Determination the effect of dressings containing autologous conditioned serum as for the treatment of chronic ulcers
Design
Two arm parallel-group concealed, randomized, blinded placebo-controlled phase 3 clinical trial of 30 patients, enrolled between August 2019 and March 2020
Settings and conduct
Thirty diabetic patients with a chronic ulcer at Imam Reza Hospital in Tabriz undergo wound dressing with autologous conditioned serum or normal saline for 5 weeks. Random allocation will be done by random blocking method using 4 and 8 blocks and RASS software and 1: 1 allocation ratio. The two dressings have no different in appearance. Principal investigators, clinical caregivers, outcome assessors and data analysts and reviewers will have no information about study group allocations by the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 1 or 2 Diabetes Mellitus and Wagner grading of lesions 1 or 2 not healing for at least 3 months
Exclusion criteria: Wagner grading of lesions 3 or 4, active infection of the lesion, hemorrhagic disorders and major large vessel disease
Intervention groups
Intervention 1: Dressing containing autologous conditioned serum that is replaced once a week for 5 weeks
Intervention 2: Dressing containing saline normal that is replaced once a week for 5 weeks
Main outcome variables
Ulcer size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100720004422N7
Registration date:2019-08-15, 1398/05/24
Registration timing:prospective
Last update:2019-08-15, 1398/05/24
Update count:1
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3518
Email address
shakourik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of dressings containing autologous conditioned serum as a new method for the treatment of chronic ulcers
Public title
Effect of autologous conditioned serum on the chronic wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 or 2 Diabetes Mellitus
Wagner grading of lesions 1 or 2 not healing for at least 3 months
Exclusion criteria:
Wagner grading of lesions 3 or 4
Active infection of the lesion
Hemorrhagic disorders
Platelet disorders
Major large vessel disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with block sizes of four and eight using RASS software and the allocation ratio of 1:1
Blinding (investigator's opinion)
Triple blinded
Blinding description
Main investigators, caregivers, outcome assessors, data analyser and the participants will not be informed as to whether they are assigned to the study groups until the end of the study. The blinding can be broken at the end of the study if requested by the patients or caregivers, but the blinding can not be broken during the follow-up period.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5789766788
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TBZMED.REC.1398.154
Health conditions studied
1
Description of health condition studied
Chronic diabetic ulcer
ICD-10 code
E14.5
ICD-10 code description
Unspecified diabetes mellitus with peripheral circulatory complications
Primary outcomes
1
Description
Ulcer healing
Timepoint
Wound size measurement at baseline (before intervention) and 7, 14, 21, 28 and 35 days after dressing
Method of measurement
Pressure Ulcer Scale for Healing Includes the extent of the wound, the presence of exudates and the appearance of the wound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dressing containing autologous conditioned serum that is replaced once a week for 5 weeks. To prepare the autologous conditioned serum, fifty milliliters of blood will be drawn from ante-cubital vein of the patients into a blood bag and be transferred to an autoclaved centrifuge tube without anticoagulants. Blood will be incubated aseptically at 37 C° for 24 hours. After incubation the tubes will be centrifuged at 3500 rpm for 10 minutes to retrieve the autologous conditioned serum. A clinical research coordinator will educate the patients about wound care and when to return for dressing replacement.
Category
Treatment - Drugs
2
Description
Control group: Dressing containing saline normal that is replaced once a week for 5 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Seyed Kazem Shakouri
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
skshakouri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jooyban
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5284957362
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tehran
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
skshakouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
skshakouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
skshakouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available