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Effect of Aloe Vera Gel and Lawsoniainermis leaves extracts on the healing process of diabetic foot ulcers.

Protocol summary

Study aim
Determining the effect of aloe vera gel and Lawsoniainermis leaves on the healing process of diabetic foot ulcers
Design
Clinical trial with control and intervention groups, double blind, random sampling available
Settings and conduct
Random sampling is available in patients referred to the 9day hospital who are candidates for diabetic foot ulcers.Neither analyst nor participant will be informed about group allocation. In group A, 20 patients with one centimeter of aloe vera gel in the daily dressing, In group B, 20 individuals with one cc of Lawsoniainermis leaves extract in daily dressing And in the control group, 20 people with one centimeter of hydrogel in daily dressing as placebo, Within 6 weeks, their foot ulcers will be treated locally.After two, four and six weeks of treatment, the extent of the wound and the healing process will be evaluated and recorded by the wound specialist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetes, men and women aged 45-85 years, with multiple or single scars lasting at least four weeks and Second-degree diabetic foot ulcers based on wagner classification. Exclusion criteria:Acute diabetic foot ulcers, Grade 3 and 4 and 5 diabetic foot ulcers, using of drugs that may interfere with wound healing such as Corticosteroid, immunosuppressive and cytotoxic agents and sensitivity to the herbal remedies used in the study.
Intervention groups
In intervention group A, 20 patients with one centimeter of aloe vera gel in the daily dressing, In intervention group B, 20 individuals with one cc of Lawsoniainermis leaves extract in daily dressing And in the control group, 20 people with one centimeter of hydrogel in daily dressing as placebo, Within 6 weeks, their foot ulcers will be treated locally.
Main outcome variables
The effect of aloe vera gel and Lawsoniainermis leaves extract on improving diabetic foot ulcer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160516027925N5
Registration date: 2020-04-25, 1399/02/06
Registration timing: prospective

Last update: 2020-04-25, 1399/02/06
Update count: 0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Amir Zoka
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 4395
Email address
zokaa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aloe Vera Gel and Lawsoniainermis leaves extracts on the healing process of diabetic foot ulcers.
Public title
"The effect of aloe vera and Lawsoniainermis on the healing process of diabetic foot ulcers.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes Men and women in the age range of 45-85 years Patients with multiple or single wounds that have been present for at least four weeks Second-degree diabetic foot ulcers based on wagner classification
Exclusion criteria:
Acute diabetic foot ulcers Grade 3 and 4 and 5 diabetic foot ulcers using of drugs that may interfere with wound healing such as Corticosteroid, immunosuppressive and cytotoxic agents sensitivity to the herbal remedies used in the study
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomized (using Randomization.com site) will be divided into three groups A (intervention), B (intervention) and C (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not know which group they are in. The data analyst and the outcome assessor will also be unaware of which intervention group and which control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Torbate Heydariye University of Medical science
Street address
University of medical science, Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.THUMS.REC.1398.038

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10.7
ICD-10 code description
Insulin-dependent diabetes mellitus with multiple complications

Primary outcomes

1

Description
Healing of diabetic foot ulcers
Timepoint
After two, four and six weeks of treatment
Method of measurement
Evaluation of diabetic foot ulcers based on check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1:Twenty patients with one centimeter of aloe vera gel in their daily dressing, their foot ulcers are treated topically for six weeks.
Category
Treatment - Other

2

Description
Intervention group 2: Twenty people with one cc of Lawsoniainermis leaves extracts in daily dressing, their foot ulcers are treated topically for six weeks.
Category
Treatment - Other

3

Description
Control group: Twenty people with one centimeter of hydrogel in a daily dressing as a placebo, their foot ulcers are treated for six weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
9day hospital Torbat Heydariyeh
Full name of responsible person
Hosein Azizi
Street address
Kashani Street, 9day hospital
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95188-31166
Phone
+98 51 5222 6016
Email
Pr@THUMS.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hasan Azhdari Zarmehri
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6114
Email
azhdarih1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hossein Bakhtiari Dovombaygi
Position
Undergraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Phone
+98 51 5228 6064
Email
Hs.bakhtiari1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hosein Azizi
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Kashani street, 9day hospital
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9518831166
Phone
+98 51 5222 6016
Email
azizitarin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hossein Bakhtiari Dovombaygi
Position
Undergraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
۹۵۱۶۹۱۵۱۶۹
Phone
+98 51 5228 6064
Email
Hs.bakhtiari1998@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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