Summary

for people ages 18-80 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Venous Leg Ulcer mobile compression device Ulcer Leg Ulcer Varicose Ulcer Cirvo™ Therapy

Eligibility

You can join if…

Open to people ages 18-80

  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

You CAN'T join if...

  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

Location

  • Zuckerberg San Francisco General Hospital not yet accepting patients
    San Francisco California 94110 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Radial Medical, Inc.
ID
NCT03544788
Study Type
Interventional
Last Updated