Evaluation of TEBADERM Dressing in Comparison with Standard Moist Dressing in Treatment of Chronic Diabetic foot Ulcer
Design
In this study, 60 patients with Wagner Grade 2 diabetic foot ulcer will be recruited in two groups. This study will be a randomized clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be allocated in both intervention group (a chitosan based dressing- TEBADERM) and standard moist dressing for wound care. the patients will been followed weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be wound area changes, complete healing, parenteral antibiotic therapy and hospitalization
Settings and conduct
This study will be conducted at Wound Healing Center of ACECR as a Phase 3 open labeled randomized clinical trial.
Participants/Inclusion and exclusion criteria
Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner I & II full informed consent for recruitment in random allocation
Intervention groups
Intervention group is the using TEBADERM hydrogel dressing and control group is the using standard moist wound dressing.
Main outcome variables
complete healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034485N1
Registration date:2018-01-03, 1396/10/13
Registration timing:registered_while_recruiting
Last update:2018-01-03, 1396/10/13
Update count:0
Registration date
2018-01-03, 1396/10/13
Registrant information
Name
Gholamreza Esmaeeli Djavid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6698 9110
Email address
djavid@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical Laser Research Center, Academic Center for Education, Culture and Research
Tebazist Polymer Company
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of Tebaderm Wound Dressing vs. Moist Wound Dressing in the Treatment of Diabetic Wounds in a Randomized Clinical Trial
Public title
Evaluation of Hydrogel dressing in treatment of Diabetic foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner I & II
full informed consent for recruitment in random allocation
Exclusion criteria:
Suspected osteomyelitis
Evidence of severe Ischemia (ABI less than 0.8)
ESR more than 70
Using corticosteroid or immuno-suppressor drug
Chronic renal failure of Hemodialysis
Charco Joint
Suspected malignancy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of patients will bee done based on block randomization.
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
Motamed Cancer Institute (MCI)
Street address
146, South Gandi Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ACECR.IBCRC.REC.1396.12
Health conditions studied
1
Description of health condition studied
Chronic diabetic foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
complete wound healing during study (at least 6 months)
Timepoint
every month up to Month 6th
Method of measurement
inspection
2
Description
changes of wound area
Timepoint
week 1, 2, 3, 4, 6 month 3, 4, 6
Method of measurement
photography
Secondary outcomes
1
Description
IV Antibiotic therapy
Timepoint
every month up to month 6th
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention group: in this group, the patients will use TEBADERM dressing on their granulated wound daily. the dressing will be changed every 24 hours.
Category
Treatment - Devices
2
Description
Control group: in this group, the patients will use standard dressing which it moisturizes with normal saline every 6 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
ٌWound Healing Center, ACECR of Tehran Unversity of Medical Sciences Branch
Full name of responsible person
Gholamreza Esmaeeli Djavid
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6648 8973
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Seyed Mehdi Tabaie
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6640 4720
Fax
+98 21 6640 4720
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tebazist Polymer
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Tebazist Polymer
Full name of responsible person
Mahmood Ghafghazi
Street address
No. 7, Balavar Alley, Valiaser
City
Tehran
Province
Tehran
Postal code
1445125415
Phone
+98 21 6697 8435
Fax
+98 21 6697 8435
Email
info@treetta.com
Web page address
http://treetta.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tebazist Polymer
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeeli Djavid
Position
MD-PhD/ Director
Latest degree
Ph.D.
Other areas of specialty/work
Biophysics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6640 4720
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeeli Djavid
Position
PhD-MD
Latest degree
Ph.D.
Other areas of specialty/work
Biophysics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6640 4720
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Zahra Torabi Nasaj
Position
Adiminstration
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6640 4720
Email
hosna_nassaj@yahoo.com
Web page address
http://jdtums.ir/
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
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All NA data will be accessible after publication.
When the data will become available and for how long
Time duration for access to the data will begin after publication for 2 years.
To whom data/document is available
Academic faculty member
Under which criteria data/document could be used
Systematic review and meta-analysis
From where data/document is obtainable
Contact with scientific correspondence of the project
What processes are involved for a request to access data/document