A comparative investigation of therapeutic effect ND yag laser on small vascular lesions on the lower limbs with energy of 160-180 and pulse duration of 50 with respect to energy 120-140 and pulse duration 10
Using the results of this study, we can help treat lower limb vascular lesions with ND yag laser.
Design
A clinical trial with a control group, with parallel groups, double-blind (patient, analyzer and evaluator) as a computer block randomized by SPSS software and phase 2 is performed on 37 patients. In this way, if both lower limbs are involved, one limb is randomly lasered with an energy of 160-180 and a pulse of 50 and the other limb with an energy of 120-140 and a pulse of 10. But if only one limb is involved, based on the medial and lateral of that limb, the mentioned energy and pulse are given randomly.
Settings and conduct
The first session is patient selection and sono Doppler and then the first laser session(Randomly energy 120-140 and pulse 10 versus energy 160-180 and pulse 50)
Second session (2 months later) Evaluate the response and perform the second laser session(same energy and pulse of their first session)
Third session (2 months later second session) Final evaluation(Based on response to treatment)
Location: Razi Hospital Laser Clinic
Double-blind RCT (patient, statistical analyzer, assessor)
Participants/Inclusion and exclusion criteria
37patients
Inclusion: Having a vascular lesions both above and below the knee; signing an inform consent; vascular lesions smaller than 3 mm.
Exclusion: Having a history of arterial and venous thrombosis; active infection on the area of laser; history of liver cirrhosis or consumption of ocp; vascular lesion only on one side of the knee; history of laser or sclerotherapy during the past 6 months; Pregnancy; skin types 5 and 6; history of sunburn; lactation.
Intervention groups
Patients with small vascular lesions of lower limb referred to the laser clinic of Razi Hospital in Tehran 1400-1401
Main outcome variables
Age; sex; family history; skin type; location; size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053262N1
Registration date:2022-09-19, 1401/06/28
Registration timing:registered_while_recruiting
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Ehsan Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7716 4487
Email address
www.esirost65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-04, 1401/03/14
Expected recruitment end date
2022-10-06, 1401/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative investigation of therapeutic effect ND yag laser on small vascular lesions on the lower limbs with energy of 160-180 and pulse duration of 50 with respect to energy 120-140 and pulse duration 10
Public title
Evaluation of the effectiveness of ND yag laser on small vascular lesions on lower limb with different energy and pulse duration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intact perforating & deep vessels in ultrasound
No active infection of the laser area
signing an inform consent
No history of arterial & venous thrombosis of the lower extremities
The Presence of vascular lesions <3 mm
having a vascular lesion both above and below the knee
No history of liver cirrhosis
No history of laser and sclerotherapy in the area in the last 6 months
No history of sunburn
No consumption ocp
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Blocks 4, 6 and 8, in which there are equal numbers of each group in each block, are used to create a balance in the number of assigned samples of each of the studied groups.
Randomization unit: Cluster. For this purpose, people are clustered in groups, then sampled from clusters, and it is used when it is possible to select a group of people and it is easier than selecting people in one The community is defined.
We do not have random layering.
Randomization tool: statistical software SAS(Statistical Analysis System)
Random allocation concealment prevents the disclosure of a random sequence so that the assigned group is not specified prior to the individual allocation. This study is two-blind (patient, assessor, statistical analyzer).
Blinding (investigator's opinion)
Double blinded
Blinding description
ِDouble blind: Participant, Data analyzer, Assessor
The participant will not be informed of the result of the assessor and statistical analyzer during the study.
The analyzer does not know how to divide the two groups and the type of treatment.
The assessor does not know how to divide the two groups and the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 533, Razi Dermatology Hospital, Vahdat Islami St., Tehran town
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1073
Health conditions studied
1
Description of health condition studied
lower limb vascular lesions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vascular lesions recovery rate
Timepoint
Before laser onset, 2 months later, 4 months after initial examination
Method of measurement
Caliper, photography
Secondary outcomes
1
Description
1. Help improve superficial varicose veins and prevent them from becoming deep varicose veins 2.Giving a better appearance to patient,s feet 3. Reduce patient anxiety and improve quality of life
Timepoint
Onset, 2 months later, 4 months later
Method of measurement
Photography, caliper
Intervention groups
1
Description
Intervention group: Vascular lesions of less than 3 mm of the lower limb are treated by laser ND yag with energy 160-180 and pulse duration 50 during 0&2 months .
Category
Treatment - Other
2
Description
Control group: Vascular lesions of less than 3mm of the lower limb are treated by laser ND yag with energy 120-140 and pulse duration10 during 0 &2 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Ehsan Rostami
Street address
No 17, Abadi street, north Nabard, Piroozi, Tehran town
City
Tehran
Province
Tehran
Postal code
1766637531
Phone
+98 21 7716 4487
Email
EsiRost65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razi hospital Laser Center
Street address
No. 533, Razi Dermatology Hospital, Vahdat Islami St., Tehran town
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
razihospital@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rostami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 17, Abadi street, north Nabard, Piroozi, Tehran town
City
Tehran
Province
Tehran
Postal code
1766637531
Phone
0021 77164487
Email
EsiRost65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rostami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.17, Abadi street, north Nabard, Piroozi, Tehran town
City
Tehran
Province
Tehran
Postal code
1766637531
Phone
+98 21 7716 4487
Email
EsiRost65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rostami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.17, Abadi street, north Nabard, Piroozi, Tehran town
City
Tehran
Province
Tehran
Postal code
1766637531
Phone
+98 21 7716 4487
Email
EsiRost65@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All patient information can be shared without mentioning the name.
When the data will become available and for how long
From 6 months after the end of the study until forever
To whom data/document is available
Researchers, experts in the field of laser industry and Dermatologists
Under which criteria data/document could be used
For scientific studies and therapeutic applications
From where data/document is obtainable
medical University Tehran
What processes are involved for a request to access data/document
By sending an email to Tehran university of Medical sciences and after reviewing the action is done