----Protocol of Thesis Submitted for MS General Surgery

Dr Aseshta Sharma
Junior Resident
Department of General Surgery
All India Institute of Medical Sciences Raebareli
Uttar Pradesh, India

1
To Date : 30/12/2023
The Dean (Academic),
All India Institute of Medical Sciences Raebareli
Through proper channel
Respected sir/madam,
I, Dr. Aseshta Sharma, Junior Resident (Academic) in the Department of General Surgery, am
submitting the protocol of my MS thesis entitled “Clinical study of venous ulcer disease and
assessment of co-existing Lower Extremity Arterial Disease (LEAD) using Ankle Brachial
Pressure Index (ABPI)” prepared under the guidance of Dr. Sankalp, duly completed in all
respects, for consideration and approval, to be carried out in the Department of CTVS/ General
surgery at All India Institute of Medical Sciences Raebareli, India.

Thanking you
Yours sincerely
Dr. Aseshta Sharma
Junior Resident (Academic)
Department of General Surgery
AIIMS Raebareli
Email-aseshta.sharma97@gmail.com
Mobile no. 9960765081

Forwarded and recommended-

Dr. Sunita Singh (Associate Professor)
Head of Department (General Surgery), AIIMS Raebareli

2
Application for Approval of Thesis Protocol for MS General Surgery

Name: Dr. Aseshta Sharma

Course to which admitted: MS (General Surgery)
Date of admission: 30/08/2023
Title: “Clinical study of venous ulcer disease and assessment of co-existing Lower Extremity
Arterial Disease (LEAD) using Ankle Brachial Pressure Index (ABPI)”
Names, designations and addresses of guides:
Chief Guide: Dr. Sankalp
ASSISTANT PROFESSOR
CTVS DEPARTMENT
AIIMS RAEBARELI
Email: drsankalp85@gmail.com

Co-Guide Dr. Niraj Kumar Srivastava

ASSOCIATE PROFESSOR
GENERAL SURGERY DEPARTMENT
AIIMS RAEBARELI
Email: nirajsri09@gmail.com

Date: 30th december 2023 Signature of the Candidate

(Aseshta sharma)

3
Certificate and Recommendation of Guides

We certify that the facilities for working on the mentioned subject of the thesis do exist in the
department / hospital / laboratory under our charge and will be provided to the candidate for his
research work. We shall guide the candidate in his work and shall ensure that data being included
in the thesis are genuine and the work is being done by the candidate himself.
Chief Guide: Dr. Sankalp
ASSISTANT PROFESSOR
CTVS DEPARTMENT
AIIMS RAEBARELI

Co-Guide Dr. Niraj Kumar Srivastava

ASSOCIATE PROFESSOR
GENERAL SURGERY DEPARTMENT
AIIMS RAEBARELI

4
 TABLE OF CONTENTS
S.No CONTENTS PAGE NO

1. INTRODUCTION 6

2. REVIEW OF LITERATURE 8

3 RATIONALE OF STUDY 18

4. AIMS AND OBJECTIVES 20

5. MATERIALS AND METHODS 21

6. STATISTICAL ANALYSIS 25
PLAN
7. STUDY FLOWCHART 26

8. ANNEXURES 27

9. REFERENCES 29

10. CASE PROFORMA 34

11. PARTICIPANT INFORMATION 40

SHEET ( ENGLISH )
12. PARTICIPANT INFORMATION 42
SHEET ( HINDI )
13. INFORMED CONSENT 44
(ENGLISH)
14 INFORMED CONSENT (HINDI) 45

