• reduction of wound size and the proportion of ulcers completely healed after 4 and 6 weeks
• the reduction time of wound size≤50%
• the safety amniotic membrane extract
• not formation of tissues fibrosis and necrosis
Design
clinical trial، controlled
Settings and conduct
All the patients enrolled in the study will be interviewed and the study will be explained for them. If patients agree with study they should read and sign an approved informed consent form prior to enrollment. Basic information related to each patient will be registered .this information contains : General condition of health, age, sex, weight, systemic diseases, duration of diabetic wound, location of ulcer, size of ulcer, degree of destruction and presence or absence of infection.
This study is done at Firoozgar Hospital and the Royan Diabetes Prevention Clinic
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age 18 or older
Ulcer duration of ≥4weeks
No clinical signs of infection ؛
Pregnant or breast feeding; exclusion Criteria
Sensitivity to drug uses
Smoking and drug abuse
Intervention groups
Diabetic foot ulcer Patients
Main outcome variables
• Gender
• Age (years)
• Ulcer location
• Baseline wound size(cm2)
• Time to healing with AME
• Adverse event
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180102038195N1
Registration date:2018-08-16, 1397/05/25
Registration timing:registered_while_recruiting
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Mohammad Azimi alamouty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2233 9913
Email address
m_azimi67@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-25, 1397/05/03
Expected recruitment end date
2018-08-25, 1397/06/03
Actual recruitment start date
2017-07-25, 1396/05/03
Actual recruitment end date
2018-08-25, 1397/06/03
Trial completion date
empty
Scientific title
Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers
Public title
Safety evaluation of amniotic membrane extract in management of the diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 or older
To be able and willing to provide consent letter and agree to comply with study procedures and follow-up evaluations
Ulcer size>1 and <36 cm2
Ulcer duration of ≥4weeks
No clinical signs of infection
Serum creatinine<3・0 mg/dl
Glycosylated haemoglobin (HbA1c)<12%
Adequate circulation
Ankle-brachial index (ABI) between 0・7 and 1・2 or having e a normal Doppler arterial
Exclusion criteria:
participating in another clinical trial
Currently receiving radiation or chemotherapy
known or suspected malignancy of current ulcer
Diagnosis of autoimmune connective tissue disease
Received a biomedical or topical growth factor for their wound within the previous 30 days
Pregnant or breast feeding
Sensitivity to drug uses
Smoking and drug abuse
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Commitee of Royan institute
Street address
Royan Research Institute, East Hafez Alley,Royan St , Bani Hashem Street, Resalat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2017-08-25, 1396/06/03
Ethics committee reference number
1396.63.IR.ACECR.ROYAN.REC
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Side effectes
Timepoint
Every week
Method of measurement
Common Terminology Criteria for Adverse Events
2
Description
Wound healing rate
Timepoint
Every week
Method of measurement
AutoCAD software
Secondary outcomes
empty
Intervention groups
1
Description
Use of amniotic membrane extract in the treatment of diabetic foot ulcers
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mahin Jamshidi
Street address
Firoozgar educational research center, Zahid Valadi Street, Vali Asr Square, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8893 6974
Fax
+98 21 8894 2622
Email
m_azimi67@yahoo.com
Web page address
http://firoozgar.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Marzieh Ebrahimi
Street address
Royan Research Institute, East Hafez Alley,Royan St, Bani Hashem Street, Resalat Highway, Tehran
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
Yes - There is 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
• wound size and proportion reduction of ulcers completely healed after 4 and 6 weeks
• the reduction time of wound size≤50%
• the safety of amniotic membrane extract
• no formation of fibrosis and necrosis tissues
• Pain reduction
• The rate of antibiotics taken during treatment
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
Only for researchers who are working in academic and scientific institutions
Under which criteria data/document could be used
In clinical Trail's
From where data/document is obtainable
Marzieh Ebrahimi
Royan Research Institute, East Hafez Alley,Royan St, Bani Hashem Street, Resalat Highway, Tehran
Work Phone:+ 982122402486
mebrahimi@royaninstitute.org
What processes are involved for a request to access data/document