Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTitouch | Experimental | 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 | Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use and Comfort for Subjects Using the ACTitouch System. | Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied. | 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fedor Lurie, MD, PhD | Associate Director, Jobst Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Foot and Ankle Specialists, LLC | Phoenix | Arizona | 85015 | United States | ||
| Empire Orthopedic Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28818225 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ACTitouch | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Compression Garments | Device | Compression stockings with a 30-40mmHg level of compression. |
|
| Colton |
| California |
| 92324 |
| United States |
| University of California, San Diego | La Jolla | California | 92093 | United States |
| VA Loma Linda Healthcare System | Loma Linda | California | 92357 | United States |
| Long Beach VA Healthcare System | Long Beach | California | 90822 | United States |
| Park Nicollet Heart and Vascular Center | Minneapolis | Minnesota | 55426 | United States |
| Stony Brook Vein Center | Stony Brook | New York | 11794-8191 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106-1261 | United States |
| Ohio Health System | Columbus | Ohio | 43214 | United States |
| Jobst Vascular Institute | Toledo | Ohio | 43606 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29615 | United States |
| FG001 | Standard Compression Garments | Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants with bilateral disease received both treatment. The participate was randomly assigned a treatment to the right leg and were instructed to wear the other treatment on their left leg.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACTitouch | 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. |
| BG001 | Standard Compression Garments | Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ease of Use and Comfort for Subjects Using the ACTitouch System. | Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied. | Posted | Number | 95% Confidence Interval | Percent of participants | 30 days | Lower Extremities Analyzed | Participants |
|
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTitouch | 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. 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. | 0 | 41 | 5 | 41 | ||
| EG001 | Standard Compression Garments | Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression. | 0 | 40 | 0 | 40 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcer / Blister | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Swelling | Vascular disorders | Non-systematic Assessment |
|
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).
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Tactile Medical | 6123555121 | shoy@tactilemedical.com |
| Male |
|
| % Reported Comfortable/Very 1st Applied - Baseline |
|
| % Reported Easy/Very Easy Donning - 30 Days |
|
| % Reported Easy/Very Easy Doffing - 30 Day |
|
| % Reported Comfortable/Very 1st Applied - 30 Days |
|
| % Reported Comfortable/Very IPC 30 days |
|