| CTRI Number |
CTRI/2022/02/040641 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of foot in patients with diabetes mellitus and its effect on balance |
|
Scientific Title of Study
|
Assessment of foot in patients with Chronic Diabetes Mellitus and its effect on balance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiwangi Potnis |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sunandan Diviatia School of science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Super specialty Hospital, SV Road, Vile- Parle West, Mumbai-400056
Mumbai (Suburban)
MAHARASHTRA
380058
India |
| Phone |
08469281138 |
| Fax |
|
| Email |
potnisshiwangi13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shiwangi Potnis |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sunandan Diviatia School of science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Super specialty Hospital, SV Road, Vile- Parle West, Mumbai-400056
Mumbai (Suburban)
MAHARASHTRA
380058
India |
| Phone |
08469281138 |
| Fax |
|
| Email |
potnisshiwangi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiwangi Potnis |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sunandan Diviatia School of science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Super specialty Hospital, SV Road, Vile- Parle West, Mumbai-400056
Mumbai (Suburban)
MAHARASHTRA
380058
India |
| Phone |
08469281138 |
| Fax |
|
| Email |
potnisshiwangi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Sports Medicine, Nanavati Super specialty Hospital |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DR Ali Irani |
Nanavati Superspeciality Hospital |
Department of Physiotherapy, Ground floor, Nanavati Superspeciality Hospital SV Road Vile Parle West 400056
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic Diabetes mellitus (since a year or more than a year). |
|
| ExclusionCriteria |
| Details |
Patients clinically diagnosed with any other peripheral neuropathy.
Patients with history of vertigo, stroke or any other neurological diseases.
Patients with fall risk or balance problems due to any pre-existing musculoskeletal conditions or any particular foot deformities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BERG BALANCE SCALE(BBS)
TIMED UP AND GO TEST(TUG) |
One Time Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
04/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE: ASSESSMENT OF FOOT IN PATIENTS WITH CHRONIC DIABETES MELLITUS AND ITS EFFECT ON BALANCE. INTRODUCTION: Research has shown that Diabetes Mellitus is a chronic metabolic noncommunicable disease. Diabetes affects several organ systems including lower legs and feet with a lot of complications that can be regularly monitored and maybe prevented with a full lower extremity history, physical and treatment plan with patient education. Of this 88 million people, 77 million belong to India. Diabetic foot ulcers were found in 4.54% of patients newly diagnosed with type 2 diabetes mellitus in India; of these, 46.1% had neuropathic, 19.7% had ischemic, and 34.2% had neuro-ischemic foot ulcers. Diabetic foot is one of the most common complications of Diabetes Mellitus. Diabetic foot is defined as the foot of diabetic patient that has potential risk of pathologic consequences including infection, ulceration, and/or destruction of deep tissues associated with neurological abnormalities, various degrees of peripheral vascular diseases and/or metabolic complications of diabetes in lower limb. Diabetic foot assessment includes patient history, neurologic examination, vascular examination, dermatological examination and musculoskeletal examination. Balance is the ability to maintain stability and orientation with the COM over the BOS while parts of the body are in motion. Different scales are used to assess Static and Dynamic Balance. AIM: To assess diabetic foot and its correlation with balance in patients with chronic diabetes mellitus. OBJECTIVES: 1) To assess Diabetic Foot in patients with chronic diabetes mellitus. 2) To assess correlation between diabetic foot and balance in patients with chronic diabetes mellitus. INCLUSION CRITERIA: Patients with Chronic Diabetes mellitus (since a year or more than a year). EXCLUSION CRITERIA: Patients clinically diagnosed with any other peripheral neuropathy. Patients with history of vertigo, stroke or any other neurological diseases. Patients with fall risk or balance problems due to any pre-existing musculoskeletal conditions or any particular foot deformities.
OUTCOME MEASURES: 1) BERG BALANCE SCALE (BBS) 2) TIMED UP AND GO (TUG)
|