Preparation of ointment containing Echium italicum root extract and evaluation of its effect on diabetic foot ulcer: A randomized controlled clinical trial
Evaluation of the effectiveness of Echium italicum root extract topical ointment on diabetic foot ulcer
Design
Two arm parallel group randomised trial with control group
Settings and conduct
The study will be performed in Al-Zahra hospital of Isfahan. Patients with the inclusion criteria will be randomly assigned to drug (Echium italicum) or control groups. For patients in drug group, Echium italicum root extract topical ointment will be applied for two weeks, while for patients of control group, specific dressing (Aquacel-Ag) will be used for two weeks. Before any intervention, the wound size as the product of the longest length and width as well as the presence or absence of erythema around the wound will be determined and recorded. At the end of 7th and 14th day of intervention, the percent of wound size reduction and the erythema status will be recorded. Furthermore, the number of cases with complete wound healing during the study will be recorded for both groups. Finally, the mentioned variables will be compared between the groups.
Drug Group: Topical ointment of Echium italicum root extract (made by faculty of pharmacy of Isfahan university of medical sciences), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks
Control Group: Specific dressing (Aquacel-Ag), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks
Main outcome variables
Percentage reduction in wound size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N26
Registration date:2023-08-11, 1402/05/20
Registration timing:registered_while_recruiting
Last update:2023-08-11, 1402/05/20
Update count:0
Registration date
2023-08-11, 1402/05/20
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-22, 1402/04/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation of ointment containing Echium italicum root extract and evaluation of its effect on diabetic foot ulcer: A randomized controlled clinical trial
Public title
Effect of Echium italicum root extract in diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 1 or 2 diabetic foot ulcers in one or more areas
Exclusion criteria:
Smoking
Use of Anticoagulant Drugs Within the Last 3 Months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method using blocks of size 4 will be used. So that all possible sequences of two drug and two placebo in each block will be made with each block being numbered. Then, using random number table, the blocks will be selected randomly and the patients will be assigned to the two groups of drug and placebo according to the the blocks sequences.
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
Ethics committee of Zabol University of Medical Sciences
Street address
Vice-chancellery for research, zabol University of Medical Sciences, shahid-Rajaee Avenue, zabol
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.ZBMU.REC.1402.001
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Ulcer reduction percentage
Timepoint
The beginning of the intervention 7 and 14 days after the intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
The number of cases of erythema around the ulcer
Timepoint
The beginning of the intervention 7 and 14 days after the study
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Intervention group, ointment containing Echium italicum root extract (the amount needed to create a layer 3 mm thick on sterile gauze and placed on the wound surface, so as to cover the entire wound surface), once a day with dressing and other routine care including Debridement, rinsing with normal saline and antibiotics will be prescribed for 2 weeks if necessary and blood sugar control. The wound will be washed before applying the gel
Category
Treatment - Drugs
2
Description
Control group: The control group will be given a new dressing (the type of which will be determined based on the type of wound and only one of them will be included in the study) once a day and routine care for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Rasool Soltani
Street address
Al-Zahra hospital, Soffeh Blvrd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Khadijeh Rezaee keikhaee
Street address
zabol University of Medical Sciences, Shahid-Rajaee Avenue
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD