Home » Trials » SLCTR/2023/022
Study to determine the effectiveness, acceptability and feasibility of thermotherapy with radio frequency – induced heat therapy (RFHT) by ThermoMed device for the local/intra lesional treatment of cutaneous leishmaniasis in selected routine clinic settings Sri Lanka.
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SLCTR Registration Number
SLCTR/2023/022
Date of Registration
The date of last modification
Jan 31, 2024
Scientific Title of Trial
Study to determine the effectiveness, acceptability and feasibility of thermotherapy with radio frequency – induced heat therapy (RFHT) by ThermoMed device for the local/intra lesional treatment of cutaneous leishmaniasis in selected routine clinic settings Sri Lanka.
Public Title of Trial
Study to determine the effectiveness, acceptability and feasibility of thermotherapy with radio frequency – induced heat therapy (RFHT) by ThermoMed device for the local/intra lesional treatment of cutaneous leishmaniasis in a selected routine clinic settings Sri Lanka.
Disease or Health Condition(s) Studied
Cutaneous Leishmaniasis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1297-9335
Any other number(s) assigned to the trial and issuing authority
EC-21-072 (ERC, Faculty of Medicine, Colombo)
What is the research question being addressed?
What is the effectiveness, acceptability and feasibility of thermotherapy by ThermoMed as treatment for cutaneous leishmaniasis in the selected routine clinics in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting(s): TH Anuradhapura and DGH Hambantota
Intervention: Thermotherapy by ThermoMedTM device will be given to patients as a single session of 50?C for 30 seconds on Day1.
No other treatment in addition to thermotherapy will be given, in accordance with the Guidelines of the College of Dermatologists of Sri Lanka.
Inclusion criteria
Exclusion criteria
1.Lesion on face or ear closer than 2cm to lip/ eye or located over cartilage.
2.Diameter les more than 4cm
3.More than or equal to 5 lesions
4.Pregnant and lactating mothers
(In accordance with the guidelines by the Sri Lanka College of Dermatologists)
(
Primary outcome(s)
|
1.
Initial cure: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 90 as compared to Day 1 and for non-ulcerated lesions as flattening and/or no signs of induration of the lesion(s) on Day 90 as compared to Day 1 |
[ At Day 90, Day 105 and Day 180 after exposure to thermotherapy ] |
|
2.
Clinical improvement: Defined for ulcerated lesions as more than or equal to 75% but less than 100% re-epithelization of the ulcer(s) at Day 90 as compared to Day 1, and for nonulcerated lesions as more than or equal to 75% but less than 100% of flattening and/ or signs of induration of the lesion(s) at Day 90 as compared to Day 1 |
[ At Day 90, Day 105 and Day 180 after exposure to thermotherapy ] |
|
3.
Late responders: Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on Day 105 compared to Day 1, and for non-ulcerated lesions as 100% of flattening and/or no signs of induration of the lesion(s) on Day 105 as compared to Day 1 |
[ At Day 90, Day 105 and Day 180 after exposure to thermotherapy ] |
|
4.
Final cure: Initial cure at Day 90 or late responders at Day 105 (if required) and no relapses by Day 180. Relapse: Lesion that achieved 100% re-epithelialization/flattening on Day 90 or Day 105 (if required) that subsequently reopened /indurated by Day 180. |
[ At Day 90, Day 105 and Day 180 after exposure to thermotherapy ] |
Secondary outcome(s)
|
1.
Acceptability and feasibility will be assessed as per the Focused Group Discussions guide. FGDs will be conducted by a sociologist. |
[ FGDs will be conducted by a sociologist on the 105th Day (+/- 10 days) follow up visit post-exposure. ] |
Target number/sample size
200
Countries of recruitment
Sri Lanka
Anticipated start date
2023-12-04
Anticipated end date
2025-12-01
Date of first enrollment
2023-12-06
Date of study completion
Recruitment status
Recruiting
Funding source
University of Colombo
Regulatory approvals
Approved by the NMRA, Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2022-08-18
Approval number
Protocol EC-21-072
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine University of Colombo P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
| Telephone: | Telephone: +94-11-2695300 ext 240 |
| Email: | Email: ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Nadira D. Karunaweera
Professor
Department of Parasitology,
Faculty of Medicine
University of Colombo
Kynsey Road, Colombo 8, Sri Lanka
+94777473190
nadira@parasit.cmb.ac.lk
Contact Person for Public Queries
Nadira D. Karunaweera
Professor
Department of Parasitology,
Faculty of Medicine
University of Colombo
Kynsey Road, Colombo 8, Sri Lanka
+94777473190
nadira@parasit.cmb.ac.lk
Primary study sponsor/organization
Faculty of Medicine, University of Colombo
No. 25, Kynsey Road, Colombo 0800
Sri Lanka
+94112695300
+94 112 691 581
https://med.cmb.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Findings of the study will be published in a peer reviewed open access journal. Individual participant data that underlie the results that will be reported and published will be made available/shared after deidentification.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
