Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers (HEAL I)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Cirvo™ Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cirvo™ Therapy	Device: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete healing in fully-healed subjects		12 weeks
Therapy-related adverse events will be collected throughout the 12-week study period		12 weeks
Characterization of Quality of Life measured using the EQ-5D-5L		Baseline, 4 weeks, 12 weeks
Characterization of Quality of Life measured using the WPAI:GH	WPAI:GH: Work Productivity and Activity Impairment: General Health	Baseline, 4 weeks, 12 weeks
Characterization of Disability measured using the VLU-QoL	VLU-QoL: Venous Leg Ulcer Quality of Life Instrument	Baseline, 4 weeks, 12 weeks
Characterization of Disability measured using the VCSS	VCSS: Venous Clinical Severity Score	Baseline, 4 weeks, 12 weeks
Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey		Baseline, 4 weeks, 12 weeks
Measurement of compliance with Cirvo(TM) (a minimum of 2 hours of therapy daily for up to 12 weeks) - number of days of therapy use		12 weeks
Measurement of compliance with Cirvo(TM) (a minimum of 2 hours of therapy daily for up to 12 weeks) - hours per day of therapy use		12 weeks
Reasons for Cirvo(TM) discontinuation prior to complete healing (including, but not limited to: adverse events, self-withdrawal) will be tabulated		12 weeks

Collaborators and Investigators

• Sponsor: Radial Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: mobile compression device
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: RMP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No