N/A N=81 Randomized

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

Chronic Venous Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT02015221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Ease of Use and Comfort for Subjects Using the ACTitouch System. — 70.8; 37.5; 89.2; 59.4 Percent of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dual Action Pneumatic Compression Device (Device); Standard Compression Garments (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tactile Medical
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Ease of Use and Comfort for Subjects Using the ACTitouch System.	70.8; 37.5; 89.2; 59.4; 70.8; 57.8	—

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.

Eligibility Criteria

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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02015221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.