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

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ClinicalTrials.gov Identifier: NCT03544788
Recruitment Status : Not yet recruiting
First Posted : June 4, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Radial Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Cirvo™ Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cirvo™ Therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Percent of subjects fully healed at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percent of wound epithelialized at 12 weeks [ Time Frame: 12 weeks ]
  2. Percent of subjects fully healed at 4 weeks [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. Time to complete healing in fully-healed subjects [ Time Frame: 12 weeks ]
  2. Therapy-related adverse events will be collected throughout the 12-week study period [ Time Frame: 12 weeks ]
  3. Characterization of Quality of Life measured using the EQ-5D-5L [ Time Frame: Baseline, 4 weeks, 12 weeks ]
  4. Characterization of Quality of Life measured using the WPAI:GH [ Time Frame: Baseline, 4 weeks, 12 weeks ]
    WPAI:GH: Work Productivity and Activity Impairment: General Health

  5. Characterization of Disability measured using the VLU-QoL [ Time Frame: Baseline, 4 weeks, 12 weeks ]
    VLU-QoL: Venous Leg Ulcer Quality of Life Instrument

  6. Characterization of Disability measured using the VCSS [ Time Frame: Baseline, 4 weeks, 12 weeks ]
    VCSS: Venous Clinical Severity Score

  7. Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey [ Time Frame: Baseline, 4 weeks, 12 weeks ]
  8. 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 [ Time Frame: 12 weeks ]
  9. 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 [ Time Frame: 12 weeks ]
  10. Reasons for Cirvo(TM) discontinuation prior to complete healing (including, but not limited to: adverse events, self-withdrawal) will be tabulated [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544788


Contacts
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Contact: Tammy Morton, MS 650-209-0973 tmorton@radialmedical.com

Locations
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United States, California
Zuckerberg San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Shant Vartanian, MD       Shant.Vartanian@ucsf.edu   
Sponsors and Collaborators
Radial Medical, Inc.

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Responsible Party: Radial Medical, Inc.
ClinicalTrials.gov Identifier: NCT03544788     History of Changes
Other Study ID Numbers: RMP-002
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Radial Medical, Inc.:
mobile compression device

Additional relevant MeSH terms:
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Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases