Critical limb ischemia (CLI) is known for ischemic rest pain, ulcer, or gangrene related to arterial occlusive disease. Main purpose of this study was to assess treatment outcomes with prostavasin for patients with critical limb ischemia that are a poor candidate for surgical intervention. 29 patients with CLI who were poor candidates for surgical treatment and cannot tolerate surgery were enrolled in the study. Patients with CLI who have tolerated the surgery, and vascular anatomy were suitable for reconstruction, were excluded from the study. Prostavasin was administered according to the standard 21 days protocol (40mcg of prostavasin daily in 200 ml of physiological saline solution and infusing the resulting solution i.v. over a period of 2 hours). Patients were followed up regarding rest pain, ulcer healing, gangrene, and need to amputation after 2 weeks, 1 month, and 3 months.
General information
Acronym
epcli
IRCT registration information
IRCT registration number:IRCT201207292220N4
Registration date:2012-08-26, 1391/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-26, 1391/06/05
Registrant information
Name
Mohamad Reza Sobhiyeh
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8001
Email address
mozafar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vascular and trauma research center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Therapeutic Role of Prostavasin in Patients with Critical Limb Ischemia
Public title
Effect of prostavasin in patients with limb ischemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with rest pain;limb ulcer;gangrene related to arterial occlusive disease who can not tolerat surgery ;and vascular anatomy were unsuitable for reconstruction.enrolled in the study.
Exclusion criteria: patients rest pain;limb ulcer;gangrene related to arterial occlusive disease who have tolerated the surgery; and vascular anatomy were suitable for reconstruction, were excluded in the study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
29
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
Shahid Beheshti University of Medical Sciences
Street address
Research Deptuy, Shahid Beheshti University of Medical Sciences,Velenjak
City
Tehran
Postal code
1983969411
Approval date
2011-06-21, 1390/03/31
Ethics committee reference number
54
Health conditions studied
1
Description of health condition studied
critical limb ischemia
ICD-10 code
I70.2
ICD-10 code description
Atherosclerosis of arteries of extremities
Primary outcomes
1
Description
ankle-brachial index
Timepoint
at presentation, 2 weeks, one month, and three months after the administration
Method of measurement
color doppler sonograghy
2
Description
rest pain
Timepoint
2 weeks, one month, and three months after the administration
Method of measurement
history and physical examination
3
Description
healing of ulcer
Timepoint
2 weeks, one month, and three months after the administration
Method of measurement
history and physical examination
4
Description
gangrene
Timepoint
2 weeks, one month, and three months after the administration
Method of measurement
history and physical examination
Secondary outcomes
1
Description
need to amputation
Timepoint
2 weeks, one month, and three months after the administration
Method of measurement
history and physical examination
Intervention groups
1
Description
standard protocol of intravenous administration for 21 days. 40 mcg of prostavasin daily in 200 ml of physiological saline solution and infusing the resulting solution i.v. over a period of 2 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadae Tajrish Hospital
Full name of responsible person
Lotfollah Zadeh Saran
Street address
Shohadae Tajrish Hospital, Tajrish
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr . Rahmati Rodsary Mohammad
Street address
Shahid Beheshti University of Medical Sciences, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Derakhshan Far Amir
Position
vascular surgen
Other areas of specialty/work
Street address
Shohadae Tajrish Hospital, Tajrish
City
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
amirderakhshanfar@gmail.com
Web page address
www.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atqiaee Khashayar
Position
resident of surgery
Other areas of specialty/work
Street address
Shohadae Tajrish Hospital, Tajrish
City
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
khashayaratqiaee@gmail.com
Web page address
www.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sobhiyeh Mohammad Reza
Position
vascular surgen
Other areas of specialty/work
Street address
Shohadae Tajrish Hospital, Tajrish
City
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
mreza_sobhiyeh@yahoo.com
Web page address
www.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)