5
 THESIS PROTOCOL

INTRODUCTION

Venous ulcer disease(VUD) is a most severe

manifestation of chronic venous insufficiency, classified
as class 5 & 6 according to CEAP clinical classification.
The etiopathogenesis behind VLUs includes long
standing venous hypertension that may be secondary to
calf muscle pump failure, venous reflux through
incompetent valves, postthrombotic sequelae etc.
Amongst all lower extremity ulcers, ulcers due to chronic
venous insufficiency account for the majority of cases and
often the treatment outcome gets hindered due to
misdiagnosis or presence of additional pathologies
resulting in non-healing or recurrence. Therefore, it is
crucial to study the factors that would result in delayed
healing or recurrence. One of the factors known to be
associated with non-healing venous leg ulcer (VLU) is co-
6
existing Lower Extremity Arterial Disease (LEAD). Even
though the pathophysiology of both lower limb venous
and arterial insufficiency is different, they present with
overlapping symptoms or may present at the same time.
The term ‘MIXED ULCERS’ is used for ulcers presenting
with both venous and arterial insufficiency. Majority of
patients with minor LEAD may not manifest classical
clinical features of lower limb ischemia hence it becomes
important to screen patients with sub clinical LEAD in
patients with concomitant venous ulcer disease to
prevent recurrence and non-healing. While mixed ulcers
are a well-recognized clinical entity associated with poor
prognosis, its prevalence is not well studied in India. In
this study we shall be studying the prevalence of LEAD in
patients of venous ulcer disease using ABPI which is first
line non-invasive testing modality for screening and
diagnosing LEAD.

7
 REVIEW OF LITERATURE
Chronic leg ulcer is defined as defect in the skin
below the level of knee persisting for more than 6
weeks and shows no tendency to heal. [1][2]
Aproximately 70% of leg ulcers are caused by venous
hypertension.Conversely, approximately 10% are
arterial in origin, and are caused by:
● Peripheral arterial disease
● Thrombosis
● Compromised microcirculation due to rheumatoid
arthritis, diabetes and autoimmune diseases.
Of the remaining 20% of ulcers, 15% have a combination of
arterial and venous incompetence (CAVI) [3], 4 and 5% result
from more unusual causes.

VENOUS ULCER

According to the CEAP classification, revised in 2020, a venous

leg ulcer (VLU) is defined as a full-thickness skin defect, most
frequently in the lower leg and ankle region that fails to heal
spontaneously and is sustained by venous hypertension due to
chronic venous disease[4]. Ulceration may be secondary to
either reflux or obstruction in the venous system. On clinical
examination-Venous ulcers are single to multiple lesion often
8
located in Lower part of leg in gaiters area( anterior to medial
malleolus); usually never seen above the junction of middle and
upper 1/3rd of leg and can be of any size and shape. The edge is
irregular, sloping and purple in colour, margin is thin, blue and
made up of growing epithelium. The floor is made of pale
granulation tissue. Ulcer is shallow and never penetrates deep
fascia but base of ulcer is fixed to deeper structures. The
surrounding skin shows sign of chronic venous hypertension,
which includes tenderness, pigmentation and induration.
It may be difficult to differentiate between reflux and
obstruction on clinical grounds alone.

Overall burden of venous ulcer disease and economic

impact:
Venous leg ulcers account for the most common type of lower
extremity ulcer disease [5].
Prevalence of VUD is approximately 2% of the population and
increases with age around 5% for people >65 years of age. [6][7]
Major burden of venous ulcer disease occurs due to longer
duration of healing , regular follow-ups, wound care and timely
dressing which impacts the patients physically, mentally,

9
socially and economically. In a study conducted by Harrison
MB et al. found out in 2001 that up to 93% of venous leg ulcers
will heal in 12 months, with 7% remaining unhealed after 5
years.[8]

However, studies to estimate the incidence and overall

socioeconomic burden of chronic venous disease in India are
limited. An epidemiological study carried out in in 1972 Indian
railroad workers determined the prevalence of varicose veins to
be 25% in southern and 6.8% in northern India [9]. Another
study conducted in Mangalore on 170 varicose vein cases
admitted in tertiary care hospitals between May 2011 and April
2014, showed that ulceration was the most common symptom at
the time of presentation i.e., 98 patients out of 170 presented
with venous leg ulcers (57.6%) [10].

It is untrue to say that venous illness is less common in Indian

environments. An increasing number of studies are required to
investigate the epidemiology of certain issues, particularly
patients presenting with CAVI or MAVLU.

