| CTRI Number |
CTRI/2026/01/100904 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Buerger allen exercise on lower leg tissue perfusion among type 2 diabetes patients in selected area of madurai |
|
Scientific Title of Study
|
Impact of Buerger allen exercise on Lower extremity tissue perfusion among type2 diabetes mellitus patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SALU K DIVAKARAN |
| Designation |
Msc Nursing Student |
| Affiliation |
College of nursing |
| Address |
Department of community health nursing
College of nursing
Madurai medical College
Madurai
Madurai medical college
Madurai
TAMIL NADU
625020
India |
| Phone |
07592918643 |
| Fax |
|
| Email |
salusays@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N RAJALAKSHMI |
| Designation |
NURSING TUTOR GR II |
| Affiliation |
College of nursing |
| Address |
Department community health nursing
College of nursing
Madurai medical College
Madurai
Madurai medical college
Madurai
TAMIL NADU
625020
India |
| Phone |
09789894079 |
| Fax |
|
| Email |
rajkodeemde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr SUDALAI ARAVIND MBBS |
| Designation |
MEDICAL OFFICER |
| Affiliation |
College of nursing |
| Address |
URBAN PRIMARY HEALTH CENTRE
SELLUR
MADURAI
Madurai medical college
Madurai
TAMIL NADU
625020
India |
| Phone |
09092868197 |
| Fax |
|
| Email |
uphcsellur.nic.in |
|
|
Source of Monetary or Material Support
|
| URBAN PRIMARY HEALTH CENTRE
SELLUR
MADURAI |
|
|
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 SUDALAI ARAVIND |
UPHC SELLUR |
DEPARTMENT OF NIN COMMUNICABLE DISEASE
URBAN PRIMARY HEALTH CENTRE
MADURAI
Madurai
TAMIL NADU |
9789894079
conmmcmdu@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
satisfactory condition only |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
buerger allen exercise |
to improve tissue perfusion |
| Comparator Agent |
Buerger allen exercise improve tissue perfusion |
type of exercise to improve tissue perfusion among type 2 diabetes mellitus patients |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ankle brachial index less than 1
diabetes mellitus patients |
|
| ExclusionCriteria |
| Details |
severe osteoarthritis
uncontrolled hypertension
not willing to participate |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effective use of Buerger allen exercises |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of diabetic ulcer |
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/02/2026 |
| 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="1"
Days="15" |
|
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
|
Buerger allen exercise is a specialized exercise intended to improve the perfusion of the lower extremity among diabetes patients. it includes elevation , dangling and resting. it is administered 3 times in a day in a interval of 6 hrs. lower extremity perfusion is checked by ankle brachial index before and after the procedure in order to check the perfusion of lower leg among diabetes patients. ankle brachial index is is the ratio between the highest ankle pressure and highest brachial arm pressure. |