To determine the effect of Pentoxifylline in the treatment of chronic venous ulcers, 40 Chronic venous ulcers patients at the vascular clinic visit of Shahid Rajaee hospital, Gazvin-Iran, are randomly divided into two groups. Intervention group will be treated by varices socks plus Pentoxifylline and controls by varices socks alone. The amount and duration of pain, edema and healing time in both groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012085344N1
Registration date:2011-03-09, 1389/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-09, 1389/12/18
Registrant information
Name
Leila Haji Maghsoudi
Name of organization / entity
Shahrood university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6001
Email address
maghsoudi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2011-01-10, 1389/10/20
Expected recruitment end date
2011-07-11, 1390/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline in the treatment of chronic venous ulcers
Public title
Effect of Pentoxifylline in the treatment of chronic venous ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic venous ulcers. Exclusion criteria: patients with chronic arterial insufficiency.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences and Health Services
Street address
Shahid Babai blvrd.
City
Qazvin
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
51
Health conditions studied
1
Description of health condition studied
chronic venous ulcers
ICD-10 code
I83.0
ICD-10 code description
Varicose veins of lower extremities with ulcer
Primary outcomes
1
Description
Edema
Timepoint
one week
Method of measurement
physical examination
2
Description
pain
Timepoint
one week
Method of measurement
Numerical rating scale
3
Description
Duration of wound healing
Timepoint
one week
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: varices stocking alone
Category
N/A
2
Description
Intervention Group: varices stockings and pentoxifylline 400 mg three times daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vascular clinic, Shahid Rajai hospital
Full name of responsible person
Dr Mohammad Bagher Sohrabi
Street address
Padegan Avenue
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of Medical Sciences and Health Services
Full name of responsible person
Dr mohammad bagher sohrabi
Street address
Shahrood-hafte tir square-Shahrood University of Medical Sciences and Health Services
City
Sahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of Medical Sciences and Health Services
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
Shahrood university of medical sciences
Full name of responsible person
Dr Mohammad Bagher Sohrabi
Position
General Practitioner/ Director of Medical Education
Other areas of specialty/work
Street address
Imam Hossein Hospital, Imam st.
City
Shahrood
Postal code
3616911151
Phone
+98 27 3334 1908
Fax
Email
mb.sohrabi@shmu.ac.ir
Web page address
www.shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood university of medical sciences
Full name of responsible person
Dr Leila Haji Maghsoudi
Position
General surgeon
Other areas of specialty/work
Street address
No. 51, Rudaki Avenue, Imam st.
City
Shahrood
Postal code
3616638586
Phone
+98 27 3222 4530
Fax
Email
l.hajimaghsoudi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrood university of medical sciences
Full name of responsible person
Dr Mohammad Bagher Sohrabi
Position
General Practitioner/ Director of Medical Education
Other areas of specialty/work
Street address
Imam Hossein Hospital, Imam st.
City
Shahrood
Postal code
3616911151
Phone
+98 27 3334 1908
Fax
Email
mb.sohrabi@yahoo.com
Web page address
www.shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)