Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03969940 |
Other study ID # |
2018-13 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
June 30, 2020 |
Study information
Verified date |
November 2020 |
Source |
Swiss Tropical & Public Health Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with
heat packs and WHO recommended wound management in a BU endemic district of Cameroon.
Description:
The project translates available clinical research findings at the secondary health care
level into clinical practice at the primary health care and community level. The string of
previous work from the development of the BU thermotherapy-wound management-package to the
proof of its efficacy provides all necessary procedures, tools and documents to immediately
proceed into practical and integrated community application.
Main objective:
To determine in patients with early BU lesions the effectiveness and acceptability of
thermotherapy treatment at health post and community level.
Specific objectives:
1. To monitor and evaluate clinical and biological responses to thermotherapy in patients
receiving up to 8 weeks of thermotherapy
2. To assess within 6 months after completion of heat treatment wound closure ("primary
cure") and/or absence of BU specific features in included patients according to WHO
healing criteria
3. To measure the BU recurrence rate in included patient within 12 months after completion
of heat treatment' ("definite cure").
4. To assess the compliance rate of included patients
5. To assess the withdrawal rate of included patients
6. To assess the ability and comfort of health personnel to use the thermotherapy device