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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.

Tracking Information
First Submitted Date  ICMJE May 21, 2018
First Posted Date  ICMJE June 4, 2018
Last Update Posted Date March 28, 2019
Estimated Study Start Date  ICMJE June 30, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
Percent of subjects fully healed at 12 weeks [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03544788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • Percent of wound epithelialized at 12 weeks [ Time Frame: 12 weeks ]
  • Percent of subjects fully healed at 4 weeks [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2018)
  • Time to complete healing in fully-healed subjects [ Time Frame: 12 weeks ]
  • Therapy-related adverse events will be collected throughout the 12-week study period [ Time Frame: 12 weeks ]
  • Characterization of Quality of Life measured using the EQ-5D-5L [ Time Frame: Baseline, 4 weeks, 12 weeks ]
  • 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
  • Characterization of Disability measured using the VLU-QoL [ Time Frame: Baseline, 4 weeks, 12 weeks ]
    VLU-QoL: Venous Leg Ulcer Quality of Life Instrument
  • Characterization of Disability measured using the VCSS [ Time Frame: Baseline, 4 weeks, 12 weeks ]
    VCSS: Venous Clinical Severity Score
  • Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
Official Title  ICMJE HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Cirvo™ Therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Leg Ulcer
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Cirvo™ Therapy
Intervention: Device: Cirvo™ Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammy Morton, MS 650-209-0973 tmorton@radialmedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03544788
Other Study ID Numbers  ICMJE RMP-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radial Medical, Inc.
Study Sponsor  ICMJE Radial Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Radial Medical, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP