Venous Leg Ulcer
Conditions
Keywords
mobile compression device
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.
Interventions
DEVICECirvo™ 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).
Sponsors
Radial Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cirvo™ Therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects fully healed at 12 weeks | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of wound epithelialized at 12 weeks | 12 weeks |
| Percent of subjects fully healed at 4 weeks | 4 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characterization of Quality of Life measured using the WPAI:GH | Baseline, 4 weeks, 12 weeks | WPAI:GH: Work Productivity and Activity Impairment: General Health |
| Characterization of Disability measured using the VLU-QoL | Baseline, 4 weeks, 12 weeks | VLU-QoL: Venous Leg Ulcer Quality of Life Instrument |
| Characterization of Disability measured using the VCSS | Baseline, 4 weeks, 12 weeks | VCSS: Venous Clinical Severity Score |
| Time to complete healing in fully-healed subjects | 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 | — |
| Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey | Baseline, 4 weeks, 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 | — |
Countries
United States
Outcome results
None listed