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CTRI Number  CTRI/2016/01/006566 [Registered on: 27/01/2016] Trial Registered Retrospectively
Last Modified On: 25/01/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to study the effect of structured foot health program on Type 2 diabetes mellitus 
Scientific Title of Study   Prevalence of Foot and Musculoskeletal Complications and Effect of Structured Foot Health Program on Foot Biomechanics and Quality of Life in 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  Shashi Kumar C G 
Designation  PhD Scholar 
Affiliation  Manipal University 
Address  Department of Physiotherapy School Of Allied Health Sciences Manipal University Manipal

Dakshina Kannada
KARNATAKA
576104
India 
Phone  8095142297  
Fax    
Email  shash.physio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya 
Designation  Professor and Dr TMA PAI Chair 
Affiliation  Manipal University 
Address  Department of Physiotherapy School Of Allied Health Sciences Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Arun Maiya 
Designation  Professor and Dr TMA PAI Chair 
Affiliation  Manipal University 
Address  Department of Physiotherapy School Of Allied Health Sciences Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy School Of Allied Health Sciences Manipal University 
 
Primary Sponsor  
Name  Council of Scientific and Industrial Research 
Address  Council of Scientific and Industrial Research Human Resource Development Group, CSIR Complex, Library Avenue, Pusa, New Delhi - 110 012.  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shashi Kumar C G  Department of Physiotherapy  School Of Allied Health Sciences Manipal University
Udupi
KARNATAKA 		 8095142297

shash.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba hospital, Manipal. Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physician prescribed management  only physician prescribed management is given 
Intervention  Physician prescribed management and Structured foot health program   Structured foot health program consists of supervised aerobic exercises, intrinsic foot muscle strengthening exercises,self foot care education for 10 days followed by home program consists of moderate intensity exercise and self foot care for 40 minutes/day, 5 days/week for 3 months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed Type 2 diabetic patients With duration of 1 year and above
Age between 30 to 65 years
 
 
ExclusionCriteria 
Details  Cerebero Vascular Accident (CVA)
Ischemic heart diseases
Cardiac arrhythmias
Previous history of lower extremity fractures
Arthritic conditions
Congenital and acquired foot deformities  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Foot bio-mechanics - static and dynamic gait parameters.
2)WHOQOL-BREFF 		 70 Subjects in each group
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Plantar skin thickness, fascia thickness and intrinsic muscle thickness using musculoskeletal Ultrasound  70 subjects in each group 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 2 
Date of First Enrollment (India)   01/04/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a Randomized, participant blinded,parallel group trial comparing the effect of structured foot health program on foot biomechanics and Quality of Life in Type 2 Diabetes Mellitus. This study consists control group and study group with 70 subjects in each group where control group will recieve physician prescribed management and study group will recieve physician prescribed management and structured foot health program .The outcome measures will be Foot Biomechanics using static and dynamic plantar pressure analysis, quality of life using WHOQOL-BREFF questionnaire, plantar intrinsic foot muscle thickness and plantar tissue thickness using musculoskeletal ultrasound. 
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