Protocol summary

Summary
Wound healing is a regenerative response after surgery or trauma began a coordinated response with pre-and post-operative care or closely related trauma.e purpose of wound healing, reduction of side effects and complications of the diabetic foot and diabetic foot ulcers are a major cause of morbidity in patients with diabetes is still considered to come.Despite the many advances in diagnosis and treatment of diabetic foot problems, but still has not been resolved.A clinical trial to evaluate the effects of Aloe vera cream in healing diabetic foot ulcers in patients who are admitted to University Hospital. Inclusion criteria: a measure of foot ulceration seen to be necrotic tissue.Patients were divided into two groups: one group received a placebo cream base that constitutes Aloe Vera cream is also an antibiotic and a second antibiotic, prior to the patient's medications are photographed Patients then the creams and dressings twice a day for 21 days and 7 -14 and 21 are also at the foot of the patient is taken Wound dressings so that the wound is irrigated with normal saline and then based on which groups have been Aloe vera cream or placebo received after 21 days will be assessed and images are evaluated with image Analysis Software After calculating the Fisher nonparametric statistics and the results of our wounds and Tiny dependent and independent T-test will be analyzed by SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108063576N2
Registration date: 2013-07-16, 1392/04/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Zahra Soleimani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0030
Email address
soleimani.zahra@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-05-19, 1392/02/29
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation efficacy of Aloe vera cream in improvement of diabetic foot
Public title
Evaluation efficacy of Aloe vera cream in improvement of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Patients diagnosed with diabetes and lower extremity wound infections
Age
From 13 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan - Ravandi Arctic Boulevard - Boulevard doctor
City
Kashan
Postal code
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
29/5/1/628/پ

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E-10
ICD-10 code description
Peripheral angiopathy in diseases classified elsewhere

Primary outcomes

1

Description
Healing diabetic foot ulcers
Timepoint
Weekly
Method of measurement
image Analysis

Secondary outcomes

1

Description
Reduction in ulcer size
Timepoint
Weekly
Method of measurement
image Analysis

Intervention groups

1

Description
Patients in the intervention group, the wound is irrigated with normal saline and then become topical aloe vera gel that is placed on the wound dressing, and the band dressing up to be a period of 21 days will be carried out twice a day.
Category
Treatment - Drugs

2

Description
Patients in the control group, the wound is irrigated with normal saline and then put some control on the wound with gauze and bandages are Pansmam twice a day for 21 day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
somaye nadi
Street address
Boulevard doctor , Boulevard qotb ravandi, kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Soleimani
Position
Infectious Disease Specialist
Other areas of specialty/work
Street address
Kashan hospital
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
soleimani.zahra@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Azim Zeraatkar
Position
Nursing student
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
azim_zeraatkar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Azim Zeraatkar
Position
Nursing student
Other areas of specialty/work
Street address
Arctic Blvd Ravandi, Boulevard doctor, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
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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