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Study of Thyme essential oil effect on infection control of diabetic foot ulcers

Protocol summary

Summary
The objectives of this clinical trial are to evaluate the effect of herbal essential oil of Thyme on infection control of diabetic foot ulcers. Study groups: due the infectious nature of study, outpatients and inpatients of ValiAsr hospital will enter to the study. Sample size: A total of 60 diabetic patients with diabetic foot ulcers will be admitted with obtaining informed consent. In this not blinded study, patients will be randomly divided into two groups of control (n = 30) and intervention (n = 30). Major eligibility criteria of participants: proven diabetes, ulcers on toes, foot, heel, top of toe, having a body mass index of 18 to 35; complete consciousness, age 20 to 80. Exclusion criteria: drug and alcohol abuse, chronic disease effective on diabetic wound healing, any immunosuppressive and cytotoxic drugs user, cancer, amputation case. For both groups, the standard treatment will be performed. For the test group, in addition to standard therapy, diluted essential oil will use. Grid and depth of diabetic foot ulcers in both control and experimental groups before and after the intervention will be assessed by the investigator. Primary outcome time point will be measured before the intervention and every week up to four weeks after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011026394N2
Registration date: 2017-02-10, 1395/11/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Mohammad Arjomandzadegan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
arjomandzadegan@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-02-09, 1395/11/21
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Thyme essential oil effect on infection control of diabetic foot ulcers
Public title
Study of Thyme essential oil effect on infection control of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Proved diabetes; clinical findings indicative for wound infection (redness, swelling and discharge; diabetic foot wound), wounds on toes; foot, the heel and top of the toe; body mass index 18 to 35; full consciousness, age 20 to 80 years. The exclusion criteria: drugs and alcohol abuse; chronic disease other than diabetes affects the healing process of wounds such as severe vascular disease, lupus, rheumatoid arthritis, burgers and kidney failure; Immunosuppressive and cytotoxic drug users.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
randomized grouping to control and intervention groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Pardis of Arak University of Medical Sciences, Basidj Bridge, Sadasht, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
IR.ARAKMU.REC.1395.268

Health conditions studied

1

Description of health condition studied
Diabetic Foot Ulcers
ICD-10 code
E10
ICD-10 code description
diabetes, With peripheral circulatory complications

Primary outcomes

1

Description
Grade of diabetic foot ulcers
Timepoint
Before the intervention and every weeks up to four weeks after the intervention
Method of measurement
Grade and depth of diabetic foot ulcers as centimeters in both control and experimental groups before the intervention, will be assessed by the investigator.

Secondary outcomes

empty

Intervention groups

1

Description
In addition to standard treatment for diabetic foot ulcers as control group, diluted Thyme essential oil will use for wound treatment as spray of Diluted Thyme essential oil with insulin syringe on the wound, gauze embedded with the solution will put on the wound, if needed. This will perform 2 to 4 times per day depending on the patient's condition.
Category
Treatment - Drugs

2

Description
Control group: standard treatment for diabetic foot ulcers will accomplish based on infection control, pressure and if necessary debridement of necrotic tissue. Oral antibiotic therapy appropriate to the condition of patient will admit and wound cleaning with normal saline will perform.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Medicine Faculty, Arak University of Medical Sciences, department of Infectious Diseases
Full name of responsible person
Dr Farshideh Didgar
Street address
Medicine Faculty, Arak University of Medical Sciences, department of Infectious Diseases
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Full name of responsible person
Dr Mohammad Rafiee
Street address
Arak University of Medical Sciences, Vice chancellor for research, Dr Mohammad Rafiee
City
Arak
Grant name
Grant code / Reference number
2691
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Infectious Diseases Research Center
Full name of responsible person
Ghasem Habibi Dehfooli
Position
Research Assistant
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
+98 86 3417 3505
Email
ghasemhabibi.chem@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Infectious Diseases Research Center, Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Position
Associate Professor
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
mmatinam81@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Infectious Diseases Research Center
Full name of responsible person
Ghasem Habibi Dehfooli
Position
Research Assistant
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
ghasemhabibi.chem@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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