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CTRI Number  CTRI/2026/01/100047 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Study to assess the micro circulation in Patients with Peripheral Artery Disease following Buergers exercise using Laser Speckle Contrast Imaging (Angiocam) 
Scientific Title of Study   Assessment of the immediate effect of Buerger-Allen exercise on the skin perfusion levels using Laser Speckle Contrast Imaging in patients with Peripheral Artery Disease - A quasi experimental study 
Trial Acronym  ANGIOCAM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srihari Sharma K N 
Designation  Associate Professor 
Affiliation  Dayananda Sagar University 
Address  Department of Cardiovascular Physiotherapy and Rehabilitation, No. HS219, College of Physiotherapy 2nd Floor, School of Health Sciences Building Dayananda Sagar University Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.

Bangalore
KARNATAKA
562112
India 
Phone  9886040520  
Fax    
Email  srihari-physio@dsu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Srihari Sharma K N 
Designation  Associate Professor 
Affiliation  Dayananda Sagar University 
Address  Department of Cardiovascular Physiotherapy and Rehabilitation, No. HS219, College of Physiotherapy 2nd Floor, School of Health Sciences Building Dayananda Sagar University Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.


KARNATAKA
562112
India 
Phone  9886040520  
Fax    
Email  srihari-physio@dsu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Srihari Sharma K N 
Designation  Associate Professor 
Affiliation  Dayananda Sagar University 
Address  Department of Cardiovascular Physiotherapy and Rehabilitation, No. HS219, College of Physiotherapy 2nd Floor, School of Health Sciences Building Dayananda Sagar University Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.


KARNATAKA
562112
India 
Phone  9886040520  
Fax    
Email  srihari-physio@dsu.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dayananda Sagar University 
Address  Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt. – 562 112 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Ayati Devices Pvt Ltd  BLOCK A, 2nd Floor, DERBI Foundation, Dayanand Sagar University, Kudlu gate, Bangalore 560068 
Sri Jayadeva Institute of Cardiovascular Sciences and Research  B T M I stage, B-8, Marenahalli Rd, KEB Colony, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srihari Sharma K N  College of Physiotherapy  Department of Cardiovascular Physiotherapy and Rehabilitation, No. HS219, 2nd Floor Health Science Block, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt. – 562 112
Bangalore
KARNATAKA 		 9886040520

srihari-physio@dsu.edu.in 
Dr Muralikrishna  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Vascular Surgery OPD, Ground floor, New Infosys Foundation Block, B T M I stage, B-8, Marenahalli Rd, KEB Colony, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA 		 9880133066

drmurali1978@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
College of Physiotherapy, DSU  Approved 
Sri Jayadeva Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buerger-Allen exercise   First, the patient lies flat on the plinth with legs elevated from 45 degrees until the skin turns pale, it will take approximately 2 minutes to occur and this time varies from one individual to another. Then the patient turns to sit at the edge of the plinth with feet hanging and doing the following exercises; dorsiflexion, plantar flexion, inversion, eversion, and flexion and extension of toes, this phase may also be maintained for 2 minutes. Finally, the patient lies flat with his leg rested in a horizontal position and covered with a warm blanket for about 5 minutes. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed Peripheral Artery Disease (PAD) of the lower limbs based on clinical assessment and objective vascular testing (e.g., ABI, Doppler, CTA/MRA/DSA)
Scheduled for endovascular intervention (angioplasty ± stenting ± adjunctive procedures) for lower-limb PAD
At least one accessible imaging site on the foot, ankle, or distal leg suitable for LSCI imaging (not fully covered by casts, heavy dressings, or external fixation)
Able to lie supine and tolerate LSCI imaging immediately pre- and post-intervention
Able and willing to provide written informed consent
 
 
ExclusionCriteria 
Details  Acute limb ischemia requiring emergency revascularization or thrombectomy where study imaging could delay life- or limb-saving treatment
Hemodynamic instability or critical illness (e.g., on inotropic support, severe sepsis) precluding safe participation
Extensive limb dressings, external fixation, or plaster casts that prevent adequate LSCI imaging of the distal limb
Major tissue loss or active infection at planned imaging sites that could interfere with perfusion measurements
Inability or unwillingness to comply with the imaging protocol or required follow-up assessments
Concurrent participation in another interventional trial that, in the opinion of the investigator, could confound perfusion measurements
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Level of Perfusion using Angiocam - Laser Speckle Contrast Imaging device  Baseline and 3 days  
 
Secondary Outcome  
Outcome  TimePoints 
Distal pulses & Doppler waveform characteristics
 		 baseline & 3 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/01/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Examination of lower extremities for physical abnormalities, ulcers, or skin discoloration will be done.
The participant will undergo basic vascular examination, including pulse palpation (dorsalis pedis, posterior tibial).
Measurement of Ankle-Brachial Index (ABI):will be performed using two different techniques:
Manual ABI measurement (using standard Doppler method by Investigator as well as Vasosense ABI measurement (oscillometric, automate)
Perfusion imaging will be performed using Angiocam (Ayati Devices, India) at predefined anatomical regions of interest (ROIs) on the foot.
Images will be captured and analysed over the dorsal foot, plantar foot, medial foot, and lateral foot regions to quantify perfusion changes.
Buerger-Allen exercise is prescribed to the participant.as per the standard protocol.
Immediate post intervention assessments of the patient’s skin perfusion levels are taken.
 
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