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The use of dressings containing autologous conditioned serum as a new method for the treatment of chronic ulcers

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History
# Registration date Revision Id
2 2021-07-03, 1400/04/12 188923
1 2019-08-15, 1398/05/24 100277
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  • General information

    empty
    18
    empty
    Year
    Yes
    No
    empty
    80
    empty
    Year
    Yes
    No
    Triple blinded
    Single blinded
    1
    1
    empty
    To increase the generalizability of the results and conduct a timely trial
    empty
    جهت افزایش تعمیم پذیری نتایج و انجام به موقع کارآزمایی
    Type 1 or 2 Diabetes Mellitus
    Wagner grading of lesions 1 or 2 not healing for at least 3 months
    Wagner grading of lesions 1 or 2 not healing for at least 3 months
    دیابت نوع 1 یا 2
    گرید 1 یا 2 ضایعه بر اساس سیستم درجه بندی وگنر با عدم ترمیم برای حداقل 3 ماه
    گرید 1 یا 2 ضایعه بر اساس سیستم درجه بندی وگنر با عدم ترمیم برای حداقل 3 ماه
    Permuted block randomization with block sizes of four and eight using RASS software and the allocation ratio of 1:1
    Simple randomization method through computer-generated random numbers by an independent statistician with the allocation ratio of 1:1
    روش بلوک بندی تصادفی با استفاده از بلوک های 4 و 8 تایی و نرم افزار RASS و نسبت تخصیص 1:1
    روش تصادفی ساده از طریق لیست اعداد تصادفی تولید شده توسط کامپیوتر توسط یک متخصص آمار مستقل و نسبت تخصیص 1:1
    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.
    It is not possible to blind the participants to treatment. Furthermore, the treating physicians will not blind to the treatment; however, investigators providing treatment will be different from those performing wound evaluations, and the persons responsible for clinical tests and also the statistician who will execute all the statistical analysis will be blind to study group allocation.
    محققین اصلی، مراقب بالینی، ارزیابی کنندگان پیامد و آنالیز کننده داده ها و بررسی شوندگان اطلاعی در مورد تخصیص گروه های مطالعه تا انتهای مطالعه نخواهند داشت. کورسازی در انتهای مطالعه در صورت درخواست بیماران یا مراقبین ایشان قابل شکستن بوده، ولی در طی دوره مداخله و پیگیری بیماران شکستن آن امکان پذیر نمی باشد.
    کورسازی مشارکت کنندگان به درمان دریافتی ممکن نیست. بعلاوه، پزشکان درمان کننده از نوع درمان آگاه خواهند بود، با اینجال، محققین ارائه دهنده درمان با آنهایی که ارزیابیهای زخم را انجام خواهند داد متفاوتند و افرادمسئول تست های بالینی و متخصصین آمار که انالیزهای آماری را انجام خواهند داد به تخصیص گروه های مطالعه کور خواهند بود.

  • Health conditions studied

    #1
    E14.5
    L99
    Unspecified diabetes mellitus with peripheral circulatory complications
    Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
    Chronic diabetic ulcer
    Chronic ulcer
    زخم مزمن دیابتی
    زخم مزمن

  • Primary outcomes

    #1
    Wound size measurement at baseline (before intervention) and 7, 14, 21, 28 and 35 days after dressing
    Wound size measurement at baseline (before intervention) and 21 days after dressing
    اندازه گیری اندازه زخم در ابتدای مطالعه (قبل از شروع مداخله) و 7، 14، 21، 28 و 35 روز بعد از شروع پانسمان
    اندازه گیری اندازه زخم در ابتدای مطالعه (قبل از شروع مداخله) و21 روز بعد از شروع پانسمان

  • Intervention groups

    #1
    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.
    Intervention group: Dressing containing autologous conditioned serum that is replaced once a week for 3weeks. 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.
    گروه مداخله: پانسمان حاوی سرم اتولوگ فرآوری شده که یک بار در هغته به مدت 5 هفته تعویض می شود. برای تهیه سرم اتولوگ فراوری شده، 50 میلی لیتر خون از ورید بازویی بیماران به کیسه خون منتقل و به یک لوله سانتریفوژ اتوکلاو بدون ماده ضد انعقادی منتقل می شود. خون به مدت 24 ساعت در دمای 37 درجه سانتیگراد انکوبه می شود. پس از انکوباسیون، لوله ها به مدت 10 دقیقه با دور 3500 در دقیقه سانتریفوژ می شوند تا سرم اتولوگ فراوری شده را تولید کنند. فرد هماهنگ کننده پژوهش در مورد مراقبت از زخم و زمان مراجعه مجدد جهت تعویض پانسمان به بیمار آموزش می دهد.
    گروه مداخله: پانسمان حاوی سرم اتولوگ فرآوری شده که یک بار در هغته به مدت 3 هفته تعویض می شود. برای تهیه سرم اتولوگ فراوری شده، 50 میلی لیتر خون از ورید بازویی بیماران به کیسه خون منتقل و به یک لوله سانتریفوژ اتوکلاو بدون ماده ضد انعقادی منتقل می شود. خون به مدت 24 ساعت در دمای 37 درجه سانتیگراد انکوبه می شود. پس از انکوباسیون، لوله ها به مدت 10 دقیقه با دور 3500 در دقیقه سانتریفوژ می شوند تا سرم اتولوگ فراوری شده را تولید کنند. فرد هماهنگ کننده پژوهش در مورد مراقبت از زخم و زمان مراجعه مجدد جهت تعویض پانسمان به بیمار آموزش می دهد.
    #2
    Control group: Dressing containing saline normal that is replaced once a week for 5 weeks
    Control group: Dressing containing saline normal that is replaced once a week for 3 weeks
    گروه کنترل: پانسمان حاوی نرمال سالین که یک بار در هفته به مدت 5 هفته تعویض می شود
    گروه کنترل: پانسمان حاوی نرمال سالین که یک بار در هفته به مدت 3 هفته تعویض می شود

Protocol summary

Study aim
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
To increase the generalizability of the results and conduct a timely trial
Acronym
IRCT registration information
IRCT registration number: IRCT20100720004422N7
Registration date: 2019-08-15, 1398/05/24
Registration timing: prospective

Last update: 2021-07-03, 1400/04/12
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:
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
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method through computer-generated random numbers by an independent statistician with the allocation ratio of 1:1
Blinding (investigator's opinion)
Single blinded
Blinding description
It is not possible to blind the participants to treatment. Furthermore, the treating physicians will not blind to the treatment; however, investigators providing treatment will be different from those performing wound evaluations, and the persons responsible for clinical tests and also the statistician who will execute all the statistical analysis will be blind to study group allocation.
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 ulcer
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Primary outcomes

1

Description
Ulcer healing
Timepoint
Wound size measurement at baseline (before intervention) and 21 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 3weeks. 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 3 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
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