| 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
|
|
|
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
|
|
|
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. |