determination of efficiency of lyophilized human amniotic membrane
determination of duration of wound healing using lyophilized human amniotic membrane
determination of size alteration of the ulcer
determination of improvement of appearance of the ulcer
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Bu ali hosptal, Two arm parallel study, In this study block randomization generated by an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/list ) .
This tool was used to assign patients to the treatment and the control group.
Participants/Inclusion and exclusion criteria
Inclusion: Diabetic patients with chronic wound for which other treatment were effectless.
Exclusion: Patients with infectious wounds due to possible prolifirative effect of amniotic membrane which can worsen the infection.
Intervention groups
Diabetic patients with chronic wound for which other treatment were effectless. patients will be randomly divided into two groups; in intervention group we use hygrogel containing human lyophilized amniotic membrane after cleaning and debridement of the wound. in control group we only clean and debride the wound.
Main outcome variables
ulcer size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042570N1
Registration date:2019-12-28, 1398/10/07
Registration timing:prospective
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
aida rezaei nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 1287
Email address
aidarezaeen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of lyophilized human amniotic membrane as a dressing on chronic diabetic foot wound healing
Public title
Lyophilized human amniotic membrane; a dressing for chronic diabetic foot wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with chronic diabetic foot
HbA1C<8
ulcer duration less than one year
having dorsalis pedis and posterior tibialis pulses
Ulcer size ≥1 cm2 and < 25 cm2
No clinical signs of infection
Exclusion criteria:
other therapies in the last three months
immunocompromised patient
patients with history of allergy or hemostasis disorders
Pregnant or breast feeding
received corticosteroids or immunosuppresive drugs in the last six months
smoking cigarette
Known or suspected malignancy of current ulcer
Age
From 35 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
In this study block randomization generated by an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/list ) .
This tool was used to assign patients to the treatment and the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the products (with and without amniotic membrane) which have the same appearance will be applied by an expert nurse who does not know the group assignment. The wounds will be evaluated by two physicians who do not know the group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran islamic azad university of medical science =
Street address
13th ّFlr., Block A, Central HًQs of the Ministry of Health & Medical Education, Simaye_Iran St., Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.IAU.TMU.REC.1397.145
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
621
ICD-10 code description
E11
Primary outcomes
1
Description
ulcer size
Timepoint
at baseline, in 1 week, 2 weeks, 4 weeks and 6 weeks
Method of measurement
by ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hydro-gel containing lyophilized human amniotic membrane, dress every 2 or 3 days, 3 or 4 times
Category
Treatment - Drugs
2
Description
Control group: sterilized hydro-gel, dress every 2 or 3 days, 3 or 4 times
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu ali Hospital
Full name of responsible person
Zahra Sadeghi
Street address
Buali hospital, Damavand St., Imam Hussein squire
City
Tehran
Province
Tehran
Postal code
1711734353
Phone
+98 21 3334 8035
Email
na@na.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Stem Cell and Regenerative Medicine Research Center
Full name of responsible person
Mohammad Amir Amirkhani
Street address
stem cell and regenerative medicine research center, italia Str. , keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6111 1000
Email
amirkhani@health.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran Medical University
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
The Stem Cell and Regenerative Medicine Research Center
Full name of responsible person
Aida Rezaei Nejad
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
stem cell and regenerative medicine research center, italia Str. , keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
00982161111
Email
aidarezaeen@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The stem cell and regenerative medicine research center
Full name of responsible person
Mohammad Amir Amirkhani
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
stem cell and regenerative medicine research center, italia Str. , keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
00982161111
Email
amirkhani@health.gov.ir
Person responsible for updating data
Contact
Name of organization / entity
The Stem Cell and Regenerative Medicine Research Center
Full name of responsible person
Aida Rezaei Nejad
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
stem cell and regenerative medicine research center, italia Str. , keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
00982161111
Email
aidarezaeen@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
demographic characteristic, clinical and para clinical data before and after study
When the data will become available and for how long
after publishing paper
To whom data/document is available
researchers
Under which criteria data/document could be used
explain about their study
From where data/document is obtainable
corresponding or first author
What processes are involved for a request to access data/document