The aim of this study is to survey of affect of aloe Vera anti-ulcer cream after infrared radiation therapy on diabetic foot ulcer. In this randomized clinical trial, a total of 50 participants (enrolled into two groups with Randomize allocated and layout blocks based on gender) were recruited from a tertiary clinic in Dezful (Dr Ganjavian Hospital). The patients aged between 30 and 80 years and were diagnosed with grade I and II foot ulcer based on the Wagner wound classification. Control group received just standard wound care for diabetic foot ulcers and Intervention group received aloe Vera anti-ulcer cream after infrared radiation therapy in addition of standard wound care. The wound surface area is determined as the primary outcome. In this study data will collect by tools included demographic questionnaire and evaluate the chronic wound healing checklist (bets Jensen tool). Patients were followed for 1 month weekly and compared in term of rate of healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504119894N2
Registration date:2016-03-22, 1395/01/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-22, 1395/01/03
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
Vice chancellor for research, Dezful University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of affect of aloe Vera anti-ulcer cream and infrared radiation therapy on diabetic foot ulcer
Public title
The affect of aloe Vera cream and infrared radiation therapy on diabetic foot ulcer
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 smallest than 8).
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 immuno suppressive; 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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dezful University of Medical Sciences
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran Dezful Khozestan
City
Dezful
Postal code
Approval date
2015-08-20, 1394/05/29
Ethics committee reference number
Ir.dums.rec.1394.8
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Ulcer size
Timepoint
Every week, for 4 weeks
Method of measurement
Bets jensen chronic ulcer tools
Secondary outcomes
1
Description
Wound healing
Timepoint
Every week, for 4 weeks
Method of measurement
Bets jensen chronic ulcer tools
Intervention groups
1
Description
Patients in the intervention group, the wound is irrigated with normal saline and then after infrared radiation therapy using topical Aloe Vera gel that is placed on the wound dressing and the band dressing up to be a period of 28 days will be carried out once a day
Category
Rehabilitation
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 dressing once a day for 28 day
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezful Hospital, Dezful University Of Medical Sciences
Full name of responsible person
Hamidreza Aghababaeian
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran Dezful Khozestan
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Dezful University Of Medical Sciences
Full name of responsible person
Feridon Nirozad
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran Dezful Khozestan
City
Dezful
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Dezful 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
Dezful University Of Medical Sciences
Full name of responsible person
Hamidreza Aghababaeian
Position
Faculty member
Other areas of specialty/work
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran Dezful Khozestan
City
Dezful
Postal code
Phone
+98 61 4242 9733
Fax
Email
HAMIDREZAAGHABABAEIAN@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezful University Of Medical Sciences
Full name of responsible person
Hamidreza Aghababaeian
Position
Faculty Member
Other areas of specialty/work
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran Dezful Khozestan Iran, Islamic Republic Of
City
Dezful
Postal code
Phone
+98 61 4242 9733
Fax
Email
HAMIDREZAAGHABABAEIAN@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dezful University Of Medical Sciences
Full name of responsible person
Mohammad Maniey
Position
Faculty Member
Other areas of specialty/work
Street address
Next The Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Postal code
Phone
+98 61 4242 9733
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)