Status:
TERMINATED
Perforator Vein Injection for Symptomatic Venous Disease
Lead Sponsor:
Ellen Dillavou
Collaborating Sponsors:
American College of Phlebology
Conditions:
Venous Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs. scler...
Detailed Description
Symptomatic venous disease is a widespread problem, affecting millions of patients per year, an estimated 1.0 - 1.5% of the population. This costs up to 1% of the total health care budget1-3. Venous p...
Eligibility Criteria
Inclusion
- • The subject must be \> 18 years of age, male or female
- Subject must be willing and able to wear compression stockings
- Subject must have refluxing perforating veins ≥ 3.0 mm in diameter at the calf level or distally in the affected leg.
- Subject presents with ulceration or other symptoms of venous stasis including:
- rash, swelling, pain, bleeding, recurrent cellulitis
- • The subject must sign a written informed consent, prior to randomization, using a form that is approved by the local Institutional Review Board.
Exclusion
- • Pregnancy
- Known allergy to STS
- Refusal to wear compression stocking
- Untreated significant great or small saphenous reflux
- Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
- Significant arterial disease (ABI \< .8)
- Buergers disease
- Acute superficial thrombophlebitis
- Phlebitis migrans
- Acute cellulitis
- Clinical evidence of active local or systemic infection
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03363633
Start Date
March 1 2010
End Date
October 1 2010
Last Update
February 23 2018
Active Locations (1)
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1
Shadyside Medical Building, Suite 307
Pittsburgh, Pennsylvania, United States, 15232