| CTRI Number |
CTRI/2024/11/077480 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Foot pressure analysis in healed diabetic foot ulcer |
|
Scientific Title of Study
|
An observational study of Foot pressure analysis in healed diabetic foot ulcer |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrApurbalal Sarkar |
| Designation |
Postgraduate trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Dept of PMR, IPGMER and KKKM Hosiptal, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
7595926656 |
| Fax |
|
| Email |
drapurbalalsarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasundhara Ghosal |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Dept of PMR, IPGMER and KKKM Hosiptal, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874351897 |
| Fax |
|
| Email |
vasundharaghosal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasundhara Ghosal |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Dept of PMR, IPGMER and KKKM Hosiptal, Bhowanipore, Kolkata
WEST BENGAL
700020
India |
| Phone |
9874351897 |
| Fax |
|
| Email |
vasundharaghosal@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital, Harish Mukherjee Road, Bhowanipore, Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
Dr. Apurbalal Sarkar |
| Address |
Dept of PMR, IPGMER and SSKM Hospital, Harish Mukherjee road, Bhowanipore, Kolkata 700020 |
| Type of Sponsor |
Other [self] |
|
|
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 Apurbalal Sarkar |
IPGMER and SSKM Hospital |
Dept of PMR, IPGMER and SSKM Hosiptal, Bhowanipore, Kolkata
Kolkata
WEST BENGAL |
7595926656
drapurbalalsarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E105||Type 1 diabetes mellitus with circulatory complications, (2) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diabetes Mellitus
Evidence of one healed foot ulcer within 1 month
informed consent |
|
| ExclusionCriteria |
| Details |
local site infection or active ulcer,
fracture or fracture non union, weight more than 400 pounds or less than 60 pounds
severe debilitating illness
poor cognition or psychotic illness
severe osteoporosis or osteomyelitis
uncontrolled diabetis mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure points in foot of patients with healed Diabetic Foot ulcer |
0,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing with Foot Pressure of normal population & need for Shoe modification |
0,3 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
11/12/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Summary:: * Patients with healed diabetic foot ulcers between 40 and 80 years of age will be selected from the OPD of the Department of PM&R at IPGME&R and SSKM Hospital. * Patients will be selected based on inclusion and exclusion criteria. * Patients will be clinically examined after obtaining informed consent. * Patients will be asked to stand on the footplate of a pressure analyzer with bare feet. * Pressure maps will be obtained and analyzed for both feet using computer application. * Patients will be asked to return after 3 months and stand on the footplate of the pressure analyzer with a modified shoe. * Pressure maps will be obtained and analyzed for both feet using computer application. * Comparison will be done between the baseline and post-intervention pressure maps. |