Back to resultsEvaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers (HEAL I)
Primary Purpose
Venous Leg Ulcer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cirvo™ Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring mobile compression device
Eligibility Criteria
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
Sites / Locations
- Zuckerberg San Francisco General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cirvo™ Therapy
Arm Description
Outcomes
Primary Outcome Measures
Percent of subjects fully healed at 12 weeks
Secondary Outcome Measures
Percent of wound epithelialized at 12 weeks
Percent of subjects fully healed at 4 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03544788
Brief Title
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
Acronym
HEAL I
Official Title
HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision
Study Start Date
June 30, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radial Medical, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
mobile compression device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cirvo™ Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cirvo™ Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cirvo™ Therapy
Intervention Description
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 Measure Information:
Title
Percent of subjects fully healed at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent of wound epithelialized at 12 weeks
Time Frame
12 weeks
Title
Percent of subjects fully healed at 4 weeks
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Time to complete healing in fully-healed subjects
Time Frame
12 weeks
Title
Therapy-related adverse events will be collected throughout the 12-week study period
Time Frame
12 weeks
Title
Characterization of Quality of Life measured using the EQ-5D-5L
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Characterization of Quality of Life measured using the WPAI:GH
Description
WPAI:GH: Work Productivity and Activity Impairment: General Health
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Characterization of Disability measured using the VLU-QoL
Description
VLU-QoL: Venous Leg Ulcer Quality of Life Instrument
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Characterization of Disability measured using the VCSS
Description
VCSS: Venous Clinical Severity Score
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey
Time Frame
Baseline, 4 weeks, 12 weeks
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
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