Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers

Withdrawn before enrolling · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.

Key facts

Study ID

NCT03544788

Run by

Radial Medical, Inc.

People needed

0

Starts

2019-06-30

Expected to finish

2020-02-01

Last updated by the study team

2019-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients between 18 and 80 years of age
• Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
• Total venous ulcer area < 20cm2
• Duration of therapy for active venous ulcer <26 weeks prior to enrollment
• Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system

You may not qualify if…

• Acute DVT within the 3 months prior to enrollment
• Ulcer present for <2 weeks
• Ulcers extending with exposed fascia, tendon, or bone within the wound margins
• Lateral malleolus ulcers
• Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
• Active infection (systemic or in the affected limb)
• Lower extremity gangrene
• Diabetes mellitus (Type I or II) requiring medication
• History of pulmonary vascular disease (PVD)
• History of pulmonary edema
• History of decompensated congestive heart failure (CHF)
• Open surgery or major trauma to the legs within the last six months
• History of lower limb malignancy, primary or secondary
• Acute symptomatic lower extremity thrombophlebitis
• Pregnant or breastfeeding
• Calf geometry on which Cirvo(TM) device does not appropriately fit
• Known sensitivity to any of the materials used in the Cirvo(TM) device
• Currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer

Where it is running

• Zuckerberg San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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