Local Heat Application for the Treatment of Buruli Ulcer: Results of a Phase II Open Label Single Center Non Comparative Clinical Trial.
BACKGROUND
Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material.


METHODS
In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints 'absence of clinical BU specific features' or 'wound closure' within 6 months ("primary cure"), and 'absence of clinical recurrence within 24 month' ("definite cure").


RESULTS
Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm(2). Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions.


CONCLUSIONS
Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available.


BACKGROUND
ISRCT 72102977.
Section Clinical Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Germany.
Moritz
M
Vogel
FAIRMED, Bureau Régional pour l'Afrique, Yaoundé, Cameroon.
Pierre F
PF
Bayi
Swiss Tropical and Public Health Institute.|University of Basel, Basel.
Marie-Thérèse
MT
Ruf
Swiss Tropical and Public Health Institute.|University of Basel, Basel.
Martin W
MW
Bratschi
Swiss Tropical and Public Health Institute.|University of Basel, Basel.
Miriam
M
Bolz
FAIRMED, Bureau Régional pour l'Afrique, Yaoundé, Cameroon.
Alphonse
A
Um Boock
Institute of Social and Preventive Medicine, University of Bern, Switzerland.
Marcel
M
Zwahlen
Swiss Tropical and Public Health Institute.|University of Basel, Basel.
Gerd
G
Pluschke
Section Clinical Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Germany.
Thomas
T
Junghanss
D054312:Buruli Ulcer / Q000628:therapy*; D002163:Cameroon; D002648:Child; D005260:Female; D006358:Hot Temperature; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects / Q000379:methods*; D008297:Male; D016896:Treatment Outcome
Buruli ulcer; Mycobacterium ulcerans; local thermotherapy