Project Title

Evaluation of a nitric oxide generating dressing (EDX) to improve management of Buruli ulcer disease

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

PRIMARY OBJECTIVES • A comparison of rate of healing of ulcers between EDX110 with oral rifampicin and clarithromycin (“EDX-RC”) and Vaseline gauze dressings with oral rifampicin and clarithromycin (“VG-RC”). SECONDARY OBJECTIVES • To compare the tolerability of the two dressings • To evaluate the relationship between treatment, the immune profile and healing in each treatment arm • To compare the rate of bacterial killing of M. ulcerans in each treatment arm EXPLORATORY OBJECTIVES • To evaluate the quality and cosmetic appearance of healing • To document healing in lesions that have not ulcerated within 2 weeks of start of treatment. • To document recurrence rate and paradoxical reactions in the two treatment arms.

Study Design

A prospective randomised open-blinded end-point (PROBE) study of EDX dressing, compared to current standard of care. The design will comply with site-specific protocols for routine best practice ulcer care using vaseline gauze dressings. The comparator will consist of EDX110 applied to the wound, combined with standard antibiotic treatment. In both groups, dressing treatment will continue until the wound has healed plus up to 7 days. The duration of antibiotic treatment will be 8 weeks.

Project Summary

The study seeks to determine the ability of EDX dressing, combined with oral rifampicin and clarithromycin, to improve healing outcomes in Buruli ulcer lesions, by comparison with the ‘Usual Care’ of oral rifampicin and clarithromycin therapy combined with standard hospital dressings (Vaseline gauze).

Host Organisation

Sites

Results & Outcomes

Current Organisation

Kwame Nkrumah University of Science and Technology

Current Job Title

Scientific Director (KCCR), Associate Professor of Medicine

Biography