This study was designed to evaluate the efficacy of topical sildenafil10% in a double blind randomized placebo controlled trial on grade 1, stage A diabetic foot ulcer (according to University of Texas Foot Wound Classification System). Hundred patients with grade 1, stage A diabetic foot ulcer were assigned into two groups (50 each) to receive topical formulation of sildenafil10% or placebo for 21 days. The grade and depth of ulcer will be evaluated after 7, 14 and 21 days. The results will be compared in these two groups to assess the possible effect of topical sildenafil10% on diabetic foot ulcer healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208123449N10
Registration date:2012-09-07, 1391/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-07, 1391/06/17
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
2013-01-18, 1391/10/29
Expected recruitment end date
2016-02-22, 1394/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of topical formulation of sildenafil 10% in grade and depth of diabetic foot ulcer
Public title
Evaluation of efficacy of topical formulation of sildenafil 10% in diabetic foot ulcer healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetic patients with Grade 1, stage A diabetic foot ulcers according to University of Texas Foot Wound Classification System, wh0 received standard care
Exclusion criteria: patients with grade and stage more than 1, sensitivity reaction to topical formulation, unwillingness for entering in the study or discontinuation of follow up
Age
From 18 years old to 80 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
Tehran University of Medical Sciences
Street address
Ghods Ave, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-08-15, 1391/05/25
Ethics committee reference number
91-02-33-17752
Health conditions studied
1
Description of health condition studied
Diabetic food ulcers
ICD-10 code
L97
ICD-10 code description
Ulcer of lower limb, not elsewhere classified
Primary outcomes
1
Description
grade of diabetic foot ulcer
Timepoint
before intervention and then 7, 14 and 21 days after after intervention
Method of measurement
ulcers will be evaluated according to University of Texas Foot Wound Classification System
Secondary outcomes
1
Description
depth (stage) of diabetic ulcers
Timepoint
before intervention and then 7, 14 and 21 days after after intervention
Method of measurement
ulcers will be evaluated according to University of Texas Foot Wound Classification System
Intervention groups
1
Description
Patients in case (intervention) group will be receive usual treatment of diabetic foot (including topical or systemic antibiotics) in addition to topical sildenafil ointment once daily for 3 weeks.
Category
Treatment - Drugs
2
Description
Patients in control (placebo) group will be receive standard treatment of diabetic foot in addition to placebo (Base of ointment formulation without drug) once daily for 3 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein khalili
Street address
Keshavarz BLV.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs Fatemeh Saeidi
Street address
Ghods Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Hosein Khalili
Position
associated professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 66954715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein khalili
Position
Pharm D
Other areas of specialty/work
Street address
Enghelab Ave.
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)