| CTRI Number |
CTRI/2012/01/002381 [Registered on: 27/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Awareness of foot problem and care among diabetic population in India- a questionnaire based survey. |
|
Scientific Title of Study
|
Awareness of foot problem and care among diabetic population in India- a questionnaire based survey. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
himanshu khetarpal |
| Designation |
intern |
| Affiliation |
manipal college of allied health sciences |
| Address |
Dept. of physiotherapy
2nd floor,
manipal college of allied health sciences,
manipal university
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dr.himanshu88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
himanshu khetarpal |
| Designation |
intern |
| Affiliation |
manipal college of allied health sciences |
| Address |
Dept. of physiotherapy
2nd floor,
manipal college of allied health sciences,
manipal university
manipal
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dr.himanshu88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
himanshu khetarpal |
| Designation |
intern |
| Affiliation |
manipal college of allied health sciences |
| Address |
Dept. of physiotherapy
2nd floor,
manipal college of allied health sciences,
manipal university
manipal
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dr.himanshu88@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept. of physiotherapy
manipal college of allied health sciences
manipal university
manipal |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| snehil dixit |
Manipal college of allied health sciences |
dept. of physiotherapy
2nd floor floor
manipal college of allied health sciences
manipal university
Udupi
KARNATAKA |
9986375051
snehildixit83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic population(type 1, type 2, etc.)
Diabetic retinopathy(only if surgical correction is done) |
|
| ExclusionCriteria |
| Details |
1) dementia
2) diabetic retinopathy (without corrected)
3) cognitive impairment
4) uneducated/ illiterate population
5) blindness or any other vision problem which is not corrected. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| awareness level among Indian diabetic population regarding foot care |
DIABETIC FOOT CARE QUESTIONNAIRE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing level of awareness regarding diabetic foot care in indian diabetic population living in urban area and rural area. |
DIABETIC FOOT CARE QUESTIONNAIRE |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prevalence of diabetes is rapidly rising all over the globe and its complications pose a major threat to future public health resources. No data has been reported in Indian population regarding diabetic foot care awareness, hence the study. The objective of the study is to estimate the awareness of foot care in diabetic patients in various parts of India.
Our study hypothesis is that the awareness regarding foot care in diabetic patients is high among educated people and people living in urban areas.
|