Phase Change Material for Thermotherapy of Buruli Ulcer: A Prospective Observational Single Centre Proof-of-Principle Trial

BACKGROUND Buruli ulcer (BU) is an infection of the subcutaneous tissue leading to chronic necrotizing skin ulcers. The causative pathogen, Mycobacterium ulcerans, grows best at 30 degrees C-33 degrees C and not above 37 degrees C. We explored the safety, tolerability and efficacy of phase change material (PCM), a novel heat application system for thermotherapy of BU. METHODOLOGY/PRINCIPAL FINDINGS In a prospective observational single centre proof-of-principle trial in Ayos/Cameroon, six laboratory reconfirmed patients with ulcerative Buruli lesions received 28-31 (ulcers < or = 2 cm) or 50-55 (ulcers > 2 cm) days of thermotherapy with the PCM sodium acetate trihydrate as heat application system. This PCM is widely used in commercial pocket heat pads, it is easy to apply, rechargeable in hot water, non-toxic and non-hazardous to the environment. All patients enrolled in the trial completed treatment. Being completely mobile during the well-tolerated heat application, acceptability of the PCM bandages was very high. In patients with smaller ulcers, wounds healed completely without further intervention. Patients with large defects had skin grafting after successful heat treatment. Heat treatment was not associated with marked increases in local inflammation or the development of ectopic lymphoid tissue. One and a half years after completion of treatment, all patients are relapse-free. CONCLUSIONS/SIGNIFICANCE Our reusable PCM-based heat application device appears perfectly suited to treat BU in endemic countries with limited resources and infrastructure. TRIAL REGISTRATION Controlled-Trials.com ISRCTN88392614.