The effect of self-care behavior promotion on wound healing in infectious Neuropathic diabetic ulcer
Design
Sample size in this study is 104 diabetic patients with Neuropathic infected wound is considered. Multi-stage simple randomized sampling method is considered. They were randomly assigned to control and test groups. The criteria for entering this study is to diagnose diabetes and suffer from infected wound between age from 30 to 60 years old.
Settings and conduct
Sample size is 104 diabetic patients with Neuropathic infected wound referring to Hazrat Rasool Hospital ,Telma and Ozan clinics.They were randomly assigned to control and test groups.ّFirst, the profile and check list of self-care behavior, and IWGDF form of staging of infection are completed then based on the results of the data will be analyzed.The design of the interventions related to early completion of the questionnaire and the analysis of the results. Both groups will receive antimicrobial dressing but the resources like educational books from Endocrinology and Metabolic center of Tehran University of Medical Sciences Tehran are provided for patients without charge for Intervention group. Moreover patient will train in 4 sessions
Participants/Inclusion and exclusion criteria
Participants include 104 patients in both intervention and control groups. The criteria for entry in this study:Patients afflicted with diabetes between 30 to 60 years old, suffering Neuropathic infected wound.The exclusion criteria of this study are in contrast to the entry criteria.
Intervention groups
The intervention group:beside receiving anti-microbial dressing, will receive a self-care education book on diabetes and received 4 training sessions.The control group: only receive antimicrobial silver dressing.
Main outcome variables
Education and self-care will have better therapeutic outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022500N3
Registration date:2018-09-02, 1397/06/11
Registration timing:registered_while_recruiting
Last update:2018-09-02, 1397/06/11
Update count:0
Registration date
2018-09-02, 1397/06/11
Registrant information
Name
Farbod Ebadi Fard Azar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 0120
Email address
ebadi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-09, 1397/04/18
Expected recruitment end date
2018-10-03, 1397/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care behavior promotion on wound healing in infectious Neuropathic diabetic ulcer
Public title
The effect of self-care behavior promotion on wound healing in infectious Neuropathic diabetic ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ABI review (Ankle brachial index)
Physician's approval in terms of Neuropathy situation
Having an infected wound
Exclusion criteria:
Ischemic condition
Not being listed in the age range
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage simple randomized sampling is considered. Samples were selected randomly from the patient list. Then with simple randomized assigned to control and test groups (each group was 50).
Blinding (investigator's opinion)
Single blinded
Blinding description
In the first stage, the profile and check list of self-care behavior, and IWGDF form of staging of infection are completed then based on the results of the data analysis,in first group just antimicrobial dressing will be applied whereas in second group beside applying antimicrobial dressing the training will be designed and they will receive educational books and printed documents from Endocrinology and Metabolic center of Tehran University of Medical Sciences Tehran are provided to patients without charge.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی ایران
Street address
Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-07, 1397/11/18
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511107004
Health conditions studied
1
Description of health condition studied
ِDiabetic Neuropathy infected wound
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self care
Timepoint
Self-care measurements at the beginning of the study and after the completion of the study
Method of measurement
Self care checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 52 Neuropathic diabetic patients with infected wound receiving antimicrobial dressing with training.
Category
Prevention
2
Description
Control group: 52 Neuropathic diabetic patients with infected wound wound that only received antimicrobial dressing.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Dr Omid Moradi Moghadam
Street address
Hazrat Rasoul Akram Medical Education hospital,Corner of Mansoori Street, Satarkhan street.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5001
Email
moradimoghadam.o@iums.ac.ir
Web page address
http://hrmc.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Medical Ozone
Full name of responsible person
محمد پور تقوی شهرستانی
Street address
Fourth Floor, Medical department 200,beside Tehran clinic hospital , Ghaemagham street