10
Risk factors for venous ulcer disease:
Risk factors for developing VLUS include advancing age,
female gender, multiparity, heredity, history of trauma to the
extremity and prolonged standing. Lindsay Robertson et al in
their study showed that increased risk of ulceration in chronic
venous insufficiency was associated with history of DVT, higher
body mass index, presence of skin changes
(lipodermatosclerosis, corona phlebetica and eczema) limited
range of ankle movement.[11].

LOWER EXTREMITY ARTERIAL DISEASE

Lower extremity arterial disease (LEAD) is categorized into four

stages based on clinical symptoms, according to the Fontaine
classification: stage I is asymptomatic; stage IIa is non-disabling
intermittent claudication; stage IIb is disabling intermittent
claudication; stage III is ischemic rest pain; and stage IV is
ulceration or gangrene.
As compared to venous ulcers, arterial leg ulcer are rare and
occurs due to peripheral arterial disease and poor circulation. In
contrast to venous ulcers, arterial ulcers appear to have been
11
punched out during clinical examination, exposing tendons,
bone, and other deep structures. They Usually presents on
anterior and outer aspects of the leg, dorsum of the foot, toes or
heel and generally below level of medial malleolus
differentiating it from venous ulcers which present above the
level of medial malleolus.
Majority of people suffering from LEAD are asymptomatic so it
becomes important to screen people well in advance before
irreversible damage due to ischemia occurs which can be done
using ABPI.
Ankle brachial pressure index (ABPI) Is a non-invasive method
for screening and diagnosing Lower extremity arterial disease
(LEAD).An ABPI <0.09 HAS 86% Specificity and 75%
sensitivity to diagnose LEAD therefore It can be used as 1st line
diagnostic test to screen and diagnose LEAD after thorough
clinical examination. [12].
ABPI Is measured In supine position, with cuff placed just
above the ankle, avoiding wounded zones. After a 5–10 minute
rest, the SBP is measured by a Doppler probe (5–10 MHz) on
the posterior and the anterior tibial (or dorsal pedis) arteries of
each foot and on the brachial artery of each arm. Automated BP
12
cuffs are mostly not valid for ankle pressure and may display
overestimated results in case of low ankle pressure. The ABI of
each leg is calculated by dividing the highest ankle SBP by the
highest arm SBP.
Based on the value of ABPI calculated using above method,
patients can be classified into abnormal high ( 1.40) normal
(1.0-1.40), borderline (0.9-1.0), Abnormal low ( 0.9).

MIXED ULCERS

As mentioned above out of total chronic ulcers, approximately

15% occurs due to both chronic arterial and venous
insufficiency known as CAVI ( Chronic arterial and venous
insufficiency) [13] and ulcers presenting with both arterial and
venous insufficiency are referred as MAVLU (mixed arterial
venous leg ulcer) [14] .Venous insufficiency required the
presence of characteristic and duplex findings. These
requirements included the presence of oedema,
hyperpigmentation, varicose veins ,or skin induration in addition
to skin breakdown. On duplex examination, reflux or thrombosis
was required in either the GSV or deep veins of the affected

13
extremity whereas chronic arterial insufficiency was defined as
ABPI <0.9. [13]

RECURRENCE AND NON-HEALING LEG

ULCERS:
If not treated adequately, VLU could progress to non-healing
VLUs, causing physical immobility, decreases quality of life,
severe infections cellulitis , osteomyelitis, and sometimes
neoplastic transformation (Marjolin ulcer). If not associated with
any comorbidities, venous ulcers show good rates of healing
with proper compression therapy and good wound care.
However, major problem with venous ulcers is that their
recurrence rates are very high as 50-70% at 6 months of age [5].
Both these issues account for overall increased socio-economic
burden on both patients and healthcare.

TREATMENT OF VENOUS ULCERS

Treatment of venous ulcer requires a multidisciplinary approach
to deal with various conditions like underlying chronic venous
hypertension, calf pump failure etc, and optimize the treatment

14
according to other factors contributing to poor wound healing
However, the key principles can be summarised as: patients with
active venous ulceration undergo:

1) Objective arterial assessment.

