| CTRI Number |
CTRI/2017/09/009899 [Registered on: 25/09/2017] Trial Registered Prospectively |
| Last Modified On: |
23/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pressure exerted on the sole of the foot between individuals with and without blood sugar |
|
Scientific Title of Study
|
Comparison of plantar pressure points between individuals with and without Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sophia Anne Francis |
| Designation |
Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7624846456 |
| Fax |
|
| Email |
sophia_anne5@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Manikandan |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Selvam Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9686738297 |
| Fax |
|
| Email |
selvam.ram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Principle Investigator will be self financing the project. |
|
|
Primary Sponsor
|
| Name |
Sophia Anne Francis |
| Address |
Not applicable as it is self financed by the Principle Investigator. |
| Type of Sponsor |
Other [Self-Financed] |
|
|
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 |
| Sophia Anne Francis |
Diabetic Foot Clinic |
Diabetic Foot Clinic, Department of Physiotherapy, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7624846456
sophia_anne5@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
without Diabetes Mellitus |
| Patients |
with Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Plantar pressure points will be assessed in individual with and without diabetes |
| Intervention |
Not applicable |
Plantar pressure points will be assessed in individual with and without diabetes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Diabetes:
-Diagnosed to have Type 2 Diabetes Mellitus for the past six months
Individuals without Diabetes:
-Non- diabetic as reported by the individuals
-Blood sugar level report indicating non- diabetic
-Age, gender, BMI and foot type matched with T2DM
|
|
| ExclusionCriteria |
| Details |
Individuals with Diabetes:
-Foot deformities
-Any neurological, orthopedic or cardiopulmonary conditions which prevent the individuals from standing
-Lower limb surgeries underwent in less than 6 months
Individuals without Diabetes:
-Pes planus or Pescavus or any other foot deformities
-Any conditions which prevent the individuals from standing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of pressure in different areas of foot in kilo pascals. |
One time point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount of pressure in different areas of foot in kilo pascals. |
one time point. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Potential participants will be screened based on the inclusion and exclusion criteria. The selected participants will be explained about the study and a written informed consent will be obtained for their participation. Demographic details of the participants will be obtained which include, age, height, weight, BMI and foot type. Participants with T2DM will be asked to stand on the platform and the instructions will be given to look at a fixed point on the wall marked at eye level at a distance of two meters. Platform is switched on and the pressures on the different foot pressure points will be recorded. After recording, participants will be asked to step down the platform and relax. The same procedure will be repeated in individuals without diabetes who are age, gender, BMI and foot type matched. The amount of pressure recorded from different areas of foot in individuals with and without T2DM will be subjected to data analysis. Amount of pressure in different areas of foot in kilo pascals will be recorded. SPSS version 16 will be used for data analysis. Descriptive statistics will be used to summarize the demographic variables and quantify the pressure in different areas of foot. Independent t test will be used to compare the pressure in different areas of foot in individuals with and without T2DM. Level of significance will be set at p < 0.05 for the analysis. |