Comparison of the Effect of PRP (Platelet Rich Plasma) Injection Plus Standard Treatment and Just Standard Treatment in Healing of Diabetic Foot Ulcer in Diabetic Patients
Objectives:
Diabetes is a well-known metabolic disorder which can raise the possibility of infection or ulcers' healing delay. Control and protection of diabetic foot ulcers is very important. The aim of this study is to compare the effect of PRP (Platelet Rich Plasma) with standard treatment (cleaning with normal saline) in healing of diabetic foot in diabetic patients.
Design:
In this trial, 50 diabetic (type 1 or 2) patients with diabetic foot ulcers aged 40-70 years old will be randomly entered into one of the treatment groups and their demographic information and ulcers' sizes will be recorded.
Setting and conduct:
The patients in the first group will receive daily ulcer cleaning with normal saline plus weekly intra-ulcer injection of PRP and the patients of the second group will receive just daily cleaning with normal saline. A surgeon will assess the healing rate and the sizes of ulcers at the beginning of the treatment and then weekly.
Major Inclusion and Exclusion criteria:
The presence of at least 4 weeks of diabetic foot ulcer in patients with diabetes type 1 or 2 and being an uncomplicated ulcer.
Intervention:
Daily ulcer cleaning with normal saline plus weekly intra-ulcer PRP injection or just daily ulcer cleaning with normal saline.
Main outcome measures (variables):
The sizes and rate of ulcers' healing will be recorded during the treatment and finally the result of the groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021519037N5
Registration date:2015-02-24, 1393/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-24, 1393/12/05
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of PRP (Platelet Rich Plasma) Injection Plus Standard Treatment and Just Standard Treatment in Healing of Diabetic Foot Ulcer in Diabetic Patients
Public title
Assessing the Effect of PRP (Platelet Rich Plasma) Injection in Healing of Diabetic Foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic foot ulcer in patients with diabetes type 1 or 2 for at least 4 weeks.
Exclusion criteria:
Infected ulcers, ulcers with Charcot deformities, ulcers with bone involvement, ulcers with the size less than 0.5 or more than 20 cm, pregnant or nursing patients.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be randomly divided into the treatment groups by usage of colored carts.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid-Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
28.20.8858
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes Mellitus
2
Description of health condition studied
Diabetes Mellitus with Peripheral Circulatory Complications
At the beginning of the treatment, 1, 2, 3 and 4 weeks after the beginning of the treatment
Method of measurement
Assessing by one surgeon and documentation
2
Description
The size of the ulcer
Timepoint
At the beginning of the treatment, 1, 2, 3 and 4 weeks after the beginning of the treatment
Method of measurement
Measuring by ruler and documentation
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (Trial group):
Daily cleaning of the ulcer with 1 litr normal saline as the standard treatment (normal saline solution 9mg/ml from Daroupakhsh drug manufacturing company, Tehran, Iran, registered No. 1228057458) with weekly intra-ulcer injection of PRP (2 ml autologous centrifuged platelet-rich plasma) up to 4 doses
Category
Treatment - Drugs
2
Description
Second intervention group (Controll group):
Just daily cleaning of the ulcer with 1 litr normal saline as the standard treatment (normal saline solution 9mg/ml from Daroupakhsh drug manufacturing company, Tehran, Iran, registered No. 1228057458)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat General Hospital
Full name of responsible person
Dr. Heidar Afshar
Street address
Taavon Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Heidar Afshar
Street address
Velayat General Hospital, Taavon Square
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Parsa
Position
Vascular Surgeon, Professor
Other areas of specialty/work
Street address
Velayat General Hospital, Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
hoparsaar2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Velayat Hospital
Full name of responsible person
Dr. Heidar Afshar
Position
General Surgery Resident
Other areas of specialty/work
Street address
Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
yusefi.mahdieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)