is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?

November 30, 2020 updated by: Dr Anum Arif, Combined Military Hospital, Pakistan
. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.

we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Select A State Or Province
      • Lahore, Select A State Or Province, Pakistan, 0092
        • Recruiting
        • Anum Arif
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy

Exclusion Criteria:

  • recurrent and secondary varicose veins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTERVENTION GROUP
SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT
Drug: Sodium Tetradecyl Sulfate
DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL
Other Names:
  • STS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain by VAS score
Time Frame: 1 MONTH
pain by VAS score
1 MONTH
leg edema
Time Frame: 1 MONTH
leg edema
1 MONTH
cosmesis
Time Frame: 1 MONTH
cosmesis
1 MONTH
cost effectiveness
Time Frame: 1 MONTH
cost effectiveness
1 MONTH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital, Pakistan

Investigators

  • Principal Investigator: Anum Arif, Combined Military Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Anticipated)

February 21, 2021

Study Completion (Anticipated)

February 21, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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