Ozone Therapy in Type 2 Diabetes with Diabetic Foot: A 101-Patient Randomised Controlled Trial (2005)

Background

Diabetic foot - ulcers and infections of the feet caused by the nerve and blood-vessel damage of long-standing diabetes - is one of the most serious complications of the disease and a leading cause of amputation. Oxidative stress is thought to play an important part in how diabetic complications develop.

Because earlier work had suggested that ozone can activate the body's antioxidant system and influence blood sugar and markers of blood-vessel damage, a Cuban-Italian team led by Dr Gregorio Martínez-Sánchez of the University of Havana set out to test ozone against standard antibiotic treatment in people with type 2 diabetes and diabetic foot.

Study design

This was a randomised controlled clinical trial of 101 patients. Fifty-two were treated with ozone, given both locally to the affected foot and systemically by rectal insufflation of the gas. Forty-nine were treated with topical and systemic antibiotics. Treatment lasted 20 days.

The two treatments were compared on blood sugar control, the measured area and perimeter of the lesions, and biochemical markers of oxidative stress and of damage to the cells lining the blood vessels.

This was hospital treatment of a serious condition under medical supervision. It is a description of what was studied, not a set of instructions.

Findings

In the ozone group, blood sugar control improved, oxidative stress was prevented, levels of organic peroxides returned to normal, and the antioxidant enzyme superoxide dismutase was activated.

Healing of the lesions improved in the ozone group, and there were fewer amputations than in the antibiotic group.

No side effects were reported.

The full paper is behind a paywall, so we have reported what the published abstract states and have not reproduced lesion measurements, amputation numbers or p values.

What the authors concluded

The authors attribute ozone's effect to its ability to counter superoxide, a reactive oxygen molecule they describe as a link between the main metabolic pathways involved in diabetic complications. They conclude that medical ozone could be an alternative therapy in the treatment of diabetes and its complications.

Limitations of this study

The ozone group received two things at once - local treatment of the foot and rectal insufflation - so the trial cannot say how much each contributed. Local ozone acts directly on microbes in a wound, while rectal insufflation acts through the body's own defences, and the improvement in blood sugar and antioxidant markers points to the systemic route doing real work, but the design does not separate them.

Patients and staff would have known which treatment was being given, since ozone and antibiotics cannot be disguised as each other. The blood markers and lesion measurements are less affected by this than subjective outcomes would be.

Twenty days is short for a chronic condition, and the abstract reports no longer-term follow-up. It was a single-centre trial, and the comparison was with the antibiotic treatment in use at that hospital at that time.

The authors' word "alternative" goes further than we would. Diabetic foot is a medical emergency that can threaten the limb, and infection needs prompt treatment by a medical team. Ozone therapy is a complementary approach and should only be considered alongside that care, in discussion with your doctor.

Related reading

An Overview of Ozone Therapy for Treating Foot Ulcers in Patients With Diabetes

Ozone Therapy in the Comprehensive Treatment of Diabetic Foot Syndrome

How Ozone Therapy Works: The Science in Plain Words

Martínez-Sánchez G, Al-Dalain SM, Menéndez S, Re L, Giuliani A, Candelario-Jalil E, Álvarez H, Fernández-Montequín JI, León OS. Therapeutic efficacy of ozone in patients with diabetic foot. European Journal of Pharmacology. 2005;523(1-3):151-161. doi:10.1016/j.ejphar.2005.08.020