2) Treat the cause venous hypertension
3) Compression therapy

 Small and recent onset ulcer: superimposed ECS  40mmhg at the

ankle
 Multilayer, inelastic bandages or ACG  40mmhg at the ankle.
 Mixed ulcer: compression < 40 mmhg under close supervision

4) Additional intervention –

 adjuvant pharmacotherapy
 systemic or local antibiotics if infection is present.
 Improve mobility and ankle stiffness [15]

TREATMENT OF MIXED ULCERS

Patients with VLUs often have associated co-morbidities [16]

Which commonly contributes to poor wound healing and results
in non-healing ulcer. So it becomes important to expand the
clinical examination and treatment strategies in order to
optimize systemic medical issues to promote healing. Of all the
systemic diseases, presence of LEAD (lower extremity arterial
disease) becomes particularly relevant as it not only hinders the

15
overall healing, but also changes the treatment strategy.
Therefore, basic assessment of lower limb arteries should be
done using ABPI. An ABPI of >0.8 maybe considered as normal
and permits the use of compression therapy according to
standard care of management [17]
The use of compression stockings in patients with ABPI <0.8 is
disputable as it may cause more harm to patient than good as it
may result in iatrogenic skin damage in presence of arterial
disease. If the absolute value of ankle pressure > 60mmhg, toe
pressure >30mmhg and ABPI> 0.6, modified compression
therapy can be given using short stretch material with a pressure
 40mmhg can prove to be very effective in healing of mixed
ulcers. [18] [19]

In a study conducted by Clarke-Moloney M. et al in 2014 it was

shown that patient who were compliant with compression
stockings reported lowest VLU recurrence rate regardless of the
compression pressure/level used.[20]

The higher the compression pressure, the lower the recurrence

rates were seen [21] but , in cases of mixed ulcers with APBI
<0.6 use of high pressure compression stockings is
16
contraindicated [22]. It should also be noted that higher the
pressure, the lower the compliance of patients for ECS.[23]
Therefore, it should be kept in mind while treating mixed ulcers
that due to these reasons it might get difficult to treat mixed
ulcers and also increased chances of recurrence and/or non-
healing can be seen.

17
 RATIONALE OF THE STUDY

It is estimated that 10% of Indian population shall suffer from

leg ulceration sometime in life [1], with the community based
prevalence of 4.5/1000 population [24]. Both in Indian and
Western population, chronic venous insufficiency accounts for a
major portion of these patients, with lower limb arterial disease
following as close second with advancing age of persons.
Studies done in India have found a major variation in occurrence
of chronic venous insufficiency in different parts of
India(Khanna). The incidence of LEAD rises with advancing
age, yet it is also found to occur at lower rates in Indian
population as per community based studies(kerela, tamil nadu
study). Leg ulcer with co-existing CVI and LEAD are often
called as ‘mixed ulcers’. The cornerstone of VLU treatment
remains compression therapy, and it often exacerbates co
existing subclinical arterial insufficiency, resulting in poorer
healing rates. This leads to increased morbidity and Disability
Adjusted Life Years (DALY). There is dearth of literature in
North Indian population on venous ulcer disease in general and
on mixed ulcers in particular. Nag et al have reported a

18
prevalence of 27.71% for mixed ulcers in Eastern Indian
population with a median age of 45 years. Our clinical
experience suggests that the figure in North Indian population
may be much lower.[25]
This prospective observational study shall assess, in the setting
of CTVS and General Surgery OPDs, the associated risk factors
in general and the prevalence of mixed ulcers in North Indian
population suffering from VLU, via a combination of history
taking, clinical examination and ABPI assessment, A significant
prevalence of mixed ulcers should warrant a change in
investigative protocol, making ABPI assessment routine
investigation in patients presenting with CVI in our patient base.
Also, the knowledge of concomitant LEAD will help in
management and prognostication/counselling of the patient. This
study will also shed light on the various risk factors associated
with VLU, any variations with other populations and may
indicate additional preventive as well as therapeutic avenues.

19
 AIMS AND OBJECTIVES

Primary Objective-
 To determine the prevalence of LEAD in patients with
venous leg ulcer (VLU).

