| CTRI Number |
CTRI/2025/09/095426 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding the safer and more effective treatment option for below knee perforators |
|
Scientific Title of Study
|
Comparative study of the safety and efficacy of perforator ligation vs foam
sclerotherapy for below knee perforators |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Shivam |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6361528336 |
| Fax |
|
| Email |
kumar1.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajgopal Shenoy |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845243460 |
| Fax |
|
| Email |
rajgopal.shenoy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan M Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavan.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Kumar Shivam |
| Address |
Department of General Surgery, 3rd
Floor, Smt. Sharada Madhav Pai
OPD, Kasturba Hospital, Manipal, Udupi, Karnataka, India 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kumar Shivam |
Kasturba Medical College and Hospital |
Room no. 8, Department of General Surgery, 3rd
Floor, Smt. Sharada Madhav Pai
OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
6361528336
kumar1.kmcmpl2024@learner.manipal.edu |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I83||Varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18 and above
2.Diagnosed with symptomatic varicose veins with incompetent perforators confirmed by Doppler ultrasound
3.Undergoing perforator ligation or foam sclerotherapy for below knee perforators, irrespective of the simultaneous appropriate above-knee treatment (Trendelenberg’s procedure/RFA/EVLA) |
|
| ExclusionCriteria |
| Details |
1.Pregnant or breastfeeding women
2.Patients with active deep vein thrombosis (DVT) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ
14 questionnaire |
To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ
14 questionnaire at baseline(pre-operatively in person) and at 3 months post-op(via telephonic interview). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of post-operative complications between the two treatment groups
|
clinical examination for post-op complications on POD-2 and first follow up visit |
| To assess and compare the post-operative pain in both treatment groups using VAS scale |
pain evaluation using VAS scale on POD-0 and POD-1 |
| To compare the time to return to normal daily activities in each treatment group |
to be asked to the patients via telephonic interview at 3 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Below-knee varicosities, commonly due to incompetent perforator veins, contribute
significantly to symptoms, skin changes, and long-term disability. There is a need to determine whether surgical or sclerotherapy-based approaches offer better
clinical outcomes, safety, and patient satisfaction. Although perforator ligation and foam sclerotherapy are commonly used to treat varicose
veins, there is no clear consensus in the literature about which treatment method offers
better clinical outcomes. There are variations in success rates, complication profiles and patient satisfaction between
the two procedures. A well-structured study is needed to provide robust, comparative evidence to guide clinical
decision-making. |