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Investigation of the therapeutic potential of fibroblast and adipose-derived mesenchymal stem cells loaded on nanofiber scaffolds for healing the diabetic foot ulcer in diabetic patients and comparison with common procedures.

Protocol summary

Study aim
Since the use of stem cells and diabetes disease are considered as research priorities of the national science foundation, this research tries to heal diabetic foot ulcer effectively by using the stem cells which loaded on nanofiber scaffolds.
Design
The sample size of the study is 20 which will be divided into control and intervention groups by simple randomization.
Settings and conduct
This study will be performed at Endocrine & Metabolism Research Center affiliated to Isfahan University of Medical Sciences. Diabetic patients who are suffering from diabetic foot ulcer will be divided into two completely matched groups. The control group will receive conventional treatment only. The intervention group will receive stem cells bandage in addition to usual treatment. The blinding will not be done in this research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 21 to 65 years old, having diabetic foot wounds that have not recovered despite treatment during the past month, feeling pain while walking and resting, signature written consent. Exclusion criteria: Age over 65 years old, pregnancy or breastfeeding, the presence of septicemia, other systemic diseases in which the kidney is involved, hospitalization due to a serious illness in the past two months, severe malnutrition, the presence of foot ulcer due to all reasons except diabetes and any allergy to the compounds used in the cell culture process.
Intervention groups
Intervention group: Diabetic patients with foot ulcer who received stem cell therapy in addition to routine treatment. Control group: Diabetics patients with foot ulcer who only received routine treatment.
Main outcome variables
Wound size based on cm2; The distance that the patient can walk without pain; Biochemical markers including ALT, AST, Bilirubin, FBS, TG, Cholesterol, BUN, Cr

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190214042712N1
Registration date: 2019-09-17, 1398/06/26
Registration timing: retrospective

Last update: 2019-09-17, 1398/06/26
Update count: 0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Amir Safi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4265 7800
Email address
st-safi.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2018-05-20, 1397/02/30
Trial completion date
2018-08-21, 1397/05/30
Scientific title
Investigation of the therapeutic potential of fibroblast and adipose-derived mesenchymal stem cells loaded on nanofiber scaffolds for healing the diabetic foot ulcer in diabetic patients and comparison with common procedures.
Public title
The use of stem cells loaded on nanofiber tissue scaffolds to repair the diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 21 to 65 years old Having diabetic foot wounds that have not recovered despite a cure during the past month (2-7 cm) Feeling pain at rest and walking Signature written consent
Exclusion criteria:
Patients over 65 years old Pregnancy or breastfeeding The presence of septicemia Other systemic diseases in which the kidney is involved, such as cancer, autoimmune diseases, blood diseases, liver disease and ... Hospitalization due to serious illness in the past two months Severe malnutrition The presence of foot ulcer due to all reasons except for diabetes, for example, syphilis, tuberculosis, or fungal foot Any allergy to the compounds used in the cell culture process
Age
From 21 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.MUI.REC.1395.4.078

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E14.5
ICD-10 code description
Diabetes mellitus with peripheral circulatory complications

Primary outcomes

1

Description
Wound size based on cm2
Timepoint
Before treatment and at every 1 and 2 weeks after treatment
Method of measurement
By multiplying the length of the wound by depth of the wounds

2

Description
The distance that the patient can walk without pain
Timepoint
Before treatment and at every 1 and 2 weeks after treatment
Method of measurement
Meter

3

Description
Biochemical markers including ALT, AST, Bilirubin, FBS, TG, Cholesterol, BUN, Cr
Timepoint
Before and after treatment
Method of measurement
Biochemical tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Diabetic patients with foot ulcer will receive stem cell therapy in addition to routine treatment. The stem cells will be loaded on nanofiber scaffolds in the central lab to prepare and then use the bandages. The treatment sessions will take one to two months, such that in each week one bandage will be put on the foot of patients topically. The patients are regularly visited twice in a week.
Category
Treatment - Other

2

Description
Control group: Diabetics patients with foot ulcer will only receive routine treatments including debridement, Prescribing antibiotics, wound cleaning, and normal dressing.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrine & Metabolism Research Center
Full name of responsible person
Rokhsareh Meamar
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
meamar@pharm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Nosratollah Zargham
Street address
33 NO, 5th alley., North Kargar Street.
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1000
Fax
+98 21 8800 3981
Email
presidency@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
meamar@pharm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
meamar@pharm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
meamar@pharm.mui.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
There is no more information
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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