The aim of this study is to evaluate the therapeutic effects of diathermy (thermotherapy) on skin lesions of cutaneous leishmaniasis. Thirty five cases of cutaneous leishmaniasis with less than six months of duration, diagnosed by direct positive smear, would be enrolled to study. The therapeutic intervention is thermotherapy by microwave and short wave infra-red; 3 sessions per week until 4-6 weeks (each session include 45 0C for 10 minutes). Lesion size changes will be recorded during treatment period and finally the results will be classified as complete improvement (90-100%), good improvement (70-90%), moderate improvement (50-70%) and no response (below 50%). Also the patients will be visited 6 weeks after the last therapeutic intervention to assess the lesion status and likely side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903183862N5
Registration date:2010-06-08, 1389/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-08, 1389/03/18
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2007-10-16, 1386/07/24
Expected recruitment end date
2010-08-18, 1389/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of thermotherapy in treatment of patients with cutaneous leishmaniasis
Public title
Evaluating the effects of thermotherapy on cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: confirmed cutaneous leishmaniasis by direct smear, less than 6 months of clinical duration, ulcer size less than 1 cm that limits topical application thermotherapy, signing of inform consent form for using this treatment modalities. Exclusion criteria: presence of lesion in sensitive sites to thermotherapy, patients who under simultaneous treatment for cutaneous leishmaniasis.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences, Mashad,
City
Mashhad
Postal code
Approval date
2007-04-08, 1386/01/19
Ethics committee reference number
6209
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
lesion healing
Timepoint
weekly
Method of measurement
measuring the size of induration and ulcer by caliper
Secondary outcomes
1
Description
side effect
Timepoint
weekly
Method of measurement
clinical evaluation
Intervention groups
1
Description
Thermotherapy: 4 to 6 weeks (3 times weekly - ten minutes each time)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for skin diseae and cutaneous leishmaniasis
Full name of responsible person
Dr Vahid Mashayekhi
Street address
Dermatology Department, Imam Reza Hospital, Avicennia street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for Research
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Scinences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and leishmaniasis, Office building, Ahmad Abad Street, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology, Imam Reza Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Vahid Mashayekhi Ghoyonlo
Position
Assistant professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Imam Reza Hospital, Avicenna Street, Imam Reza square
City
Mashhad
Postal code
Phone
+98 51 1802 2490
Fax
Email
mashayekhiv@mums.ac.ir , vahid4706@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center for skin disease and cutaneous leihmaniasis, Ghaem Hospital, Mashhad Medical Univers
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences, Biologist
Other areas of specialty/work
Street address
research center of skin diseases and leishmaniasis, Office building, Ahmad Abad Street, Ghaem Hospital
City
Mashhad
Postal code
Phone
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)