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CTRI Number  CTRI/2025/07/092050 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   assessment of Awareness of lifestyle modifications, practices and barriers in Lower Limb Amputees secondary to T2DM in Pune City 
Scientific Title of Study   Assessment of awareness of lifestyle modifications, practices and its barriers in lower limb amputees secondary to T2DM in Pune City A survey 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi L Soman 
Designation  Assistant Professor 
Affiliation  Deccan Education Society’s, Brijlal Jindal College of Physiotherapy, Pune 
Address  Department of Kinesiotherapy, Ground floor, Deccan Education Societys Brijlal Jindal College of Physiotherapy, Pune

Pune
MAHARASHTRA
411005
India 
Phone  919096003300  
Fax    
Email  aditi.soman@despune.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditi L Soman 
Designation  Assistant Professor 
Affiliation  Deccan Education Society’s, Brijlal Jindal College of Physiotherapy, Pune 
Address  Department of Kinesiotherapy, Ground floor, Deccan Education Societys Brijlal Jindal College of Physiotherapy, Pune

Pune
MAHARASHTRA
411005
India 
Phone  919096003300  
Fax    
Email  aditi.soman@despune.org  
 
Details of Contact Person
Public Query
 
Name  Aarya Gune 
Designation  UG student 
Affiliation  Deccan Education Society’s Brijlal Jindal College of Physiotherapy 
Address  ground floor, Department of Kinesiotherapy, Deccan Education Societys Brijlal Jindal College of Physiotherapy

Pune
MAHARASHTRA
411005
India 
Phone  919769138398  
Fax    
Email  aaryagune@gmail.com  
 
Source of Monetary or Material Support  
self funded study study will be conducted at Bharat Vikas Parishad Prosthesis fitting centre, Pune  
 
Primary Sponsor  
Name  nil 
Address  self funded 
Type of Sponsor  Other [self funded] 
 
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 
Jayant Sathe  Bharat Vikas Parishad Vikalang Punarvasan Kendra  Vikalang Punarvasan Kendra, ground floor, PMC Tharkude clinic, Erandawane, Nal Stop, Pune, 411004
Pune
MAHARASHTRA 
91920730453

bvpvikalangkendrapune@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Lower limb amputees who have undergone amputation secondary to T2DM. 2.Amputees between 40 to 60 years of age. 3. Atleast 6 months after amputation surgery.4. Amputees living in Pune City. 5.Amputees with education atleast upto 10th standard. 
 
ExclusionCriteria 
Details  1. Lower limb amputees who underwent surgery due to any other causes. 2.Amputees with cognitive, musculoskeletal or neurological impairments which makes it difficult for them to follow lifestyle modifications 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
self made questionnaire will be ADMINISTERED ONLY ONCE.  ONCE ONLY 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/09/2025 
Date of Study Completion (India) 14/10/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Amputation is surgical removal of a distal part of the body; which could be a finger, toe or part of a limb through different levels depending on the pathology. Lower limb amputations are more common than upper limb amputations. Road traffic accidents, gangrene secondary to diabetes and peripheral arterial diseases, electric burns or soft tissue cancers lead to amputations. 30-80% lower limb amputations are secondary to diabetic complications.

Diabetes causes secondary complications of which impaired wound healing, impaired peripheral circulation and increased risk of infections leads to dry or wet gangrene. To prevent spread of infections amputation surgery is performed in patients suffering from gangrene of lower limbs.

Modifiable factors implicated in development of type 2 diabetes are – fat rich diet, oily food, sedentary lifestyle, addictions of alcohol, tobacco chewing, etc. Foot care is important in diabetics as peripheral sensations can be impaired thus, monitoring feet, detecting wounds and seeking appropriate treatment is important to prevent risk of amputations.

Lifestyle modifications is the first line treatment of type 2 diabetes. Lower limb amputees with type 2 diabetes are at a high risk of revision amputations. Lifestyle modifications reduce the risk of revision amputations due to diabetic complications. It is important to study awareness and practices of lifestyle modifications and barriers due to which amputees may not be able to practice appropriate lifestyle modification.

To assess awareness and practices of lifestyle modifications and its barriers in lower limb amputees secondary to Type 2 Diabetes Mellitus.

A survey using purposive sampling method will be conducted on 128 participants over 6 months in Pune city. A self- designed questionnaire is developed and validated to assess awareness about lifestyle modifications, practices and barriers in lower limb amputees secondary to T2DM. Descriptive statistical analysis will be used to interpret the result.


 
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