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Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

Primary Purpose

Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual Action Pneumatic Compression
Sponsored by
Tactile Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Center for Clinical Research
  • University of Miami School Hospital
  • Tufts Medical Center
  • Boston Medical Center
  • Englewood Hospital and Medical Center
  • St. Luke's Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dual Action Pneumatic Compression

Arm Description

Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2015
Last Updated
February 23, 2017
Sponsor
Tactile Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02395302
Brief Title
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
Official Title
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort in Patients With Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Action Pneumatic Compression
Arm Type
Experimental
Arm Description
Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet.
Intervention Type
Device
Intervention Name(s)
Dual Action Pneumatic Compression
Other Intervention Name(s)
ACTitouch system
Intervention Description
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
Primary Outcome Measure Information:
Title
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Marston, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Miami School Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York City
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

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