Oxygen-ozone Therapy Effective for Hard-to-treat Finger, Toe Ulcers
Targeted oxygen-ozone therapy effectively reduced digital ulcers — open sores on the fingers or toes — that had proven resistant to standard treatment in people with systemic sclerosis (SSc), a small study shows.
In this complementary treatment, an ozone/oxygen mixture is delivered to the ulcerated area via a special bag covering the affected fingers or toes.
The therapy also was found to work better than standard medication alone at improving patients’ hand mobility and their ability to perform daily activities, further supporting its use for managing hard-to-treat digital ulcers in people with SSc.
Larger studies are needed to confirm these findings and to evaluate the longer-term effects of localized oxygen-ozone therapy in this patient population, the researchers noted.
The study, “Efficacy of Local Oxygen-Ozone Therapy for the Treatment of Digital Ulcers Refractory to Medical Therapy in Systemic Sclerosis: A Randomized Controlled Study,” was published in the journal Modern Rheumatology.
SSc, also known as scleroderma, is characterized by increased inflammation, tissue scarring, and blood vessel abnormalities.
Due to poor blood flow and narrowed blood vessels, almost all SSc patients experience Raynaud’s phenomenon (RP), a condition in which the fingers and toes feel numb, prickly, and frigid in response to cold temperatures or stress.
Recurrent Raynaud’s attacks can lead to the development of digital ulcers — sores on a patient’s “digits,” or fingers and toes — which cause “local pain and functional impairment (e.g. eating and dressing), resulting in a major negative impact on quality of life,” the researchers wrote.
Such digital ulcers, which affect about 40% of SSc patients, can be difficult to manage. In severe cases, they can result in irreversible tissue death and the need for amputation of the affected fingers or toes.
A previous small study showed that non-invasive local oxygen-ozone therapy was more effective than standard vasodilator medication at reducing digital ulcer size and the associated pain of such sores, as well as lessening Raynaud’s attacks. Vasodilator therapy works by widening blood vessels.
Oxygen-ozone therapy is considered a complementary treatment, and involves the delivery of an ozone/oxygen mixture reported to have anti-microbial, antioxidant, pain-suppressing, and vasodilator effects. It also is said to regulate oxygen metabolism and immune responses.
The use of this therapy has increased in recent years due to its effectiveness in healing ulcers caused by reduced blood flow, diabetes, and external trauma in fragile areas.
However, whether oxygen-ozone therapy is effective at treating SSc-associated digital ulcers — ones resistant to standard medication — remains unclear.
To address this, a team of researchers from the Pamukkale University faculty of medicine, in Turkey, evaluated the effects of local oxygen-ozone therapy in 25 adults — 20 women and five men —with SSc. These patients each had treatment-resistant digital ulcers that had limited their ability to perform daily life activities.
Their active ulcers had not responded to at least three months of standard treatment — to include Ventavis (iloprost), endothelin receptor antagonists, phosphodiesterase 5 (PDE-5) inhibitors , calcium channel blockers, and/or low-dose aspirin.
Ventavis is an inhaled formulation of the natural hormone iloprost, given with a nebulizer, while endothelial receptor antagonists are oral medications used routinely to treat pulmonary arterial hypertension linked to scleroderma. PDE-5 inhibitors also are an oral medicine, commonly used to treat pulmonary hypertension and erectile dysfunction. Calcium channel blockers are a type of vasodilator therapy, and low-dose aspirin had been found to offer protection against some forms of cardiac disease in scleroderma patients.
The participants, who had a median age of 38, were randomly assigned to receive either oxygen-ozone therapy in addition to standard medication (13 patients) or conventional treatment alone (12 patients) for four weeks.
Non-invasive oxygen-ozone therapy, delivered in a special bag covering the ulcerated area, was given for 30 minutes every day in the first week (at a dose of 80 mg/mL), followed by two days a week in the second, third, and fourth weeks (at a dose of 40 mg/mL), for a total of 11 sessions. An “expert physician” administered the therapy, the researchers said.
The study’s main goal was to assess the proportion of patients showing any degree of ulcer healing, from any reduction in size to complete wound healing.
Secondary goals included changes in ulcer size and pain, daily number and duration of RP attacks, hand mobility — as assessed with the Modified Hand Mobility in Scleroderma — and ability to perform activities of daily living, as measured through the Health Assessment Questionnaire.
At study’s start, there were no significant differences between the groups in terms of demographic and clinical characteristics.
Results showed that a significantly greater proportion of patients given oxygen-ozone therapy exhibited ulcer reduction relative to those who received standard medication only (92% vs. 42%).
Particularly, six patients on the complementary therapy showed complete ulcer healing or a size reduction by more than half. No similar effects were observed in any of the patients on conventional treatment alone.
Also, more than half (58.3%) of those in the standard medication group showed no change in their ulcers or worsened condition, while only one patient in the complementary therapy group experienced this.
Moreover, oxygen-ozone therapy was significantly superior to conventional therapy alone at reducing ulcer pain and size, and lessening the daily number and duration of Raynaud’s attacks. It also was shown to work significantly better at improving hand mobility and general functionality.
These findings highlight that local oxygen-ozone therapy is “effective in the treatment of SSc patients with resistant [digital ulcers] and improved clinical parameters and [eased] functional disability,” the researchers wrote.
“Further longitudinal, prospective studies with larger sample sizes and long-term follow-up are warranted to evaluate the long-term results of the local oxygen-ozone therapy in patients with SSc,” the team added.