Comparison of clinical outcome and amputation rate in non-infective diabetic wounds treated with platelet-rich plasma and conventional methods
Design
Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The implementation of the randomization process will be done through the design of random blocks.
PRP injection is performed twice a week for three weeks and questionnaires for both groups will be filled after wound healing or deciding to amputate or transform treatment plan.
Participants/Inclusion and exclusion criteria
Inclusion criteria are diabetic patients with grade 1 and 2 lower extremity ulcers and exclusion criteria are patients' unwillingness to continue treatment.
Intervention groups
Taking 20 cc of blood twice a week and injecting PRP twice a week and routine foot dressing
Main outcome variables
Duration of recovery; Amputation rate; Amputation level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160803029181N8
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of platelet-rich plasma in non-infectious diabetic wound healing
Public title
Evaluation of the efficacy of platelet-rich plasma in non-infectious diabetic wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with grade 1 and 2 lower extremity ulcers
Exclusion criteria:
The patient's unwillingness to continue treatment
Increased wound grade
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The form of dressing was the same in both groups, and the clinical care and data analysts did not know what dressing was used.
Placebo
Not used
Assignment
Parallel
Other design features
Production of autologous enriched platelet plasma
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commity of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Danshju blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.547
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Healing time
Timepoint
At the beginning of the study and when 90% recovery is achieved
Method of measurement
Wound size with meter
Secondary outcomes
1
Description
Amputation
Timepoint
At baseline, 4 weeks later, and 8 weeks later
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: Dressing with platelet-rich 2C plasma every 3 days until 90% wound healing
Category
Treatment - Other
2
Description
Control group: Normal dressing with silversulfadiazine daily up to 90% wound healing
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital; Kaj Sq; Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Danshju Ave Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD