This study was designed to evaluate the efficacy of topical Sildenafil 10% in a double blind randomized placebo controlled trial on pressure sore healing. Hundred patients with grade 1 or 2 bed sore were assigned into two groups (50 each) to receive topical formulation of sildenafil 10% or placebo for 14 days. The grade of bed sore will be evaluated after 7 and 14 days. The results will be compared in these two groups to assess the possible effect of topical sildenafil 10% on bed sore healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105303449N6
Registration date:2011-06-03, 1390/03/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-07-01, 1390/04/10
Expected recruitment end date
2012-07-01, 1391/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of topical formulation of Sildenafil10% in bed sore healing
Public title
Efficacy of topical formulation of Sildenafil10% in bed sore healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Grade 1 or 2 bed sore diagnosed by the pharmacist according to The 2-digit Stirling scale Exclusion criteria: pregnancy or lactation, hypersensitivity reaction to topical formulation, elevated ALT and/or AST to more than 3 times the upper limit of normal with clinical manifestations of liver failure or more than 5 times the upper limit of normal without clinical manifestations of liver failure, unwillingness for entering in the study or discontinuation of follow up
Age
To 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Pharmaceutical Science Research Center
Street address
Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Poursina Avenue
City
Tehran
Postal code
Approval date
2011-01-23, 1389/11/03
Ethics committee reference number
1389/3/3
Health conditions studied
1
Description of health condition studied
Grade 1 or 2 bed sore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer (Pressure ulcer
Primary outcomes
1
Description
Grade of bed sore
Timepoint
7 and 14 days after topical formulation
Method of measurement
evaluationof bed sore grade according to The 2-digit Stirling scale by pharmacist
Secondary outcomes
empty
Intervention groups
1
Description
Control: topical placebo formulation (base of formulation without active ingredient of sildenafil) once daily for 14 days
Category
Treatment - Drugs
2
Description
Intervention: topical sildenafil 10% once daily for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام خمینی
Full name of responsible person
Street address
City
تهران
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Abollahi
Street address
Tehran university of Medical Sciences, Enghelab Ave, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Research Center, Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enghelab Ave,
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)