HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers

Radial Medical, Inc.1 site in 1 countryJune 30, 2019

ConditionsVenous Leg Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Venous Leg Ulcer
Sponsor: Radial Medical, Inc.
Locations: 1
Primary Endpoint: Percent of subjects fully healed at 12 weeks
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2019

End Date

February 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Radial Medical, Inc.

Responsible Party

Sponsor

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