Back to resultsis Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
Primary Purpose
Pain, Leg Edema, Cost Effectiveness
Status
Unknown status
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Sodium Tetradecyl Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
- Anum ArifRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INTERVENTION GROUP
Arm Description
SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT
Outcomes
Primary Outcome Measures
pain by VAS score
pain by VAS score
leg edema
leg edema
cosmesis
cosmesis
cost effectiveness
cost effectiveness
Secondary Outcome Measures
Full Information
NCT ID
NCT04655417
First Posted
November 13, 2020
Last Updated
November 30, 2020
Sponsor
Combined Military Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04655417
Brief Title
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
Official Title
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
February 21, 2021 (Anticipated)
Study Completion Date
February 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Leg Edema, Cost Effectiveness, Cosmesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INTERVENTION GROUP
Arm Type
Experimental
Arm Description
SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT
Intervention Type
Drug
Intervention Name(s)
Sodium Tetradecyl Sulfate
Other Intervention Name(s)
STS
Intervention Description
DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL
Primary Outcome Measure Information:
Title
pain by VAS score
Description
pain by VAS score
Time Frame
1 MONTH
Title
leg edema
Description
leg edema
Time Frame
1 MONTH
Title
cosmesis
Description
cosmesis
Time Frame
1 MONTH
Title
cost effectiveness
Description
cost effectiveness
Time Frame
1 MONTH
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Arif, MBBS FCPS
Phone
+923422398424
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
AHSIN BHATTI, MBBS FCPS
Phone
+923422398424
Email
AHSINMB@YAHOO.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anum Arif
Organizational Affiliation
Combined military hospital lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anum Arif
City
Lahore
State/Province
Select A State Or Province
ZIP/Postal Code
0092
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anum Arif, MBBS FCPS
Phone
03422398424
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ammad Asim, BCS MBA
Phone
03333052892
Email
AMMADASIM@GMAIL.COM
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
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