Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

Chronic Venous Insufficiency Clinical Trial

Official title:

Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015221
• Other study ID #: ACTitouch EOU
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: June 2, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.

Description:

Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of unilateral or bilateral CVI with or without leg ulcers

• Documented history of low adherence to compression garment therapy

• CEAP classification C3-C6

• Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm

Exclusion Criteria:

• History of skin sensitivity to any of the components of ACTitouch or compression garments

• History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months

• Ankle Brachial Index (ABI) < 0.8

• Acute thrombophlebitis

• History of pulmonary edema or decompensated congestive heart failure

• Currently has an active infection of the skin such as cellulitis requiring antibiotics

• Poorly controlled diabetes with an HbA1c value of >10%

• Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.

• Subjects with open ulcers must be le to follow their care regimen for ulcer healing concurrently with the assigned study regimen.

• Participating in another clinical trial

• Changes to medications that affect edema within the last 30 days

• Currently pregnant or trying to become pregnant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Device:
• Dual Action Pneumatic Compression Device
A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
• Standard Compression Garments
Compression stockings with a 30-40mmHg level of compression.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Empire Orthopedic Center	Colton	California
United States	Ohio Health System	Columbus	Ohio
United States	Greenville Hospital System	Greenville	South Carolina
United States	University of California, San Diego	La Jolla	California
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Long Beach VA Healthcare System	Long Beach	California
United States	Park Nicollet Heart and Vascular Center	Minneapolis	Minnesota
United States	Associated Foot and Ankle Specialists, LLC	Phoenix	Arizona
United States	Stony Brook Vein Center	Stony Brook	New York
United States	Jobst Vascular Institute	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of use and comfort for subjects using the ACTitouch system.	Questionnaire, analysis	30 days	No