Secondary objective-
 To assess various associated risk factors in patients
with venous ulcer disease.

20
 MATERIALS AND METHODS

Study design
Prospective observational study

Study setting
CTVS/ General surgery Out Patient Department of AIIMS
Raebareli

Study population
Patients attending AIIMS Raebareli CTVS and GENERAL
SURGERY OPD diagnosed as case of CHRONIC VENOUS
INSUFFICIENCY with VENOUS ULCER DISEASE.

Inclusion criteria:
All patients more than 18 years of age with venous ulcer disease
attending CTVS/General surgery OPD at AIIMS RAEBARELI

Exclusion criteria:
Pregnant patient

21
Patient with cardiac disease/limb disease which does not permit
the use of ABPI.

Sample size
All patients attending OPD who fulfill inclusion criteria shall be
counselled and those who fulfil study criteria and those who
consent shall be included in the study.

Study Procedure
 Patients fulfilling the inclusion & exclusion criteria will be
considered for participation as study subjects.
 Before their final enrolment for the study, they will be
informed regarding the procedure that will be performed
(ABPI) and thereafter written informed consent will be
taken.

Data will be collected as follows:

 Baseline information and Epidemiological factors-
Age, BMI, occupation, family history, smoking history,
history of alcohol intake, any comorbidities, detail of any

22
 treatment for current illness or any previous operative
procedure done (if any)
 Clinical factors and examination findings-
Clinical assessment of the study subject will be done.
 Patient reported outcomes (PRO) Tools-
ABPI (Ankle brachial pressure index).

 Patient will be evaluated using ABPI for screening LEAD .

 VLU: Venous Ulcer Disease: Patient with chronic leg

ulcer clinically assessed as secondary to chronic venous
insufficiency based on
o Location- gaiter area
o Surrounding pigmentation/eczema/lipodermatosis
o Presence of varicose veins
o History consistent with previous deep venous
thrombosis or active chronic insufficiency
o Supporting radiological evidence like venous
duplex study

23
 LEAD: Lower Extremity Arterial Disease: Arterial
insufficiency in lower limbs
 Mixed Ulcer: ulcer with features of chronic venous
insufficiency and lower extremity arterial disease
identified as
o chronic venous insufficiency
 classical clinical findings
 venous duplex documenting venous
reflux/deep venous thrombosis
o lower extremity arterial disease
 ankle brachial pressure index of <0.9

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 STATISTICAL ANALYSIS PLAN

 The data collected in Case Proforma for each patient shall

be entered in Microsoft excel sheet.
 and will be transferred to SPSS software
 The quantitative data will be presented as mean, median
and standard deviation (as applicable).
 Descriptive categorical data will be presented as frequency,
percentage and proportions (as applicable).
 To assess significant difference in mean values, Students t-
test will be used.
 Any association between descriptive categorical data will
be assessed using CHI- Square test.
 A p value <0.05 will be considered statistically significant.

25
 STUDY FLOWCHART
Patients with CVI presenting with
venous ulcer disease attending
CTVS/GENERAL SURGERY OPD
will be taken up for study

Based on the clinical findings, it will

be assessed whether patient has CVI
with VENOUS ULCER

Based on the Clinical features,

diagnosis of CVI with VENOUS
ULCER disease will be made

INCLUSION CRITERIA

EXCLUSION CRITERIA

INFORMED
CONSENT

FINAL ENROLLED
STUDY PARTICIPANTS

Data recorded on Case Proforma sheet-

Basic info, epidemiological factors,
clinical and investigative findings.

