This study is double blind. Placebo control and done in razi hospital of Ahwaz.Target of study is effect of pentoxifyllin as an adjunctive drug in antibiotic treatment of diabetic foot infection. The patients with diabetic foot ulcer, grade 2and 3 wagner come to the study and those patients with upper GI upset, Sensitivity of pentoxifylline 3-Sensitivity to methylxanthines and Limb vascular occlusion more than 80 percent were excluded from the study.All of the patients are eighty divided into two groups randomisely. In intervertional group tab Pentoxifylline 400mg are administrated every eight hours for 6 Month. In placebo group ,pelacebo drugs are administrated every eight hours for 6 Month.Then the patients are visited weekly in first month then mounthly for 6 mounth. In each visit we evaluated the patients for:clinical status. ankle/brachial index, decrease of ulcer size and need to ulcer debridmeant,foot amputation,change or discontiniue of antibiotics. Finally, we analyse and compare the placbo and drug groups data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122411872N1
Registration date:2013-02-24, 1391/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-24, 1391/12/06
Registrant information
Name
Hassan Barabadi
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 9539
Email address
barabadi.a@ajums.ir
Recruitment status
Recruitment complete
Funding source
School of Medicine, Jundishapur University of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifyllin and its compration with placebo as an adjunctive drug in diabetic foot ulcer in diabetic patients.
Public title
Effect of pentoxifyllin in diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion critria:Diabetic patients with diabetic foot ulcer grade 2 and 3 wagner exclusion critria:dyspepsia; sensitivity to pentoxifylline; Sensitivity to methylxanthines;limb vascular occlusion more than 80 percent.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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
School of Medicine, Ahwaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Street -
City
Ahwaz
Postal code
61355393
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
eth-608
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
2
Description of health condition studied
Diabetes
ICD-10 code
E14
ICD-10 code description
Unspecified diabetes mellitus
3
Description of health condition studied
diabetes
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
4
Description of health condition studied
diabetes
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus
5
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
non-Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Healing of diabetic foot ulcers
Timepoint
weekly in first month then every month up to six months
Method of measurement
CM and MM
Secondary outcomes
1
Description
ankle/brachial index improvement
Timepoint
weekly in first month then every month up to six months
Method of measurement
with sphingomanometery and with mmHg unit
2
Description
Amputation need
Timepoint
weekly in first month then every month up to six months
Method of measurement
with physical exam , need or dont need
3
Description
debridmeant need
Timepoint
weekly in first month then every month up to six months
Method of measurement
with physical exam, need or dont need
Intervention groups
1
Description
for intervention group; tab Pentoxifylline 400mg every eight hours for 6 Month.
Category
Treatment - Drugs
2
Description
for control group;placebo every eight hours for six month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Razi hospital
Full name of responsible person
Barabadi Hassan Dr
Street address
Razi hospital, West Beach Blvd, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Diabetes Research Center, Ahwaz Jundishapur Medical School
Full name of responsible person
Feghhi Dr
Street address
Diabetes Research Center, Ahwaz Jundishapur Medical School, Golestan street, Ahwaz
City
ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Diabetes Research Center, Ahwaz Jundishapur Medical School
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
Jundishapur University of Medical Sciences
Full name of responsible person
Barabadi Hassan
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Department of Internal medicine, Golestan Hospital, Golestan street, Ahwaz
City
ahwaz
Postal code
61355393
Phone
+98 61 1374 3001
Fax
+98 61 1374 3001
Email
hassan.barabadi@gmail.com
Web page address
http://www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Ehsanpoor
Position
Internist
Other areas of specialty/work
Street address
Razi Hospital, West Coast Blvd
City
Ahwaz
Postal code
61355393
Phone
+98 61 1336 9539
Fax
+98 61 1333 5396
Email
ali990ehs@yahoo.com
Web page address
http://www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapoor Medical Scince Univercity
Full name of responsible person
Barabadi Hassan
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Golestan Hospital
City
Ahwaz
Postal code
61355393
Phone
+98 61 1374 3001
Fax
+98 611335396
Email
barabadi.h@ajumsaac.irhassan.barabadi@gmail.com
Web page address
ttp://www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)