Clinical trial NCT03544788: Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: mobile compression device
Lead sponsor: Radial Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cirvo™ Therapy
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent of subjects fully healed at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent of wound epithelialized at 12 weeks
timeFrame: 12 weeks
measure: Percent of subjects fully healed at 4 weeks
timeFrame: 4 weeks
Other outcomes:
measure: Time to complete healing in fully-healed subjects
timeFrame: 12 weeks
measure: Therapy-related adverse events will be collected throughout the 12-week study period
timeFrame: 12 weeks
measure: Characterization of Quality of Life measured using the EQ-5D-5L
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Characterization of Quality of Life measured using the WPAI:GH
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Characterization of Disability measured using the VLU-QoL
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Characterization of Disability measured using the VCSS
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey
timeFrame: Baseline, 4 weeks, 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Reasons for Cirvo(TM) discontinuation prior to complete healing (including, but not limited to: adverse events, self-withdrawal) will be tabulated
timeFrame: 12 weeks
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
References: