematic Reviews, 2015.
- Study type
- Systematic review / meta-analysis
- People studied
- 212 people, pooled from the included trials
- Population
- People with diabetic foot ulcers, pooled from 3 randomized controlled trials
- Published
- 2015, Cochrane Database of Systematic Reviews
- Identifiers
- PMID 26505864, DOI 10.1002/14651858.CD008474.pub2
What the authors reported
This Cochrane review pooled 3 small randomized trials (212 participants): one found greater ulcer-area reduction and shorter hospitalization with ozone versus antibiotics, but pooled analysis of the other two found no significant difference from usual care in ulcer healing, adverse events, or amputation rate.
What limits this result
Only three included trials, all judged at high or unclear risk of bias; the review authors conclude they are unable to draw any firm conclusions about effectiveness.
Other ozone methods, such as major autohemotherapy, that clinics cite in support of EBO2. A result for one method does not transfer automatically to another. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.
How the study was done
- Design
- Review of randomised controlled trials comparing ozone therapy with sham ozone therapy or any other interventions for foot ulcers in people with diabetes
- Setting
- Critical Care Medicine Department, The First Hospital of Lanzhou University, Lanzhou, Gansu, China (author affiliation)
- Read from
- Read from the abstract only; where this page says nothing about an item, the abstract does not report it. Read on September 29, 2026.
Source: Abstract on PubMed
What it measured
- Studies included
- Three studies (212 participants)
- Risk of bias of the included trials
- High for two trials and unclear for one
- Ozone versus antibiotics (one trial): reduction in ulcer area from baseline to the end of the study
- Greater reduction with ozone than with antibiotics: MD -20.54 cm(2), 95% CI -20.61 to -20.47
- Ozone versus antibiotics (one trial): duration of hospitalisation
- Shorter with ozone: MD -8.00 days, 95% CI -14.17 to -1.83
- Ozone versus antibiotics (one trial): number of ulcers healed over 20 days
- Did not appear to be affected: RR 1.10, 95% CI 0.87 to 1.40
- Ozone plus usual care versus usual care (two trials, meta-analysis): reduction of ulcer area and number of ulcers healed
- No evidence of a difference between groups: ulcer area MD -2.11 cm(2), 95% CI -5.29 to 1.07; ulcers healed RR 1.69, 95% CI 0.90 to 3.17
- Ozone plus usual care versus usual care (two trials, meta-analysis): adverse events and amputation rate
- Listed with the outcomes showing no evidence of a difference: adverse events RR 2.27, 95% CI 0.48 to 10.79; amputation rate RR 2.73, 95%CI 0.12, 64.42
- Authors' conclusions
- The evidence was three small RCTs with unclear methodology, so the authors are unable to draw any firm conclusions on the effectiveness of ozone therapy for diabetic foot ulcers
Source: Abstract on PubMed
Safety as reported
In the one trial of ozone versus antibiotics, no side effects were observed in either group (for the other two trials, the pooled adverse-event result is under outcomes)
Source: Abstract on PubMed
Follow-up
20 days, in the one trial of ozone versus antibiotics
Source: Abstract on PubMed
Funding and conflicts
Conflict of interest statement on PubMed: the authors have no present or past affiliations or other involvement in any organisation or entity with an interest in the outcome of the review
Source: Abstract on PubMed
Where we cite this study
Does EBO2 (EBOO) Work? The Evidence, Study by Study
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