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Evaluation of Microwave Thermotherapy versus Intralesional Antimonial in Treatment of Cutaneous Leishmaniasis

Protocol summary

Study aim
Determination of the Effectiveness of Local Thermotherapy by Microwave Method Compared to Intralesional Injection in Patients with Cutaneous Leishmaniasis
Design
In the intervention group, Microwave Thermotherapy was performed for 15 minutes with a distance of 2 cm from the outlet wound 60 watts twice a week to 12 sessions. In the control group, intra-lesional antimonial was injected as prescribed by the National Committee for leishmaniasis (8-12 sessions). Simple randomization.sample size is the pilot .
Settings and conduct
In this study, patients who come to Imam Reza Hospital and Ghaem Hospital and the Center for Health ab va bargh in 1397-98, are admitted to the study by maintaining entry and exit criteria and obtaining informed consent.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Diagnosis by smear or biopsy of skin lesions has been approved, failure to receive an effective medication in the treatment of leishmaniasis in a month ago, patient's informed consent, and the signing of written consent.
Intervention groups
In the intervention group, microwave therapy was performed for 15 minutes at intervals of 2 cm with 60 watts twice a week, up to 12 sessions.
Main outcome variables
The induration and size of the lesion before and after the treatment, as well as 3 months and 6 months and one year after treatment, the percentage of patients / lesions improved at the end of the third month, the rate of improvement, the severity of the pain in each group, the severity of the pain in each group, Scare rate in the last review.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181012041313N1
Registration date: 2019-04-03, 1398/01/14
Registration timing: registered_while_recruiting

Last update: 2019-04-03, 1398/01/14
Update count: 0
Registration date
2019-04-03, 1398/01/14
Registrant information
Name
Naeime Ebrahimabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3509 8109
Email address
ebrahimabadin961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-23, 1397/12/04
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Microwave Thermotherapy versus Intralesional Antimonial in Treatment of Cutaneous Leishmaniasis
Public title
Evaluation of Microwave Thermotherapy versus Intralesional Antimonial in Treatment of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis by smear or biopsy of skin lesions is confirmed lack of effective medication in the treatment of leishmaniasis in a month ago patient's informed consent the signing of written consent.
Exclusion criteria:
Infectious or ulcerative lesions, inappropriate patient cooperation patient's desire to withdraw from study. pregnancy and lactation. secondary infection based on clinical presentation lesions near eye nerves and Testis having a pacemaker and prosthesis at the treatment site very extensive lesions (more than 10 centimeters) patients with sporotrichoid lesions chronic diseases such as diabetes mellitus and peripheral neuropathy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple. This method use simple randomization models such as tossup, the use of a random number table, or the use of computer randomization methods. And any one who refers,puts in the intervention or control group, for example, dropping a coin, flip. The implementation of this method is very simple. The disadvantages of this method are that the sample size of a group may be more than the other. One type of intervention may be given early in the study and a type of intervention late in the study. Between patients who have entry and exit conditions draw and randomly select individuals and we add the intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessors and analysts are unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil Abad Highway-Azadi Square-Pardis University-Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.707

Health conditions studied

1

Description of health condition studied
leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Induration of lesion
Timepoint
Before and after treatment, as well as 3 months and 6 months and one year after treatment
Method of measurement
ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Microwave Thermotherapy for 15 minutes with a distance of 2 centimeters from the wound site at 60 watts twice a week, up to 12 sessions.
Category
Treatment - Devices

2

Description
Control group: In the control group, intra-lung antimyelial injection was performed according to the instructions of the State Committee for Sickle (8-12 sessions).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Imam Reza and Ghaem Hospital and Ab V Bargh Center
Full name of responsible person
Masoud Maleki
Street address
Shariati Square, Imam Reza Hospital (AS)
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
MalekiM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakil Abad Highway-Azadi Square-Pardis University-Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Email
MalekiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Maleki
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vakil Abad Highway-Azadi Square-Pardis University-Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 0513882856
Email
MalekiM@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Maleki
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vakil Abad Highway-Azadi Square-Pardis University-Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8560
Email
MalekiM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naeimeh Ebrahimabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shariati Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3509 8109
Email
EbrahimAbadiN961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The consent of the participants is subject to the non-publication of their information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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