Chronic Venous Insufficiency Clinical Trial
Official title:
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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 |
Lead Sponsor | Collaborator |
---|---|
Tactile Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ease of use and comfort for subjects using the ACTitouch system. | Questionnaire, analysis | 30 days | No |
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