Ozone Therapy in the Comprehensive Treatment of Diabetic Foot Syndrome

Background

Diabetic foot syndrome is one of the most serious complications of diabetes, arising from nerve damage and impaired blood flow in the feet. It can progress to deep purulent wounds and infections that are difficult to heal, and in severe cases leads to hospitalisation or amputation. Researchers in the Kabardino-Balkarian Republic (Russia) investigated whether adding ozone therapy - both intravenously and applied directly to wounds - to standard surgical treatment could improve outcomes for patients with advanced diabetic foot syndrome.

Study design

The study compared two groups of patients with severe diabetic foot syndrome (Wagner grades 3-5, indicating deep ulceration with infection or gangrene). A main group of 17 patients treated in 2016 received standard surgical treatment plus ozone therapy: 200 mL of intravenous ozone-saturated saline daily (ozone concentration 800-1000 mcg/L) alongside wound dressings soaked in ozonised saline (3.3-4 mg/L). A comparison group of 20 patients treated the year before (2015) received standard treatment alone, without ozone. The two groups were matched for age, sex and other health conditions. Researchers tracked clinical, blood (haematological), bacteriological and cytological (cell-level) measurements on days 1, 3, 5, 7 and 10 after surgery.

Findings

Patients who received ozone therapy moved from the inflammatory, tissue-damaging phase of wound healing into the regenerative (repair) phase more quickly than those on standard treatment alone. Wound swabs in the ozone group showed bacteria had been cleared by day 5, compared with day 10 or later in the comparison group. Average hospital stays were around seven days shorter in the ozone group. Blood tests in the ozone group showed faster normalisation of the erythrocyte sedimentation rate (a marker of inflammation) and a shift from elevated white blood cell and neutrophil counts towards higher lymphocyte and monocyte counts by days 3-5, both signs of a healthier immune response to infection. One patient in the study died of a pulmonary embolism, which the authors attributed to the patient's underlying condition rather than to ozone treatment.

What the authors concluded

The authors concluded that adding intravenous and topical ozone therapy to standard surgical care produced a clear therapeutic benefit for patients with severe diabetic foot syndrome - speeding wound healing, reducing markers of systemic toxicity (endotoxicosis), and shortening hospital stays. They noted that the approach is straightforward to apply, does not require specialised equipment beyond an ozone generator, and is inexpensive relative to the potential savings from shorter admissions.

Limitations of this study

This was a small study (37 patients in total) conducted at a single centre. Rather than randomising patients to treatment or control, the researchers compared a 2016 treatment group against a 2015 historical comparison group treated the year before, which leaves room for other differences between the years (such as changes in surgical practice) to have influenced results. There was no blinding of clinicians or outcome assessors, and follow-up was limited to the first 10 days after surgery, so longer-term healing and amputation rates were not reported. Larger, ideally randomised and multi-centre studies would be needed to confirm these findings.