This is a phase II clinical trial in which thirty patients known to have diabetic foot ulcer seeking medical attention in pre-specified centers in Syria will be enrolled in the study. All the patients will be evaluated in terms of meeting a set of inclusion/exclusion criteria (Presence of diabetic foot ulcer for a minimum duration of 1 months, Wound size more than 2 cm squared, etc) and sign a written informed consent prior to recruitment. Patients will receive an oral-topical combination of ANGIPARS twice a day for 8 weeks plus standard wound care. The patients in control group will recieve only standard wound care. Primary outcome measure of this study would be wound size measured in mm2 by multiplying the longest and the shortest wound diameters in mm. Complete wound closure, Ankle Brachial Pressure Index, patient’s quality of life, patient and physician’s global impression will also be assessed as secondary outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102204272N2
Registration date:2011-02-20, 1389/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-20, 1389/12/01
Registrant information
Name
Dr Faten Al akkad
Name of organization / entity
Ministry of Health, Syria
Country
Syrian Arab Republic
Phone
00963112758133
Email address
dqc.dir@moh.gov.sy
Recruitment status
Recruitment complete
Funding source
Pars Roos Biotechnology Co.
Expected recruitment start date
2010-11-01, 1389/08/10
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase II controlled clinical trial to evaluate safety and efficacy of Angipars in patients with diabetic foot ulcer in Syria
Public title
Phase II clinical trial of Angipars in patients with diabetic foot ulcer in Syria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years; Presence of diabetic foot ulcer for a minimum duration of 1 months due to various reasons such as peripheral neuropathy, foot deformity, trauma or inappropriate shoes' limitation of activity, uncontrolled blood glucose, long term diabetes mellitus, etc.;
Wound size more than 2 cm squared;
Age more than 18 and less than 75;
Exclusion criteria:
Presence of acute infection of the ulcer with or without pus drainage or erythema of the ulcer margins of 3 cm width; Presence of wound with visible bone or signs suggestive of acute osteomyelitis; Presence of severe cardiac condition with functional class of 3 or higher or under treatment; Presence of signs and symptoms suggestive of severe and chronic ischemia with absence of peripheral pulses (absence of peripheral pulse alone is not an exclusion criteria); Any concurrent diseases or conditions which delay wound healing (cancer, vasculitis, ect.); Drug and alcohol abuse; Presence of chronic renal failure on hemodialysis or peritoneal dialysis; Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy; Any known drug hypersensitivity; Inability or refusal to sign the informed consent; Receiving any investigational drug within 30 days prior to screening; Pregnancy or intention of becoming pregnant during the study period.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Syria Ministry of Health Ethics committee
Street address
Ministry of Health, Damascus, Syria
City
Damascus
Postal code
Approval date
2010-05-20, 1389/02/30
Ethics committee reference number
6504
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
I79.2
ICD-10 code description
Peripheral angiopathy in diseases classified elsewhere. Diabetic peripheral angiopathy
Primary outcomes
1
Description
Wound size
Timepoint
Begining, Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
Measurment
Secondary outcomes
1
Description
Wound closure
Timepoint
Begining, Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
examination
2
Description
Ankle-Brachial Pressure Index
Timepoint
Begining, Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
Examination
3
Description
Quality of life
Timepoint
Begining, Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
Filling the questionaire
4
Description
Patient Global Impression of Change
Timepoint
Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
Interview
5
Description
Physician Global Impression of Change
Timepoint
Weeks 2, 6, 8, 12 ,16 and 20
Method of measurement
Physicians evaluation
Intervention groups
1
Description
Intervention group: In addition to standard daily wound care, each patient will receive ANGIPARSTM one capsule, 120mg bid for 8 weeks and topical cream bid. The cream should be rubbed around the wound and a thin layer on the surface of the wound.
Category
Treatment - Drugs
2
Description
Control group: In control group patients will recieve only standard wound care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Mujtahid hospital
Full name of responsible person
Dr. Faten Alakkad
Street address
Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pars Roos Biotechnology Co.
Full name of responsible person
Dr. Koorosh Kamali
Street address
No 568, 13 th Alley, Hormozan St., Shahrak-e- gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pars Roos Biotechnology Co.
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
Clinical trial Department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of Department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical trial department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical trial Department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of Department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)