 Patient then shall thereafter undergo

ankle brachial pressure index
measurements (ABPI)
26
 ANNEXURE
ABPI INTERPRETATION:

27
Table: The 2020 update of the CEAP (Clinical Etiological Anatomical
Pathophysiological) classification6
Class Description
Clinical (C) class
C0 No visible or palpable signs of venous disease
C1 Telangiectasia or reticular veins
C2 Varicose veins
C2r Recurrent varicose veins
C3 Oedema
C4 Changes in skin and subcutaneous tissue secondary to CVD
C4a Pigmentation or eczema
C4b Lipodermatosclerosis or atrophie blanche
C4c Corona phlebectatica
C5 Healed ulcer
C6 Active venous ulcer
C6r Recurrent venous ulceration
Symptomatic or not: subscript ‘S’ S: symptomatic, including ache, pain, tightness, skin
irritation, heaviness, and muscle or subscript ‘A’ cramps, and other complaints attributable
to venous dysfunction

A: asymptomatic
Etiological (E) class
Ep Primary
Es Secondary
Esi Secondary e intravenous
Ese Secondary e extravenous
Ec Congenital
En None identified
Anatomical (A) class
As Superficial
Ad Deep
Ap Perforators
An No identifiable venous location
Pathophysiological (P) class*
Pr Reflux
Po Obstruction
Pr,o Reflux and obstruction
Pn No pathophysiology identified

28
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Indian railroad workers from the South and North of India,
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10. Joseph N, Abhishai B, Thouseef MF, Abna A, Juneja
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 Graaf R, Hamel-Desnos C, Jawien A. Editor's choice–
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16. Jockenhö fer F, Gollnick H, Herberger K, Isbary G,
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ABPI reporting and compression recommendations in
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20. Clarke‐Moloney M, Keane N, O'Connor V, Ryan MA,
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33
 CASE PROFORMA
1. Patient Demographics –

Serial number CR number

Name Age

Address Gender

BPL status
(income <
Occupation Yes No
27000 in year)

Contact
Literate Yes No
number

2. Chief complaints-
Duration of ulcer:
Location of ulcer:
Claudication:
Rest pain:
Other complaints

34
3.Clinical factors –

H/O STATUS
History of prolonged standing (yes / no)
History of pain while walking, relieved with rest (yes / no)
History of recurrent leg ulcers (yes / no)
History Of Numbness (yes / no)
History of Calf tenderness (yes / no)
History of Cramps (yes / no)
History of bleeding (yes / no)
Diabetes mellitus (yes / no)
Hypertension (yes / no)
Coronary artery disease (yes / no)
Hypercholesterolemia (yes / no)
Chronic kidney disease (yes / no)
Smoking/smokeless tobacco use (yes / no)
Obesity (On Basis Of BMI); HEIGHT-
WEIGHT- (yes / No)
BMI=
Any treatment taken for current illness or any previous
operative procedure done (yes / No)

35
 3. Physical examination
SIZE AND SHAPE:
NUMBER:
LOCATION:
EDGE:
MARGIN:
FLOOR:
DISCHARGE:
SURROUNDING AREA:
ECZEMA/ PIGMENTATION/ LIPODERMATOSCLEROSIS/ EDEMA
PRESENCE OF VARICOSE VEINS:
PRESENSE OF EQUINUS DEFORMITY:
VENOUS TERRITORY INVOLVED:

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 4. Index blood investigations (as available)
Hemoglobin
TLC
HbA1C
Total cholesterol
LDL cholesterol
HDL cholesterol
Serum creatinine

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 5. Other Investigations

Culture –

Sensitivity-
Bacterial C/S

USG-VENOUS
Findings-
DUPLEX SCAN

6. CEAP STAGE –

7. ABPI –

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8. Any other relevant Investigations available

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 Participant Information Sheet [PIS]
Title of Research –
Clinical study of venous ulcer disease and assessment of co-existing
Lower Extremity Arterial Disease (LEAD) using Ankle Brachial
Pressure Index (ABPI)

Principal Investigator: Dr. Aseshta Sharma

 We invite you to participate in this research. This information
sheet will guide you and help you decide whether to be a part of
this research. In this research, our objective is to determine the
Prevalence of LEAD in patients of chronic venous insufficiency
presenting with venous leg ulcer using ABPI along with associated
risk factors for venous ulcer disease.
 I will be happy to clear any doubts you have regarding this
research.

What is your expected duration of participation?

Your participation in this research will last for a total of .

What procedures will be followed during this research?

The research will involve collecting data from the standard care of
treatment and investigations done by practising physician for your
venous ulcer disease along with Measuring ABPI.

