Perforator Vein Injection for Symptomatic Venous Disease

Stopped early · Not applicable

Conditions studied: Venous Disease

In brief

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. sclerotherapy of refluxing perforating veins with compression.

Key facts

Study ID

NCT03363633

Run by

Ellen Dillavou

People needed

12

Starts

2010-03-01

Expected to finish

2010-10-01

Last updated by the study team

2018-02-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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

Where it is running

• Shadyside Medical Building, Suite 307 — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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