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

NCT ID: NCT03544788

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2020-02-01

Brief Summary

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.

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cirvo™ Therapy

Group Type: EXPERIMENTAL

Cirvo™ Therapy

Intervention Type: DEVICE

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).

Interventions

Cirvo™ Therapy

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female patients between 18 and 80 years of age

2. Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg

3. Total venous ulcer area < 20cm2

4. Duration of therapy for active venous ulcer <26 weeks prior to enrollment

5. Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system

Exclusion Criteria

1. Acute DVT within the 3 months prior to enrollment

2. Ulcer present for <2 weeks

3. Ulcers extending with exposed fascia, tendon, or bone within the wound margins

4. Lateral malleolus ulcers

5. Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)

6. Active infection (systemic or in the affected limb)

7. Lower extremity gangrene

8. Diabetes mellitus (Type I or II) requiring medication

9. History of pulmonary vascular disease (PVD)

10. History of pulmonary edema

11. History of decompensated congestive heart failure (CHF)

12. Open surgery or major trauma to the legs within the last six months

13. History of lower limb malignancy, primary or secondary

14. Acute symptomatic lower extremity thrombophlebitis

15. Pregnant or breastfeeding

16. Calf geometry on which Cirvo(TM) device does not appropriately fit

17. Known sensitivity to any of the materials used in the Cirvo(TM) device

18. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radial Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

RMP-002

Identifier Type: -

Identifier Source: org_study_id