Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers

NCT03544788 | Withdrawn FDA Device

• 1 other identifier: RMP-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Keywords

mobile compression device

Outcome Measures

Primary Outcomes (1)

• Percent of subjects fully healed at 12 weeks

  12 weeks

Secondary Outcomes (2)

• Percent of wound epithelialized at 12 weeks

  12 weeks

• Percent of subjects fully healed at 4 weeks

  4 weeks

Other Outcomes (10)

• Time to complete healing in fully-healed subjects

  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

Study Arms (1)

Cirvo™ Therapy

EXPERIMENTAL

Device: Cirvo™ Therapy

Interventions

Cirvo™ Therapy DEVICE

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).

Cirvo™ Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radial Medical, Inc.: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cirvo™ Therapy

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 4, 2018
• Study Start: June 30, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)