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

Study Overview
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Brief Summary
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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.

Official Title
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HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Cirvo™ Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cirvo™ Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cirvo™ Therapy<br> | Device: Cirvo™ Therapy<br>* The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression for the treatment of venous leg ulcers (VLU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects fully healed at 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of wound epithelialized at 12 weeks |  | 12 weeks | 
| Percent of subjects fully healed at 4 weeks |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile compression device