In this randomized double-blind placebo controlled trial, a total of 300 participants (150 in each of the two arms) will be recruited from a tertiary clinic in Tehran. The patients are aged between 18 and 75 years and are diagnosed with grade II or III foot ulcer based on the Wagner wound classification. The closure of the wound surface area is determined as the primary outcome, whereas the secondary outcome consists of ankle brachial index, toe pressure, wound temperature and the adverse effects of Angipars. These factors will be measured at baseline as well as 2, 4, 6, 10 and 18 weeks after the treatment by an individual unaware of the participants' baseline characteristics and their treatment allocation. We will also collect data and analyze intention-to-treat of our intervention.
The results of this study will provide valuable new information regarding Angipars, a novel herbal drug hypothezised to be effective in treating diabetic foot ulcers (DFU).
General information
Acronym
ADFU
IRCT registration information
IRCT registration number:IRCT138806111414N2
Registration date:2010-03-16, 1388/12/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-03-16, 1388/12/25
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1) Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences, 2) ParsRoos Company
Expected recruitment start date
2010-08-01, 1389/05/10
Expected recruitment end date
2012-08-01, 1391/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Double-Blind Placebo-Controlled Trial of ANGIPARS (TM) in Diabetic Foot Ulcer
Public title
Effects of ANGIPARS in Diabetic Foot Ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
•Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by the American Diabetes Association criteria
•Age equal or more than 18 years and less than 75
•Presence of one or more grade II or III foot ulcers based on the Wagner wound classification more than one square centimiter, for at least 2 weeks. Infection should be treated successfully prior to recruitment
•Haemoglobin A1C less than 10%
•Signing a written informed consent
Exclusion criteria
•Receiving any investigational drug within the last 30 days
•Severe Peripheral Arterial Diseases (PAD), (Ankle Brachial Pressure index less than 0.5)
•Any local or systemic signs of active infection including purulent discharge or marginal skin erythema (up to three centimetres from the margin of the wound)
•Presence of acute osteomyelitis or exposed bone
•Presence of any other systemic or chronic illness such as:
oChronic hepatic diseases
oChronic Kidney Diseases (GFR <60 ml/min per 1.73 m2)
oClinically complicated pulmonary, cardiac, hematologic, gastrointestinal diseases,
oAny other endocrine diseases other than DM
oSerious psychological problems such as severe anxiety or depression
•Malignancy
•Pregnancy or intention to become pregnant during the study period (4.5 months)
•Inability to give an informed consent
•Corticosteroid therapy
•Any drug hypersensitivity
•Radiotherapy, Chemotherapy or the use of any immunosuppressive drugs
•Electrolyte imbalance
•Alcohol or substance misuse
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Endocrinology & Metabolism Research Center
Street address
5th Floor, Doctor Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
1411413137
Approval date
2009-08-15, 1388/05/24
Ethics committee reference number
E-0058
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E10.5
ICD-10 code description
Insulin-dependent diabetes mellitus, With peripheral circulatory complications
2
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.5
ICD-10 code description
Non-insulin-dependent diabetes mellitus, With peripheral circulatory complications
Primary outcomes
1
Description
Wound surface area
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
To determine this outcome, a ruler will be placed at the wound margin and then digital photograph will be taken and the wound surface area will be determined using special software (Hakim Software) through planimetry methods
Secondary outcomes
1
Description
Ankle Brachial Index (ABI)
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
Ratio
2
Description
Toe pressure
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
mmHg(by fastening a small calf around the toe and measuring the capillary pressure by PPGI probe using arterial Doppler sonography)
3
Description
Wound bed temperature
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
Centigrade(by DermaTemp)
4
Description
Patient Global Impression of Change (PGIC)
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
Through a 10-point scale (P&CGIC-Form)
5
Description
Quality of life
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
SF-12 HEALTH SURVER (Iranian Version)
6
Description
Clinical Global Impression of Change (CGIC)
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
Through a 10-point scale(P&CGIC-Form)
7
Description
Clinical assessment of advers event
Timepoint
Baseline, weeks 2, 4, 6, 10, and 18
Method of measurement
Adverse Event Report Form
Intervention groups
1
Description
Angipars 1 capsule, 100 mg bid in addition to 3% topical cream bid for a period of 6 weeks in addition to standard wound care (glycemic control , debridement, dressing, offloading and infection control)
Category
Treatment - Drugs
2
Description
Placebo, the same drug preparations contained inert substances, with the same dosage and administration route as intervention group in addition to standard wound care
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic and Metabolic Center of Tehran affiliated to Endocrinology and Metabolism Research Center
Full name of responsible person
Mashayekh Bakhshi F
Street address
Cross Heyat St., Shahrivar Avenue, North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences
Full name of responsible person
Heshmat R
Street address
5th Floor, Doctor Shariati Hospital, North Kargar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
ParsRoos Company
Full name of responsible person
Madani S.H.
Street address
No. 568,13th alley, Hormozan st., Sahrak-e-Ghods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ParsRoos Company
Proportion provided by this source
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
Endocrinology and Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Larijani B
Position
Endocrinologic Subspecialist
Other areas of specialty/work
Street address
th Floor, Doctor Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411413137
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
http://vcemrc.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Endocrinology and Metabolism Research Center of Tehran University of Medical Sciences(EMRC of TUMS)
Full name of responsible person
Heshmat R
Position
Research Deputy of EMRC / Epidemiologist
Other areas of specialty/work
Street address
5th Floor, Doctor Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411413137
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
rheshmat@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)