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To study the effect of infrared radiation on the healing of lower extremity ulcers in diabetic foot

Protocol summary

Summary
Background: Diabetic foot ulcer is a worldwide health care concern affecting tens of thousands of patients. If this ulcer is not treated well, it can create irretrievable difficulties. This study was designed to study the effect of infrared radiation on the healing of diabetic foot ulcer. Method: This was a clinical trial that was performed among hospitalized patients in Dr. Ganjavian hospital of Dezful . Sampling was purposeful and 50 patients, with stage 1 or 2 Diabetic foot ulcer, were selected. Then they were divided randomly in two groups. 25 patients were treated by routine dressing and 25 patients by Inferared radiation besides the routine dressing. All subjects matched using age, sex, Body Mass Index (BMI), stage of Diabetic foot ulcer, location of ulcer. Ulcers in two groups, was assessed by checklist in the zero, first, second, third and fourth weeks. Assessment parameters contain: degree of sore, color, periphery tissue of sore and amount of ulcers exudate. State of ulcers was determined and categorized to complete healing, partial healing, without improvement or worsening.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903034011N1
Registration date: 2012-05-17, 1391/02/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-17, 1391/02/28
Registrant information
Name
Ali Sadeghi Moghaddam
Name of organization / entity
Dezful faculty of medical scinces
Country
Iran (Islamic Republic of)
Phone
+98 64 1526 6172
Email address
sadeghi_ali2008@ajmus.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2009-11-06, 1388/08/15
Expected recruitment end date
2010-04-04, 1389/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To study the effect of infrared radiation on the healing of lower extremity ulcers in diabetic foot
Public title
Effect of infrared radiation on the healing of lower extremity ulcers in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- diabetic foot ulcer in extremity organs; 2- diabetic foot ulcer of 1 or 2 degree; 3- having diabetes for at least 5 years. Exclusion criteria: 1- addiction; 2-smoking.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz university of medical sciences
Street address
Central organazation of Ahwaz university of medical sciences, university town
City
Ahwaz
Postal code
15794 - 61357
Approval date
empty
Ethics committee reference number
190//20/8/پ

Health conditions studied

1

Description of health condition studied
Diabetic foot
ICD-10 code
I79.2
ICD-10 code description
Peripheral angiopathy in diseases classified elsewhere

Primary outcomes

1

Description
healing of diabetic foot ulcer
Timepoint
Every week
Method of measurement
Check list to assess diabetic foot healing

Secondary outcomes

1

Description
healing time
Timepoint
during the study
Method of measurement
time from the beginning of study

Intervention groups

1

Description
Infrared radiation to diabetic foot in case group: use of 250-W tungsten lamp, made by OSRAM Company in Germany, after washing up the ulcer in the routine procedure. Before repeating the dressing, the patient was treated by infra-red radiation, once a day and seven days a week. This was carried out in the following way: a thermometer was placed on the surrounding of the healthy skin to record the temperature of that point and to ensure that the temperature did not exceed 42 degrees centigrade. The distance between the infra-red source and the skin was 30 cm and the radiation time was 20 minutes. The radiation angle was chosen as vertical according to Cosinus Lamirt law in order to absorb the maximum radiation and then wet dressing was performed.
Category
Other

2

Description
Routine dressing for control group: patient’s ulcer and its peripheral tissues were immersed in a sterile tub of saline for 20 minutes and then they were dried by sterile gauze and were dressed in a sterile way after being put in a layer of wet gauze. This process was carried out twice a day, seven days a week. In case the dressing was removed because of excessive discharge or wetness, the dressing was repeated.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ganjavian hospital
Full name of responsible person
Street address
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Privait
Full name of responsible person
Ali sadeghi moghaddam
Street address
lDezful faculty of medical Sciences,Dezfu
City
Dezful
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Privait
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Street address
Faculty of Nursing and Midwifery, Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Sciences
Proportion provided by this source
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 faculty of medical scinces
Full name of responsible person
Ali Sadeghi Moghaddam
Position
Master science of nursing, Faculty member
Other areas of specialty/work
Street address
Dezful faculty of medical Sciences, Azadegan
City
Dezful
Postal code
Phone
+98 64 1526 6172
Fax
Email
sadeghi_ali2008@yahoo.com ; sadeghi_ali2008@.ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dezful faculty of medical Sciences
Full name of responsible person
Ali Sadeghi Moghaddam
Position
Master science of nursing
Other areas of specialty/work
Street address
Dezful university of medical Sciences, Azadegan
City
Dezful
Postal code
Phone
+98 64 1526 6172
Fax
Email
sadeghi_ali2008@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Ali Sadeghi Moghaddam
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
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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