What are the risks and discomforts to you?

There will be no risk of the procedure to you.

What benefits are expected from this research?

This research may help you, as you will undergo screening for LEAD

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which is one of a cause for non -healing ulcers. Early diagnosis of
concomitant LEAD will guide the treating physician to modify your
treatment accordingly. It also helps others by assessing various risk
factors associated with venous ulcer disease.

What are the alternatives available to you?

You may receive standard treatment for your disease symptoms without
participating in the research.

Will your records be kept confidential?

The personal and medical records of yours will be kept confidential
accessible only to the investigators. Your identity will not be revealed in
any information released to third parties or published.

What compensation and treatment are available to you in case of a

research-related injury?
No increased risk of injury is expected in this study, as already research-
approved standard treatment is given to you. However, all treatment-
related complications will be managed. No monetary compensation will
be given.

What are the rights of yours in the event of any injury?

You have the right to withdraw from the research and get medical
attention in case of research-related injury.

Will you be paid to take part in this research?

No monetary benefit will be given to you for participating in the
research.

Where will the tests be done, and who will pay for them?

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All tests performed are part of standard treatment protocol followed at
our department. No additional tests will be done.

What are your responsibilities during participation in the study?

You are expected to provide honest answers to the best of your
knowledge and recall along with treatment records and investigation
reports for data collection.

Voluntary Participation.
Your participation in this research is entirely your choice. If you choose
not to participate in this research, you will be offered the standard
treatment routinely given in this hospital for your disease.

Who to Contact for research-related queries?

In case of any queries during the research, you can contact the
investigators.
Principal investigator: Dr. Aseshta Sharma
(Mobile number:9960765081)

Chief guide: Dr. Sankalp

(Mobile number: 7760064121)

Member secretary of Ethics Committee: Dr. (Prof.) Rajat Shubra das

(Mobile number:9436540949)
Roomnumber:122,Second floor,
Medical college building
AIIMS Raebareli
Signature of PI:
Date:
Signature of Guide:

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 INFORMED CONSENT

I have been told in detail about the study in AIIMS Raebareli Medical College &
Hospital by Dr …....................... Detailed information has been given to me about
the symptoms of the disease and related investigations and treatment. I have been
made aware about the benefits and side effects related to the investigations and
intake of medicines. This study will result in new knowledge that will be beneficial
to mankind.
In relation to this study all points have been explained to me in detail in my own
language and i got the opportunity to ask questions and satisfactory answers were
provided to me. I willingly give my approval for being a part of the study and I am
told that I can opt out of this study anytime without giving any explanation.

Name and Signature of Investigator .......................................................

Name and Signature of patient/guardian .................................................

सहमति पत्र

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मुझे एम्स, रायबरेली मेडिकल कालेज एवं अस्पताल में होने वाले अध्ययन के बारे में
डा......................................... द्वारा विस्तार से जानकारी दे दी गयी है। मुझे इस रोग के
लक्षण एवं उससे सम्बन्धित जाँच एवं इलाज के बारे में विस्तृत जानकारी दे दी गयी है। मुझे जांच
एवं दवाईयों के सेवन से होने वाले लाभ एवं दुष्परिणामों से अवगत करा दिया गया है। इस अध्ययन
से नया ज्ञान प्राप्त होगा जो मानव जाति के लिए लाभप्रद होगा।
मुझे इस शोध से सम्बन्धित सारे बिन्दुओं का सम्पूर्ण विवरण मिल गया है और मुझे प्रशन पूछने का
अवसर प्रदान किया गया और सन्तोषजनक उत्तर दिए गए ।मैं स्वेच्छा से व सहर्ष इस अध्ययन में
सम्मिलित होने की मंजूरी देता हूँ। मुझे बता दिया गया है कि मैं जब चाहूँ बिना बताए इस शोध
अध्ययन से हट सकता हूँ।

अध्ययनकर्ता का नाम एवं हस्ताक्षर

रोगी / अभिभावक का नाम एवं हस्ताक्षर

THANK YOU.

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