Chronic Venous Insufficiency
Conditions
Keywords
chronic venous insufficiency, venous leg ulcers, pneumatic compression
Brief 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.
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.
Interventions
A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
DEVICEStandard Compression Garments
Compression stockings with a 30-40mmHg level of compression.
Sponsors
Tactile Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Standard Compression Garments Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. | 40 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 6 |
Baseline characteristics
| Characteristic | ACTitouch | Standard Compression Garments | Total |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 10.5 | 61.1 years STANDARD_DEVIATION 11.7 | 62.2 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 41 participants | 40 participants | 81 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 41 | 0 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
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.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very IPC 30 days | 62.3 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Donning - Baseline | 70.8 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very EasyDoffing - Baseline | 89.2 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very 1st Applied - Baseline | 70.8 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Donning - 30 Days | 64.9 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Doffing - 30 Day | 89.5 Percent of participants |
| ACTitouch | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very 1st Applied - 30 Days | 54.4 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very IPC 30 days | 0 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Donning - 30 Days | 54.8 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Donning - Baseline | 37.5 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very 1st Applied - 30 Days | 63.9 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very EasyDoffing - Baseline | 59.4 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Easy/Very Easy Doffing - 30 Day | 66.1 Percent of participants |
| Standard Compression Garments | Ease of Use and Comfort for Subjects Using the ACTitouch System. | % Reported Comfortable/Very 1st Applied - Baseline | 57.8 Percent of participants |