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CTRI Number  CTRI/2025/11/097122 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 09/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Depression and Anxiety among patients with Leg Arterial Disease and finding a relationship with Disease Severity 
Scientific Title of Study   A Cross-Sectional Study of Prevalence of Depression and Anxiety among Patients with Peripheral Arterial Occlusive Disease and its Correlation with Disease Severity 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakshita Singh 
Designation  MBBS Student 
Affiliation  Kasturba Medical College, Manipal 
Address  #1005, NIH-B Block, Kasturba Medical College Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9876396328  
Fax    
Email  rakshita.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pavan Madhukar Bhat 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.bhat@.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Pavan Madhukar Bhat 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Surgery. 3rd floor, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.bhat@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India  
Type of Sponsor  Government funding agency 
 
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 Pavan Bhat  Kasturba Hospital, Manipal  Department of Surgery and Department of Psychiatry, 3rd Floor, Smt. Sharada Madhav Pai OPD Building
Udupi
KARNATAKA 		 9731243720

pavanbhat76@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  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  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients diagnosed with lower limb Peripheral Arterial Occlusive Disease based on Ankle Brachial Index or Doppler Ultrasound Report
 
 
ExclusionCriteria 
Details  Patients with pre-existing severe psychiatric disorders. Patients with cognitive impairments. Patients with concurrent major neurological and musculoskeletal conditions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Detection of Depression and Anxiety with PAOD  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of Severity of PAOD with Anxiety & Depression   at baseline 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   20/11/2025 
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)   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   Peripheral Arterial Occlusive Disease is a commonly occurring lifestyle disease, mostly associated with claudication pain, tissue death and in more severe cases, lower extremity amputation. The disease carries a global burden of more than 230 million people worldwide. Though it is widely prevalent in India, there is a lack of specific guidelines or recommendations for PAD management, which is due to lack of awareness, and also because majority of the focus shifts to treating coronary vascular disease as they have a higher percentage of prevalence. Major etiology involved is arteriosclerosis where build-up of plaque narrows the lumen of the artery. As a compensating mechanism, the artery continues to dilate, by after a point, the lumen becomes very narrow leading to reduced blood flow and subsequent ischemia. Other rare causes also include inflammation, injury, or radiation exposure.  Risk factors commonly seen are diabetes, smoking, hypertension, and hypercholesterolemia. The primary treatment goals include reducing further cardiovascular damage and improving the motility of the limb which is further aided by physiotherapy to enhance the ability of patient to walk. PAOD also remains largely undiagnosed and misdiagnosed, as clinicians consider the constant leg pain to be a part of normal ageing process, or misdiagnose it as arthritis or spinal degrative disease etc. This further can amplify the chances of underdiagnosing depression and anxiety in such patients. Since, the disease is known to have a prolonged treatment, multiple hospital visits, may involve surgical intervention, thereby leading to reduction in productivity, it potentially stirs up various mental health issues like depression and anxiety. Both suspected and diagnosed PAOD patients have substantially higher levels of depression and anxiety symptoms, and often report poor results in Health related quality of life scale. Anxiety and depression is widespread among PAOD patients and often goes undiagnosed by their primary physician. The major obstacle to physical activity among patients with intermittent claudication are pain post daily activity and the presence of other co-morbidities. This study will assess the prevalence of depression and anxiety in POAD patients. Furthermore, severity of POAD using the Fontaine classification will be corelated with depression and anxiety severity scale using PHQ9 and GAD7 respectively. Fontaine staging of POAD is a commonly used scale in clinical research and categorizes patients in total 4 stages. Stage I is Asymptomatic, Stage IIa is pain free, but claudication on more than 200 m, Stage IIb is pain-free but claudication on less than 200m, Stage III is Rest/Nocturnal pain, Stage IV is Necrosis or Gangrene. PHQ9 and GAD7 are WHO approved, easy to use questionnaire based self assessment forms used to assess the prevalence of depression and anxiety respectively. No such study has previously been done in a tertiary setup in coastal Karnataka and will be the first of its kind. The coast is mostly inhabited with fishermen, farmers, rural workers, belonging to lower class, lower and upper middle class, comprising of mostly of people having a direct impact on their wages and livelihood when diagnosed with POAD, thereby making them more prone to developing anxiety and depression.  Patients from lower socioeconomic classes as well as women, are predisposed to have fewer attempts at revascularization, they mostly undergo major amputation and hence are at a higher risk to suffer a major complication postoperatively. These variations in limb preservation outcomes and unequal access to healthcare highlight the urgent need for a holistic umbrella approach to tackle psychosocial and mental health burden of individuals with POAD. This study will not only help address the problem at large, but also spread awareness among people affected and encourage them to seek treatment. 
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