Evaluation of Safety and Efficacy of Hydropolymer Dressing (Hydrogel) with Thymol for the Treatment of Neuropatic Diabetic Foot Ulcer in a Phase I/II Clinical Trail
Evaluation of Safety and Efficacy of Hydropolymer Dressing (Hydrogel) with Thymol for the Treatment of Neuropatic Diabetic Foot Ulcer
Design
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be used thymol-honey (Herbaderm) for wound care. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
Settings and conduct
This study will be conducted at Wound Healing Center of Yara Institute, ACECR, as a Phase I and II clinical trial in the volunteers with neuropatic diabetic foot wound.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner II full informed consent for recruitment in the study Suitable tissue perfusion (ABI>0.8) and normal flow of main arteries in lower extremities
Exclusion criteria:
Suspected osteomyelitis Using corticosteroid or immunosuppressor drug Chronic renal failure or hemodialysis
Intervention groups
Thymol-honey gel dressing (Herbaderm) and control group is the using standard moist wound dressing
Main outcome variables
1) Local and systemic side effects 2) complete healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034485N3
Registration date:2018-12-30, 1397/10/09
Registration timing:registered_while_recruiting
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
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
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Safety and Efficacy of Hydropolymer Dressing (Hydrogel) with Thymol for the Treatment of Neuropatic Diabetic Foot Ulcer in a Phase I/II Clinical Trail
Public title
Thymol Dressing in Diabetic foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner I & II
Full informed consent for recruitment in the study
Age between 18-70 years
Exclusion criteria:
Suspected osteomyelitis
Using corticosteroid or immunosuppressor drug
Chronic renal failure and hemodialysis
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Motamed Cancer Institute (MCI)
Street address
ACECR Central Office, No. 1270 Enqelab Avenue
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.ACECR.IBCRC.REC.1397.004
Health conditions studied
1
Description of health condition studied
Chronic neuropathic diabetic foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Local and systemic side-effects
Timepoint
Every month up to month 6th (or complete healing)
Method of measurement
Clinical examination
2
Description
Complete wound healing during study (at least 6 months)
Timepoint
Every month up to month 6th
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, the patients will use thymol-honey (Herbaderm) dressing on their granulated wound daily. the dressing will be changed every 24 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
ٌWound Healing Center, Yara Institute, ACECR
Full name of responsible person
Gholamreza Esmaeeli Djavid
Street address
No. 65 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6698 9110
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
smtabaie@yahoo.com
Web page address
http://jdtums.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Atin Biopolymer Products (Joint Stock)
Full name of responsible person
Alireza Kamangar
Street address
Unit4, No. 8, Corner of the 6th West Alley, Farhang Square, 24 Meter Boulevard, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998695911
Phone
+98 21 2212 9976
Fax
+98 21 2234 5213
Email
ar.kamangar@gmail.com
Web page address
https://atinmed.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Atin Biopolymer Products (Joint Stock)
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
Assistant Professor, MD-PhD
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 6698 9110
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
Assistant Professor
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 6698 9110
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Person responsible for updating data
Contact
Name of organization / entity
Atin Biopolymer Product
Full name of responsible person
Amin Mohammadi Pourfard
Position
پژوهشگر
Latest degree
Ph.D.
Other areas of specialty/work
Biotechnology
Street address
Unit 4, No. 8, Corner of the 6th West Alley, Farhang Square, 34 Meters Boulevard , Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998695911
Phone
+98 21 2212 9976
Fax
+98 21 2212 9976
Email
purfard@yahoo.com
Web page address
https://atinmed.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
Not applicable
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
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