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

NCT02015221 — Not applicable, Completed, 81 participants, Tactile Medical

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Registry	NCT02015221
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none
Enrollment	81 (Actual)
Sponsor	Tactile Medical (Industry)
Conditions	Chronic Venous Insufficiency
Interventions	Dual Action Pneumatic Compression Device, Standard Compression Garments (Device)
Dates	start 2013-11-01, primary completion 2015-07-01, completion 2015-08-01, first posted 2013-12-19, last updated 2016-12-15
Locations	11 sites in United States

-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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
ACTitouch	Experimental	Device: Dual Action Pneumatic Compression Device	ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Standard Compression Garments	Active comparator	Device: Standard Compression Garments	Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.

Dual Action Pneumatic Compression Device (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 (Device): Compression stockings with a 30-40mmHg level of compression.

+Outcome measures

Primary outcomes

Ease of Use and Comfort for Subjects Using the ACTitouch System. [30 days]: Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.

+Eligibility

Sex: All, ages: 18 Years to any

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 able 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

+Posted results

Participant flow

Milestone	ACTitouch	Standard Compression Garments
Started	41	40
Completed	32	34
Not completed	9	6

Outcome results

Ease of Use and Comfort for Subjects Using the ACTitouch System. (Primary), Number, Percent of participants: ACTitouch 70.8 (58.8 to 80.4); Standard Compression Garments 37.5 (26.7 to 49.7)

Adverse events

Time frame: 30 days

Arm	Deaths	Serious adverse events	Other adverse events
ACTitouch	0	0/41 (0.0%)	5/41 (12.2%)
Standard Compression Garments	0	0/40 (0.0%)	0/40 (0.0%)

Other adverse events by term

Term	Organ system	ACTitouch	Standard Compression Garments
Ulcer / Blister	Injury, poisoning and procedural complications	3/41	0/40
Rash	Skin and subcutaneous tissue disorders	1/41	0/40
Swelling	Vascular disorders	1/41	0/40

Limitations and caveats: Participants could have either unilateral or bilateral disease. Bilateral participants had treatment randomly assigned to the right leg. The left leg received the treatment not assigned to their right leg (i.e: right leg - Grp A: Left Leg - Grp B).

+Locations (11)

Facility	City	Country
Associated Foot and Ankle Specialists, LLC	Phoenix, Arizona	United States
Empire Orthopedic Center	Colton, California	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
Stony Brook Vein Center	Stony Brook, New York	United States
University Hospitals Case Medical Center	Cleveland, Ohio	United States
Ohio Health System	Columbus, Ohio	United States
Jobst Vascular Institute	Toledo, Ohio	United States
Greenville Hospital System	Greenville, South Carolina	United States

+Publications

Results publication: Lurie F, Schwartz M. Patient-centered outcomes of a dual action pneumatic compression device in comparison to compression stockings for patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):699-706.e1. doi: 10.1016/j.jvsv.2017.06.003. PMID 28818225

+Investigators

Fedor Lurie, MD, PhD, Principal investigator, Associate Director, Jobst Vascular Institute