NCT03969940

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 21, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

May 23, 2019

Last Update Submit

December 17, 2020

Conditions

Buruli Ulcer

Outcome Measures

Primary Outcomes (2)

  • Primary cure: wound closure and/or no BU features according to WHO guideline

    Number of patients with wound closure and/or absence of clinically BU specific features according to WHO guidelines within 6 months after completion of heat treatment

    6 months

  • Definite cure: No recurrence

    Number of patients with no BU recurrence for 12 months after completion of heat treatment

    12 months

Secondary Outcomes (2)

  • Acceptability

    2 years

  • Acceptability

    2 years

Study Arms (2)

Thermo

Buruli ulcer patients receiving thermotherapy

Chemo

Buruli ulcer patients receiving chemotherapy

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include inhabitants of all health areas of the Akonolinga health district or coming from other BU endemic areas of Cameroon.

You may qualify if:

  • Clinically diagnosed BU patients with a single WHO category I and II lesion

You may not qualify if:

  • \- inappropriate lesion size (category III patients), location and patients with multiple lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Buruli Ulcer

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thomas Junghanss, MD

    University Hospital Heidelberg

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 31, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

December 21, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share