| CTRI Number |
CTRI/2025/08/093813 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Minimal Invasive Procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Glue Treatment and Laser Therapy for management of recurrent Varicose Veins |
|
Scientific Title of Study
|
Assessment of Comparative Efficacy of Cyanoacrylate Glue vs Endovenous Laser Ablation for Recurrent Varicose Veins due to Residual / Recurrent Incompetent Perforators - RCT |
| 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 Lalit Kumar Nirwan |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Interventional Radiology JNMC and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU)
Sawangi (Meghe)
Wardha
MAHARASHTRA
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422440440 |
| Fax |
|
| Email |
lalitnirwan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Banode |
| Designation |
Professor & Head of Department, Interventional Radiology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Interventional Radiology JNMC and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU)
Sawangi (Meghe)
Wardha
MAHARASHTRA
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713020 |
| Fax |
|
| Email |
drpjbanode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalit Kumar Nirwan |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Interventional Radiology JNMC and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU)
Sawangi (Meghe)
Wardha
MAHARASHTRA
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422440440 |
| Fax |
|
| Email |
lalitnirwan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Interventional Radiology,
JNMC and Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research (DU),
Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe) |
| Address |
JNMC and Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe)
Wardha 442001
Maharashtra
442001 India |
| Type of Sponsor |
Private medical college |
|
|
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 Lalit Kumar Nirwan |
JNMC and Acharya Vinoba Bhave Rural Hospital |
Cath lab console room, Department of Interventional Radiology, JNMC and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe)
Wardha
MAHARASHTRA |
9422440440
lalitnirwan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyanoacrylate Gel Ablation |
Patients with recurrent varicose veins attending our OPD during the study period considered for the study. Once the patients were diagnosed with recurrent varicose veins on ultrasound, they are included in the study, provided they met the inclusion and exclusion criteria and they gave written informed consent voluntarily. All consecutive patients included till the desired sample size was met. Patents are randomly allocated in to two groups- Laser Group & Glue Group and appropriate treatment provided. |
| Comparator Agent |
Endovenous Laser Ablation |
Patients with recurrent varicose veins attending our OPD during the study period considered for the study. Once the patients were diagnosed with recurrent varicose veins on ultrasound, they are included in the study, provided they met the inclusion and exclusion criteria and they gave written informed consent voluntarily. All consecutive patients included till the desired sample size was met. Patents are randomly allocated in to two groups- Laser Group & Glue Group and appropriate treatment provided. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to sign informed consent form and willing to participate in the study.
2. Patients diagnosed with varicose veins.
3. Patients with a clear history of prior treatment of the varicose veins.
4. Patients who have recurrent perforator as identified by ultrasound.
5. Patients belonging to C3 to C6 classes of the CEAP Classification. |
|
| ExclusionCriteria |
| Details |
1. Patients with deep vein thrombosis.
2. Pregnant and lactating women.
3. Patients with immunocompromised status and terminal illness like cancer.
4. Patients with known allergy to cyanoacrylate adhesive.
5. Patients on treatment with anticoagulants or having any coagulopathy.
6. Patients not ready to consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To compare the closure rates of incompetent perforators at 6 month & 1 year post-procedure, as confirmed via Doppler ultrasound.
- To assess improvement in clinical symptoms using the Venous Clinical Severity Score (VCSS) at 6 month and 1 year. |
6 month and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To analyze the incidence of complications (immediate, at 6 month, and at 1 year) following each treatment modality.
- To compare the average procedure time between n-butyl cyanoacrylate glue and endovenous laser ablation. |
Immediate, 6 month & 1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
INTRODUCTION Varicose veins (VV) of the lower extremities represent a common and symptomatic condition affecting a significant proportion of the adult population. These veins result in chronic discomfort and functional impairment, significantly reducing patients’ quality of life due to symptoms such as pain, fatigue, and venous ulcers. The Society for Vascular Surgery, American Venous Forum, and AmericanVein and Lymphatic Society clinical practice guidelines emphasize the importance of evidence-based approaches for treating varicose veins, particularly endovenous procedures, including thermal and non-thermal ablation techniques. Recurrence of varicose veins after treatment often leads to the reappearance of clinical symptoms, necessitating further intervention. Effective management is crucial for addressing incompetent perforator veins, which are a key factor in such recurrences. The comparative trial aims to evaluate the effectiveness of cyanoacrylate glue (non-thermal) vs endovenous laser ablation (thermal) in patients with recurrent varicosities due to residual / recurrent incompetent perforators vein. |