NCT04655417

Brief Summary

. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for early_phase_1 pain

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2021

Completed
Last Updated

December 7, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 13, 2020

Last Update Submit

November 30, 2020

Conditions

PainLeg EdemaCost EffectivenessCosmesis

Outcome Measures

Primary Outcomes (4)

  • pain by VAS score

    pain by VAS score

    1 MONTH

  • leg edema

    leg edema

    1 MONTH

  • cosmesis

    cosmesis

    1 MONTH

  • cost effectiveness

    cost effectiveness

    1 MONTH

Study Arms (1)

INTERVENTION GROUP

EXPERIMENTAL

SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT

Drug: Sodium Tetradecyl Sulfate

Interventions

Sodium Tetradecyl SulfateDRUG

DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL

Also known as: STS
INTERVENTION GROUP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • recurrent and secondary varicose veins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anum Arif

Lahore, Select A State Or Province, 0092, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Sodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipids

Study Officials

  • Anum Arif

    Combined military hospital lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anum Arif, MBBS FCPS

CONTACT

+923422398424dranumarif@yahoo.com

AHSIN BHATTI, MBBS FCPS

CONTACT

+923422398424AHSINMB@YAHOO.COM

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anum Arif

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 7, 2020

Study Start

February 21, 2020

Primary Completion

February 21, 2021

Study Completion

February 21, 2021

Last Updated

December 7, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)