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CTRI Number  CTRI/2024/12/077724 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Targeted foot care program ]  
Study Design  Other 
Public Title of Study   Effectiveness of targeted foot care program on foot health practices and foot health status among Diabetic Neuropathy patients  
Scientific Title of Study   Effectiveness of targeted foot care program on foot health practices and foot health status among Diabetic Neuropathy patients attending tertiary hospital, Bhubaneswar 
Trial Acronym  Targeted foot care program 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhumita Kumari 
Designation  MSc Nursing Student 
Affiliation  AIIMS Bhubaneswar 
Address  College of Nursing AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9110953637  
Fax    
Email  madhumitakumari.jnv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anand L 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  College of Nursing AIIMS Bhubaneswar
College of Nursing AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  09612681996  
Fax    
Email  con_anand@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anand L 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  College of Nursing AIIMS Bhubaneswar
College of Nursing AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  09612681996  
Fax    
Email  con_anand@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Non-Funded PG M.Sc Nursing project 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 
Dr Anand L   AIIMS Bhubaneswar   Sijua Patrapada, Bhubaneswar, Odisha, Department-Endocrinology, Division-OPD (Endocrinology/Diabetic OPD, Ground floor)
Khordha
ORISSA 
9612681996

con_anand@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Bhubaneswar  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 
Comparator Agent  Routine care  Diabetic patient came to endocrinology OPD, patient will be screened for clinical diabetic neuropathy using monofilament test. If the patient shows positive monofilament test, meets the inclusion criteria then patient will be recruited as the study sample after consent. After consent the patient will be having pre-test assessment and classification using Inlows 60-second diabetic foot screen tool. After that patient will be asked regarding foot care practices using Nottingham Assessment of Functional Footcare tool. There will not be any intervention. Researcher will assess the same patient foot health status and foot health practices at the time of next follow-up (after 1 month) during post-test using the same previous tools. 
Intervention  Targeted foot care program  •Diabetic patient came to endocrinology OPD, patient will be screened for clinical diabetic neuropathy using monofilament test. •If the patient shows positive monofilament test, meets the inclusion criteria then patient will be recruited as the study sample after consent. •After consent the patient will be having pre-test assessment and classification using Inlows 60-second diabetic foot screen tool. •After classifying into categories, a targeted education cum training session of 15 minutes and 20 minutes respectively will be conducted for the patient and caregiver with the help of pamphlet and PowerPoint, according to the assessed need and categorization. The educational session consists of headings under importance of healthy self-foot care practices, blood glucose level maintenance, appropriate footwear practices, foot skin and nail hygiene, regular checkup and follow up. and the training session will include exercises as Sensory training (wall climbing using feet), Paper ball making, Scribbling from foot, Gait training (normal walk on sraight line). •After the targeted education cum training session the patient will be asked regarding foot care practices using Nottingham Assessment of Functional Footcare tool. •The patient will be advised to adhere to same preventive practices at home. •After that researcher will assess the patient foot health status and foot health practices at the time of next follow-up (after 1 month) during post-test using the same previous tools.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient who are clinically diagnosed with diabetic neuropathy using monofilament test.
Patient who are likely to come for follow-up.
 
 
ExclusionCriteria 
Details  Bilateral lower limb amputation
Pregnancy
Less than 18 years of age
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•To assess the effectiveness of targeted foot care program on foot health practices of diabetic neuropathy patients towards foot health care measures.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Foot health status of diabetic neuropathy patients  3 months 
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
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)   15/12/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

•  This study evaluates the effectiveness of a targeted foot care program on foot health practices and status among diabetic neuropathy patients at AIIMS Bhubaneswar using a quasi-experimental before and after design, participants diagnosed with diabetic neuropathy via monofilament testing will undergo a pre-test assessment, categorizing their risk levels based on Inlow’s 60-second diabetic foot screen. Following this, the intervention includes a 15-minute educational session, and a 20-minute training session focused on exercises designed to enhance foot health. individualized educational and training sessions will be conducted, incorporating key topics such as importance of healthy self-foot care practices, blood glucose level maintenance, appropriate footwear practices, foot skin and nail hygiene, regular checkup and follow up. and the training session will include exercises as sensory training (wall climbing using feet), Paper ball making, Scribbling from foot, Gait training (normal walk on sraight line). After that Patient’s foot care practices will be assessed using Nottingham Assessment of Functional Footcare tool.

•     Participants will be re-evaluated after one month using the Inlow’s 60-second diabetic foot screen and Nottingham Assessment of Functional Footcare questionnaire to assess any improvements in foot health practices and overall foot condition.

•        The study anticipates significant enhancements in foot care practices, ultimately aiming to reduce the risk of foot ulcers among diabetic neuropathy patients. Ethical considerations, including informed consent and confidentiality, will be strictly maintained throughout the research process.

 
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