Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease
Di Paolo N, Bocci V, Salvo DP, et al. International Journal of Artificial Organs, 2005.
- Study type
- Randomized controlled trial
- People studied
- 28 people
- Population
- Patients with peripheral artery disease
- Published
- 2005, International Journal of Artificial Organs
- Identifiers
- PMID 16288443, DOI 10.1177/039139880502801012
What the authors reported
In 28 patients with peripheral artery disease randomized to EBOO or intravenous prostacyclin, the abstract reports highly significant regression of skin lesions with EBOO, and says pain, pruritus, heavy legs and well-being differed significantly between the two groups; it found no significant change in vascularisation of the lower limbs before and after treatment in either group.
What limits this result
Small sample of 28 patients from a single Italian center; the available abstract does not describe blinding of outcome assessment or the randomization method.
Reports of the procedure as given to patients, and a review of them by its developers. Laboratory and device-development work on the circuit is under background science. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.
How the study was done
- Design
- Randomized controlled clinical trial: 28 patients with PAD randomized to EBOO or intravenous prostacyclin
- Setting
- Nephrology and Dialysis Department, University Hospital of Siena, Siena, Italy
- Read from
- Read from the abstract only; where this page says nothing about an item, the abstract does not report it. Read on September 28, 2026.
Source: Abstract on PubMed
Study arms
| Group | Participants | What they received |
|---|---|---|
| EBOO | Not reported | Extracorporeal blood oxygenation and ozonation (EBOO) |
| Intravenous prostacyclin | Not reported | Intravenous prostacyclin (comparison treatment) |
Source: Abstract on PubMed
Procedure as reported
- Sessions
- 210 EBOO treatments (per-patient schedule not stated in the abstract)
In the paper's own units, not converted.
Source: Abstract on PubMed
What it measured
- Regression of skin lesions
- Highly significant regression with EBOO compared with prostacyclin
- Pain, pruritus, heavy legs and well-being
- Significantly different between the two groups
- Vascularisation of the lower limbs, before and after treatment
- No significant differences in either group
Source: Abstract on PubMed
Safety as reported
No side effects or complications were recorded during the 210 EBOO treatments
Source: Abstract on PubMed
Where we cite this study
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