Chronic Venous InsufficiencyNCT02015221

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

A study testing Dual Action Pneumatic Compression Device and Standard Compression Garments in people with Chronic Venous Insufficiency, run by Tactile Medical at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Venous Insufficiency
What is being tested?: Dual Action Pneumatic Compression Device and Standard Compression Garments
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 11 sitesUnited States
Study dates: Nov 2013to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University Hospitals Case Medical Center
Cleveland, Ohio, 44106-1261
Empire Orthopedic Center
Colton, California, 92324
Ohio Health System
Columbus, Ohio, 43214
Greenville Hospital System
Greenville, South Carolina, 29615
University of California, San Diego
La Jolla, California, 92093
VA Loma Linda Healthcare System
Loma Linda, California, 92357
Long Beach VA Healthcare System
Long Beach, California, 90822
Park Nicollet Heart and Vascular Center
Minneapolis, Minnesota, 55426
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, 85015
Stony Brook Vein Center
Stony Brook, New York, 11794-8191
Jobst Vascular Institute
Toledo, Ohio, 43606

Other trials in United States

About this study

Read the 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.

Conditions: Chronic Venous Insufficiency
Being tested: Dual Action Pneumatic Compression Device, Standard Compression Garments
Keywords: chronic venous insufficiency, venous leg ulcers, pneumatic compression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual Action Pneumatic Compression DeviceDevice
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 GarmentsDevice
Compression stockings with a 30-40mmHg level of compression.

Study groups in NCT02015221
Study group	Role	What they receive
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. Receives: Device: Dual Action Pneumatic Compression Device
Standard Compression Garments	Active comparator	Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. Receives: Device: Standard Compression Garments

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Aug 2015

First posted19 Dec 2013 (estimated)
Study startNov 2013
Primary completionJul 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02015221
Sponsor's protocol ID: ACTitouch EOU
Status last verified: Oct 2016
First submitted: 2 Dec 2013
Last updated: 15 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28818225

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
Recruiting
Pedal Pump Clinical Trial on Edema V2
Lower Extremity Edema, Lower Extremity Edema Chronic

All Chronic Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
ClinicalTrials.gov ID: NCT02015221
Acronym / sponsor ID: ACTitouch EOU
Conditions: Chronic Venous Insufficiency
Keywords: chronic venous insufficiency, venous leg ulcers, pneumatic compression
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Tactile MedicalIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jul 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 19 Dec 2013 (estimated)
Results: Posted 15 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACTitouch	Experimental	Device: Dual Action Pneumatic Compression DeviceACTitouch 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 GarmentsStandard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual Action Pneumatic Compression DeviceA novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.	Device	ACTitouch
Standard Compression GarmentsCompression stockings with a 30-40mmHg level of compression.	Device	Standard Compression Garments

Primary outcome

Ease of Use and Comfort for Subjects Using the ACTitouch System.
Time frame: 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.

Results and safety

Results posted to the registry on 15 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACTitouch	41	32
Standard Compression Garments	40	34

Primary outcome: Ease of Use and Comfort for Subjects Using the ACTitouch System.

Time frame: 30 days. Number (95% Confidence Interval). Unit: Percent of participants

Measure	ACTitouch n = 41	Standard Compression Garments n = 40
% Reported Easy/Very Easy Donning - Baseline	70.8 (58.8 to 80.4)	37.5 (26.7 to 49.7)
% Reported Easy/Very EasyDoffing - Baseline	89.2 (79.4 to 94.7)	59.4 (47.1 to 70.5)
% Reported Comfortable/Very 1st Applied - Baseline	70.8 (58.8 to 80.4)	57.8 (45.6 to 69.1)
% Reported Easy/Very Easy Donning - 30 Days	64.9 (51.9 to 76.0)	54.8 (42.5 to 66.6)
% Reported Easy/Very Easy Doffing - 30 Day	89.5 (78.9 to 95.1)	66.1 (53.7 to 76.7)
% Reported Comfortable/Very 1st Applied - 30 Days	54.4 (41.6 to 66.6)	63.9 (51.4 to 74.8)
% Reported Comfortable/Very IPC 30 days	62.3 (48.8 to 74.1)	0 (0 to 0)

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACTitouch	0 of 41 (0%)	5 of 41 (12.2%)	Not reported
Standard Compression Garments	0 of 40 (0%)	0 of 40 (0%)	Not reported

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28818225Lurie 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.

Related trials for Chronic Venous Insufficiency

Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
Recruiting
Pedal Pump Clinical Trial on Edema V2
Lower Extremity Edema, Lower Extremity Edema Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fedor Lurie, MD, PhD principal investigator

Associate Director, Jobst Vascular Institute

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dual Action Pneumatic Compression Device and Standard Compression Garments in people with Chronic Venous Insufficiency, run by Tactile Medical at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ease of Use and Comfort for Subjects Using the ACTitouch System. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02015221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.