The purpose of this clinical trial, Effects of Aloe vera cream dressing on healing diabetic foot ulcers. This study is arandomized and double blind. After obtaining informed consent from patients, 34 type 2 diabetic patients with diabetic foot ulcers of grade 1 and 2 in the feet, toes, heels and feet are chosen on the tiller. Wegener classification is performed using the of the degree of injury. Patients are randomly divided into 2 groups. Initially, both groups wound dressing method is routinely washed. Inclusion criteria: age 30-80 years and having HbA1C in the normal range (HbA1C <6.5) is the exit conditions of the study: cancer and cyto toxic drugs,
Immunosuppressive consumption and chronic diseases of diabetes on the healing process is effective for severe wounds such as vascular disease, lupus, rheumatoid arthritis, kidney failure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205289894N1
Registration date:2012-06-11, 1391/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-11, 1391/03/22
Registrant information
Name
Mohammad Maniey
Name of organization / entity
Ahvaz Jondishapor University of Medical Sciences, International branch
Country
Iran (Islamic Republic of)
Phone
+98 64 1526 8774
Email address
mohammadmaniey@yahoo.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2012-02-14, 1390/11/25
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effecacy of Aloe Vera cream dressing on Healing of Diabetic Foot Ulcers: A Double-Blind, RandomizedClinical Trial Study
Public title
Aloe Vera effect on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a diabetic wound grade 1 and 2 based on Wegener's classification; foot ulcers in the extremities (fingers, soles, heels, on foot); having a body mass index 18 to 35; having full consciousness enrollment; age between 30 to 80 years old; patients with controled diabetes by diet and medication and HbA1C in the normal range (HbA1C <6.5). Exclusion criteria: drug and alcohol abuse; smoking; chronic diseases other than diabetes that may affect the healing of wounds such as severe cardiovascular disease, lupus, rheumatoid arthritis, kidney failure; consumption immunosuppressive; cancer and taking cytotoxic drugs.
Age
From 30 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishapor University of Medical Sciences Ethics Committee
Street address
Ahvaz- Golestan street
City
Ahvaz
Postal code
Iran
Approval date
2012-02-12, 1390/11/23
Ethics committee reference number
ETH-446
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E-10
ICD-10 code description
Peripheral angiopathy in diseases classified elsewhere
Primary outcomes
1
Description
Healing of diabetic foot ulcers
Timepoint
weekly
Method of measurement
Evaluation of diabetic foot ulcers based on check list
Secondary outcomes
1
Description
Reduce the size of wound exudate
Timepoint
Weekly
Method of measurement
Check list
Intervention groups
1
Description
In the intervention group, wound and scar tissue around the wound is placed in sterile saline container for 20 minutes. Then will be used of Aloe vera cream 15 percent. So that after washing the wound, a thin layer of cream over the entire surface of the wound is placed Aloe vera and then putting a layer of gas is sterile technique and dressing it twice day, seven days a week will do.
Category
Treatment - Drugs
2
Description
In the control group, wound and scar tissue around the wound placed in sterile saline container for 20 min and then dried with sterile gauze. After washing the wound, a thin layer of placebo over the entire surface of the wound and then put a layer of gas, sterile dressing method and this work will be done twice a day and seven days a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Gangavian Hospital
Full name of responsible person
Mohammad Maniey
Street address
Dezful-Andimeshk road
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ghvaz-Golestan road
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapor 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
Ahvaz Jondishapor Medical Sciences Inter National Unit
Full name of responsible person
Fahimeh Sabeti
Position
Senior experts of Nursing - Director of Nursing Faculty Abadan
Other areas of specialty/work
Street address
Faculty of Nursing Abadan - Housing Units - Shelf 4
City
Abadan
Postal code
Phone
+98 63 1333 3385
Fax
Email
fahimehsabeti@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapor University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
MS in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing Abadan - Housing Units - Shelf 4
City
Abadan
Postal code
Phone
+98 63 1333 3385
Fax
Email
fahimehsabeti@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapor University of Medical Sciences
Full name of responsible person
Mohammad Maniey
Position
Nursing Student
Other areas of specialty/work
Street address
Valiasr avenu- Between Baharan 7-8
City
Dezful
Postal code
64618-95478
Phone
+98 64 1526 8774
Fax
+98 64 1526 8774
Email
mohammadmaniey@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)