1. Comparison Healing, Discharge, Color, Degree and Tissues Around Diabetic Foot Ulcers in Four Amniotic Fluid Bagel Treatment Groups in Doses of 20, 40 and 60% Before and After 8 Weeks of IIntervention
Design
Clinical Trial with Control Group, with Parallel Groups, Three-Way Blind, Randomized, Phase 2 on 92 Patients. Block Method was Used for Randomization
Settings and conduct
Location: Ahvaz Golestan Hospital Diabetes Clinic and Ahvaz Neurogenic Laboratory
Three-Blind Study: Researcher, Research Units and Wound Healing Evaluator (Physician) are not Aware of the Dressing dose.
Method: Random Allocation of Individuals in Intervention and Control Groups; Examination and Washing of the Wound; Placing Three Dressings with Different Doses of Amniotic Fluid on the Wound Site in the Intervention Groups; Placebo Dressing (Containing all Gels Eexcept Amniotic Fluid) in the Control Group
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The Wound must be in the Foot Area, One Year has Passed Since the Wound was Created
Exclusion Criteria: Participant's Refusal to Continue Treatment
Intervention groups
Intervention Group 1: Use of Gel with Amniotic Fluid Formulation with 20%
Intervention Group 2: Use of Gel with Amniotic Fluid Formulation with 40%
Intervention Group 3: Use of Gel with Amniotic Fluid Formulation with 60%
Control Group: Using a Placebo that Contains All of the Gel Except the Amniotic Fluid
Main outcome variables
An Effective Step Towards Healing Diabetic Foot Ulcers; Improve the Quality of Care Provided
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201010048985N1
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Fatemeh Niami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 6626 8868
Email address
fatiniami66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-18, 1399/07/27
Expected recruitment end date
2020-12-17, 1399/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Gel with Middle Aemniotic Formulation in Healing Diabetic Foot Ulcers
Public title
Effect of Gel with Middle Aemniotic Formulation in Diabetic Foot Ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Since the Wound was Made has Passed More than a Year
The Wound Must be in the Foot Area
Exclusion criteria:
The wound is in an area except the foot
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into 4 equal groups by using random block method (8 blocks with equal volume) that will include three intervention groups and a control group. in the random method at first, the blocks are marked with labels A, B, C, D and then each person will be placed in one of the blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For Blinding in this Study, Gel with Ameniotic Fluid Formulation will be Produced by a Pharmacologist in three Doses of 20, 40 and 60pPercent and Placebo and the Dose of Drugs with Lables A, B, C, D that only Pharmacologist is Aware of their Percentage And researchers, participants and data analyzers are not aware of the type of intervention and amniotic fluid concentration.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
No. 8, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6975116955
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.AJUMS.REC.1399.516
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Healing Diabetic Foot Ulcers
Timepoint
From the Beginning of the Study Uuntil 8 Weeks after the Start Date of the Intervention
Method of measurement
Use a Diabetic Foot Wound Healing Checklist
Secondary outcomes
1
Description
Diabetic Foot Wound Healing
Timepoint
From the Beginning of the Study until 8 Weeks after the Start Date of the Intervention
Method of measurement
Diabetic Foot Ulcer Checklist
2
Description
Diabetic Foot Ulcer Discharge
Timepoint
From the Beginning of the Study until 8 Weeks after the Start Date of the Intervention
Method of measurement
Diabetic Foot Ulcer Checklist
3
Description
Diabetic Foot Ulcer Around Tissues
Timepoint
From the Beginning of the Study until 8 Weeks after the Start Date of the Intervention
Method of measurement
Diabetic Foot Ulcer Checklist
4
Description
Diabetic Foot Ulcer Color
Timepoint
From the Beginning of the Study until 8 Weeks after the Start Date of the Intervention
Method of measurement
Diabetic Foot Ulcer Checklist
5
Description
Diabetic Foot Ulcer Degree
Timepoint
From the Beginning of the Study until 8 Weeks after the Start Date of the Intervention
Method of measurement
Diabetic Foot Ulcer Checklist
Intervention groups
1
Description
First Intervention Group: Apply Amniotic Fluid Gel Dressing with a Concentration of 20% every 48 hours for 8 Weeks on Diabetic Foot Ulcers
Category
Treatment - Drugs
2
Description
Second Intervention Group: Apply Amniotic Fluid Gel Dressing with a Concentration of 40% every 48 hours for 8 Weeks on Diabetic Foot Ulcers
Category
Treatment - Drugs
3
Description
Third Intervention Group: Apply Amniotic Fluid Gel Dressing with a Concentration of 60% every 48 hours for 8 Weeks on Diabetic Foot Ulcers
Category
Treatment - Drugs
4
Description
Control Group: Apply Placebo Dressing every 48 hours for 8 Weeks on Diabetic Foot Ulcers
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital Diabetes Clinic
Full name of responsible person
Fatemeh Niami
Street address
No. 8, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 3311 3821
Email
fatiniami66@gmail.com
2
Recruitment center
Name of recruitment center
Neurogenic Laboratory
Full name of responsible person
Fatemeh Niami
Street address
No. 8, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 3311 3821
Email
fatiniami66@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Vice Chancellor for Research and Technology Development of Ahvaz Jundishapur University of Medical Sciences and Health Services - University City -Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 3477
Email
ajums.ac.ir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Niami
Position
Msc Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 6626 8868
Fax
Email
fatiniami66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Molavi Nejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 8 Golestan Blvd, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 1544
Email
shahahrambaraz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Niami
Position
Msc Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Golestan Blvd, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 6626 8868
Fax
Email
fatiniami66@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Some Data such as dDemographic Information and Information about the Mmain Result in this Study can be Shared.
When the data will become available and for how long
Access Period Starts from 2021
To whom data/document is available
The Data will be Available to Researchers Working in Academic and Scientific Institutions
Under which criteria data/document could be used
Information after the Final Publication of the Article can be Accessed by Sending an Email
From where data/document is obtainable
Send Email to the Response Author of the Article
What processes are involved for a request to access data/document