Photodynamic therapy in infected venous and mixed leg ulcers: a pilot experience.

OBJECTIVE

To assess the tolerability and efficacy of photodynamic therapy (PDT) with RLP068, a novel phthalocyanine-derived photosensitiser, in controlling the bacterial load in different leg ulcers, due to vascular pathophysiology.

METHOD

An observational study of patients with infected leg ulcers of different pathophysiology, admitted to the hospital for a skin grafting procedure, were included. All patients underwent two sessions of PDT at time zero and after 72 hours. A semi-quantitative swab was taken before and 30 minutes after both sessions of PTD. During the time interval between the two treatments the ulcer was covered with foam dressing and compression therapy was applied to all patients. No systemic or topical antibiotics were administered. Statistical analysis of results was performed.

RESULTS

A total of 36 patients (13 males, 23 females; aged 72.4±8.6 years, range: 55-85 years) were recruited; two had ulcers on both legs. PDT was shown to be effective in reducing bacterial load after the first treatment. Before the second PDT treatment (72 hours after first PDT treatment), a slight increase of the bacterial load was observed in all ulcers. However, after the second PDT session, bacterial swab results were negative in all but two ulcers. The procedure was well tolerated in all but four patients, who reported a very severe pain at baseline, which increased during treatment.

CONCLUSION

In this study, PDT was effective in reducing bacterial load in patients with infected vascular leg ulcers, and allowed successful skin grafting to take place in all patients. The treatment was generally well tolerated. Studies with a greater number of patients and a control group are planned to confirm these results.