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

Venous Leg Ulcer Clinical Trial

— HEAL I  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03544788
• Other study ID #: RMP-002
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2019
• Source: Radial Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Cirvo™ Therapy
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).

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Radial Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to complete healing in fully-healed subjects		12 weeks
Other	Therapy-related adverse events will be collected throughout the 12-week study period		12 weeks
Other	Characterization of Quality of Life measured using the EQ-5D-5L		Baseline, 4 weeks, 12 weeks
Other	Characterization of Quality of Life measured using the WPAI:GH	WPAI:GH: Work Productivity and Activity Impairment: General Health	Baseline, 4 weeks, 12 weeks
Other	Characterization of Disability measured using the VLU-QoL	VLU-QoL: Venous Leg Ulcer Quality of Life Instrument	Baseline, 4 weeks, 12 weeks
Other	Characterization of Disability measured using the VCSS	VCSS: Venous Clinical Severity Score	Baseline, 4 weeks, 12 weeks
Other	Characterization of Patient Satisfaction measured using a Patient Satisfaction Survey		Baseline, 4 weeks, 12 weeks
Other	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		12 weeks
Other	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		12 weeks
Other	Reasons for Cirvo(TM) discontinuation prior to complete healing (including, but not limited to: adverse events, self-withdrawal) will be tabulated		12 weeks
Primary	Percent of subjects fully healed at 12 weeks		12 weeks
Secondary	Percent of wound epithelialized at 12 weeks		12 weeks
Secondary	Percent of subjects fully healed at 4 weeks		4 weeks