Perforator Vein Injection for Symptomatic Venous Disease

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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. sclerotherapy of refluxing perforating veins with compression.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ellen Dillavou
• Collaborator: American College of Phlebology
• Treatments: Sodium Tetradecyl Sulfate

Criteria

Inclusion Criteria:

• • 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 Criteria:

• • 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