Venous Leg UlcerNCT02395302
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
A study testing Dual Action Pneumatic Compression in people with Venous Leg Ulcer and Chronic Venous Insufficiency, run by Tactile Medical at 6 sites in United States.
Trial summary
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer
- What is being tested?
- Dual Action Pneumatic Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2014to Nov 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
- Subject must be ≥ 18 years of age or legal age at the time of enrollment.
- Chronic venous insufficiency confirmed by ultrasound within previous 12 months.
- Active ulceration (CEAP classification of C6)
- Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with conservative treatment.
- Ulcer size ≥ 2cm2 ≤ 50cm2
- Leg circumferences within the following range:Ankle - 12 to 44cm;Calf - 22 to 60cm; Below knee - 22 to 68cm
Who cannot join
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Greater than 3 separate full thickness ulcers on the study limb
- Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
- Treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment.
- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 3 months.
- Either the dorsalis pedis (DP) or posterior tibial (PT) systolic pressure < 80mmHg for diabetic patients or < 60mmHg for non-diabetic patients on study limb or transcutaneous partial pressure oxygen (Tcp02) ≤ 30mmHg or great toe systolic pressure ≤ 40mmHg.
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- Acute thrombophlebitis.
- History of pulmonary edema or decompensated congestive heart failure.
- Currently has an active infection of the skin such as cellulitis requiring antibiotics.
- History of cancer within the last 5 years with the exception of treated non-melanoma skin cancer or cervical carcinoma in situ.
- Poorly controlled diabetes with a Hemoglobin A1c (HbA1c) value of >12%.
- Changes to medications that affect edema within the last 30 days
- Need for current and ongoing therapy with corticosteroids (exception for continued low dose usage) or cytotoxic drugs or the current use of Daflon 500.
- Currently pregnant or trying to become pregnant.
- Inability or unwillingness to participate in all aspects of study protocol.
- Currently participating in another clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Medical Center
Boston, Massachusetts, 02118
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
University of Miami School Hospital
Miami, Florida, 33125
St. Luke's Roosevelt Hospital Center
New York, New York, 10025
Center for Clinical Research
San Francisco, California, 94115
About this study
Official title: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort in Patients With Venous Leg Ulcers
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
Read the detailed description
Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Being tested
- Dual Action Pneumatic Compression
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Action Pneumatic CompressionDevice
Also called ACTitouch system
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Dual Action Pneumatic Compression | Experimental | Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Receives: Device: Dual Action Pneumatic Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device
A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below:
- The device was comfortable to wear during Sustained Compression Mode.
- The device was comfortable to wear during Intermittent Compression Mode.
- The noise from the device was not bothersome.
- The device was easy to put on.
- The device was easy to take off.
- The device was easy to use.
- The device was light-weight and portable.
- The use of the device helped my wound heal faster.
- I would use the device again on another wound in the future.
- Since using the device, my quality of sleep has improved.
- It was a burden to come to the wound care clinic for my dressing changes.
- The use of the device did not restrict many of my normal activities.
- The device was cumbersome and interfered with my mobility.
- I was able to work while being treated with the device.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionNov 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.
- Other trials for Venous Leg UlcerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Marston, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395302
- Sponsor's protocol ID
- 6020
- Status last verified
- Feb 2017
- First submitted
- 10 Mar 2015
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. 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 in Patients With Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02395302
- Acronym / sponsor ID
- 6020
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
Detailed description
Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual Action Pneumatic Compression | Experimental | Device: Dual Action Pneumatic CompressionDual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be ≥ 18 years of age or legal age at the time of enrollment.
- Chronic venous insufficiency confirmed by ultrasound within previous 12 months.
- Active ulceration (CEAP classification of C6)
- Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with conservative treatment.
- Ulcer size ≥ 2cm2 ≤ 50cm2
Key exclusion criteria (16 listed)
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Greater than 3 separate full thickness ulcers on the study limb
- Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
- Treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment.
- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 3 months.
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 CompressionAlso: ACTitouch systemWear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period. | Device | Dual Action Pneumatic Compression |
Primary outcome
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device
Time frame: 4 weeks
A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode. 2. The device was comfortable to wear during Intermittent Compression Mode. 3. The noise from the device was not bothersome. 4. The device was easy to put on. 5. The device was easy to take off. 6. The device was easy to use. 7. The device was light-weight and portable. 8. The use of the device helped my wound heal faster. 9. I would use the device again on another wound in the future. 10. Since using the device, my quality of sleep has improved. 11. It was a burden to come to the wound care clinic for my dressing changes. 12. The use of the device did not restrict many of my normal activities. 13. The device was cumbersome and interfered with my mobility. 14. I was able to work while being treated with the device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William Marston, MD principal investigator
University of North Carolina, Chapel Hill
6 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 in people with Venous Leg Ulcer and Chronic Venous Insufficiency, run by Tactile Medical at 6 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 6 inclusion and 16 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 23 Feb 2017). 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?
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.