Protocol summary

Study aim
Determining the effect of platelet cryogel on the healing of diabetic foot ulcers
Design
Clinical trial with intervention and control group, double blind, randomized, on 46 patients
Settings and conduct
Context: Clinical Location: Shahrekord Ayatollah Kashani Hospital Methods: 46 diabetic patients with similar diabetic foot ulcers are selected. The number of studied groups is 2 groups of 23, and the control group receives only routine treatment. In addition to the routine treatment, the second group uses 50 grams of platelet cryogel every three days. Double-blind: a list of groups A, B, which represents the intervention and control groups, coding and random selection of subjects without informing the researcher and the patients about the type of treatment received (in both groups) double-blindness of the study to be observed
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Willingness to cooperate with the plan 2. Diabetic patients with fasting blood sugar higher than 126 mg/dL and two-hour blood sugar higher than 200 mg/dL 3. Age 40 to 70 years old with chronic foot ulcer without other accompanying diseases and by gender Exit criteria: 1. The patient's lack of consent to continue cooperation 2. Death of the patient 3. The patient being treated with other chronic wound treatment methods 4. Getting other diseases
Intervention groups
The number of studied groups is 2 groups of 23, and the control group receives only routine treatment. In addition to the routine treatment, the second group uses 50 grams of platelet cryogel every three days.
Main outcome variables
Level of Education Age sex alcohol consumption Duration of diabetes BMI, FBS, Hb A1C, wound area, smoking, blood pressure, insulin use, antidiabetic use, previous wound treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221206056726N1
Registration date: 2023-02-07, 1401/11/18
Registration timing: retrospective

Last update: 2023-02-07, 1401/11/18
Update count: 0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Masoud Fatehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3331 4112
Email address
fatehi67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate The effectiveness of platelet cryogen in improving diabetic foot ulcers compared to routine wound treatment methods.
Public title
Investigate The effectiveness of platelet cryogel in improving diabetic foot ulcers compared to routine wound treatment methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to cooperate with the project Diabetic patients with fasting blood sugar higher than 126 mg/dL and two-hour blood sugar higher than 200 mg/dL Age 40 to 70 years old with chronic foot ulcer without other comorbidities and separated by sex
Exclusion criteria:
The patient's lack of consent to continue cooperation Death of the patient The patient being treated with other chronic wound treatment methods. Getting other diseases
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, diabetic patients with grade 2 or 3 chronic foot ulcers and contaminated type referring to Kashani Shahrekord Hospital were eligible and based on the information contained in the file, after explaining the goals and details of the individual's plan and desire, they were invited to participate in this research. If the answer is positive, first the consent form for participating in the study was obtained. The final stage of selecting people to enter the study was done based on the criteria for entering and not entering the study. Then the eligible people were randomly divided into two groups. Before the start of the study, a list of groups A, B, which represents the intervention and control groups, was coded, and the subjects were randomly selected by themselves without informing the researcher and the patients about the type of treatment received (in both groups) in a double-blind manner. Being a study should be considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, diabetic patients with grade 2 or 3 chronic foot ulcers and contaminated type referring to Kashani Shahrekord Hospital were eligible and based on the information contained in the file, after explaining the goals and details of the individual's plan and desire, they were invited to participate in this research. If the answer is positive, first the consent form for participating in the study was obtained. The final stage of selecting people to enter the study was done based on the criteria for entering and not entering the study. Then the eligible people were randomly divided into two groups. Before the start of the study, a list of groups A, B, which represents the intervention and control groups, was coded, and the subjects were randomly selected by themselves without informing the researcher and the patients about the type of treatment received (in both groups) in a double-blind manner. Being a study should be considered.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of sharekord University of Medical Sciences
Street address
Social Research Center, School of Nursing and Midwifery, University of Medical Sciences, Rahmatiya, Shahr e Kord
City
sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SKUMS.REC.1398.245

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E08.621
ICD-10 code description
Diabetes mellitus due to underlying condition with foot ulcer

Primary outcomes

1

Description
Chronic foot ulcer grade 2 or 3 and contaminated type
Timepoint
1 first day, 2 fifth day, 3 ninth day and 4 fourteenth day
Method of measurement
Sterile ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the routine treatment, the intervention group uses 50 grams of platelet cryogel once every three days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Kashani Hospital
Full name of responsible person
Massoud Fatehi
Street address
School of Nursing and Midwifery, Shahrekord Medical University, Rahmatiya, Shahr e Kord,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1412
Email
MASOUD.FATEHI67@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raisi
Street address
Social Research Center, School of Nursing and Midwifery, University of Medical Sciences, Rahmatiya, Shahr e Kord
City
SHAREKORD
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1412
Email
MASOUD.FATEHI67@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud Fatehi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Social Research Center, School of Nursing and Midwifery, University of Medical Sciences, Rahmatiya, Shahr e Kord
City
SHREKORD
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1412
Email
MASOUD.FATEHI67@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud Fatehi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Social Research Center, School of Nursing and Midwifery, University of Medical Sciences, Rahmatiya, Shahr e Kord
City
sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1412
Email
Masoud.fatehi67@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud fatehi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Social Research Center, School of Nursing and Midwifery, University of Medical Sciences, Rahmatiya, Shahr e Kord
City
sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1412
Email
Masoud.fatehi67@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
2021/03/18
To whom data/document is available
Researchers
Under which criteria data/document could be used
They can use for reference.
From where data/document is obtainable
Masoud Fatehi
What processes are involved for a request to access data/document
Communicating with Mr. Masoud Fatehi through his email to receive information and guidance.
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