Protocol summary

Summary
This is an experimental placebo controlled double blinded study. Study group is 30 identified patients who are randomly allocated in drug or placebo group. All of the patients are advised stop smoking and receive standard routine therapy of Buerger`s disease. Inclusion criteria contains: Buerger`s patients referring to Alzahra hospital who have consent of participation to study. No history of hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease or collagen vascular disease. Exclusion criteria are: surgical (sympathectomy or vascular bypass) or medical (Illeoprost or corticosteroid) changes in treatment, or starting Aspirin, calcium channel blocker, VitB6 or VitB12 or stop smoking during the study. At the start of the study demographic data, Wagner wound scale, Visual Analog Scale (VAS) of pain, Allen test, healing scale, wound size and major and minor amputation, homocysteine, anticardiolipin and number of steps walking without pain is recorded. Intervention is was one tablet containing 5 mg Folic acid and placebo (the same as color, size, and weight). The patients will be evaluate at the first , 2nd and 6th month for Homocysteine, Anticardiolipin, scale of wound, scale of pain, size of wound, major and minor amputation, sense of patient about healing and the number of steps the patient can walk without pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108012106N2
Registration date: 2011-08-04, 1390/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-04, 1390/05/13
Registrant information
Name
Afrooz Eshaghian
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7247
Email address
eshaghian@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Applied Physiology Research center, Isfahan University of Medical Science
Expected recruitment start date
2004-01-01, 1382/10/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of folic acid in Buerger`s disease on homo cysteine and clinical status
Public title
Effect of folic acid in Buerger`s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Buerger`s patients referring to Alzahra hospital who have consent of participation to study; history of smoking; onset of disease before 50 year-old; upper limb involvement or phlebitis migrants; obliterative arterial disease below popliteal artery and no risk factor of atherosclerosis except smoking; no history of hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease or collagen vascular disease. Exclusion criteria: surgical (sympathectomy or vascular bypass) or medical (Illeoprost or corticosteroid) changes in treatment; starting Aspirin, calcium channel blocker, VitB6 or VitB12 or stop smoking during the study; drug incompliance during the study and not willing to continue the study.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Mciences Eethics Committee
Street address
Isfahan University of medical sciences, Hezar Jarib St
City
Isfahan
Postal code
Approval date
2004-01-01, 1382/10/11
Ethics committee reference number
2436

Health conditions studied

1

Description of health condition studied
Buerger`s disease
ICD-10 code
I73.1
ICD-10 code description
Thromboangiitis obliterans [Buerger]

Primary outcomes

1

Description
Scale of wound
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Wagner Scale

Secondary outcomes

1

Description
Homocysteine
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Lab test

2

Description
Scale of pain
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
VAS

3

Description
Anticardiolipin
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Lab test

4

Description
Size of wound
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Millimeter

5

Description
Number of steps walkingwithout pain
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Number

6

Description
Sense of patient about healing
Timepoint
At the 2nd and 6th months
Method of measurement
Ask a patient

7

Description
Minor amputation
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Number

8

Description
Major amputation
Timepoint
At the beginnig and 2nd and 6th months
Method of measurement
Number

Intervention groups

1

Description
Intervention group will take tab. Folic acid 5 mg per day, for 6 month
Category
Treatment - Drugs

2

Description
Control group will take placebo(the same color, size, box to tab Folic acid 5 mg) one tablet per day for 6 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Applied Physiology Research Center
Full name of responsible person
Sedighe Asgari
Street address
Sofe St, Applied Physiology research center
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Applied Physiology Research Center
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
Applied Physiology Research Center
Full name of responsible person
Afrooz Eshaghian
Position
Resident of Otolaryngology
Other areas of specialty/work
Street address
Sofe st., Al-Zahra hospital
City
Isfahan
Postal code
Phone
+98 31 1236 7247
Fax
Email
eshaghian@edc.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali Akbar Beigi
Position
Assolciated professor of vascular surgery
Other areas of specialty/work
Street address
Sofe st., Al-zahra hospital
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
beigi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Applied Physiology Research center
Full name of responsible person
Afrooz Eshaghian
Position
Resident of Otolaryngolgy
Other areas of specialty/work
Street address
Sofe st., Al-Zahra hospital
City
Isfahan
Postal code
Phone
+98 31 1236 7247
Fax
Email
eshaghian@edc.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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