| CTRI Number |
CTRI/2025/12/098261 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Buerger-Allen leg exercises help people with diabetes improve blood flow in the legs and reduce the risk of foot problems among the Diabetes patients |
|
Scientific Title of Study
|
A study to assess the effectiveness of Buerger- Allen exercise on lower extremity perfusion, peripheral neuropathy symptoms and risk for development of foot ulcer among patients with Diabetes Mellitus at selected hospitals of Mullana, Ambala, Haryana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana |
| Designation |
Student |
| Affiliation |
Maharishi Markendeshwar College of Nursing, Mullana, Ambala |
| Address |
M.M. College of Nursing, Mullana, Ambala
M.M. College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
Kalpanabasati0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpana |
| Designation |
Student |
| Affiliation |
Maharishi Markendeshwar College of Nursing, Mullana, Ambala |
| Address |
M.M. College of Nursing, Mullana, Ambala
M.M. College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
Kalpanabasati0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana |
| Designation |
Student |
| Affiliation |
Maharishi Markendeshwar College of Nursing, Mullana, Ambala |
| Address |
M.M. College of Nursing, Mullana, Ambala
M.M. College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
Kalpanabasati0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, Haryana, Country-India, Pincode- 133203 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Vinay Kumari |
Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
General Inpatient departments
Ambala
HARYANA |
07973596469
vinaykpatial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buerger- Allen exercise |
Intervention- Buerger Allen exercise
Duration- 5 days
Frequency- 2 times a day (Morning, Evening) |
| Comparator Agent |
Routine care |
Routine care (Morning, Evening) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Diabetes Mellitus -Age more than or equal to 18 years, willing to participate in study
, available during the study period
|
|
| ExclusionCriteria |
| Details |
Patients with Diabetes Mellitus-having foot ulcer or foot gangrene, critically ill, having Deep Vein Thrombosis (DVT)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dependent variable: Lower extremity perfusion, Peripheral Neuropathy symptoms and Risk for development of foot ulcer
(Improvement in Lower extremity perfusion, Reduction in Peripheral Neuropathy symptoms and decrease in risk for development of foot ulcer) |
Day 1- Pretest
Day 2- Post test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2025 |
| Date of Study Completion (India) |
07/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
Modification(s)
|
Patient with Diabetes Mellitus is at increased risk of developing peripheral vascular disease, leading to reduced lower extremity perfusion (LEP) and peripheral neuropathy symptoms (PNS). Impaired circulation in lower limbs may further increase risk for development of foot ulcer. Improvement of blood circulation through non- pharmacological management plays a significant role in preventing these complications among individual with Type 2 Diabetes Mellitus. The Buerger- Allen exercise is one such intervention aimed at stimulating and developing collateral circulation thereby enhancing LEP, reducing PNS, minimizing the risk of foot ulcer formation. The study includes two groups: an experimental and a control group. On Day 1 pretest is done, the experimental group receives the Buerger- Allen exercise intervention on Day 1 to Day 6, while control group receives only routine care without the exercise and post-test is conducted on Day 6. The data collection is done using standardised tools in which tool 1 - Foot perfusion parameters are assessed using Ankle brachial index to assess the lower extremity perfusion , tool 2- Michigan Neuropathy screening instrument (MNSI)- to evaluate peripheral neuropathy symptoms and tool 3 - NMAHS ( Modified North Metropolitan Area Health Service East diabetes foot screening and observation tool) - to assess the risk for development of foot ulcer. Dependent variables for the study- lower extremity perfusion, peripheral neuropathy symptoms and risk for development of foot ulcer. Recruitment and data collection have been completed. Data analysis is in progress |