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

Radial Medical

Status: Withdrawn

Conditions: Venous Leg Ulcer

Treatments: Device: Cirvo™ Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03544788

RMP-002

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Cirvo™ Therapy

Experimental group

Treatment:

Device: Cirvo™ Therapy