| 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
|
|
|
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
|
|
|
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.
|