Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dual Action Pneumatic Compression Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. |
Device: Dual Action Pneumatic Compression
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device [4 weeks]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Clinical Research | San Francisco | California | United States | 94115 |
| 2 | University of Miami School Hospital | Miami | Florida | United States | 33125 |
| 3 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 4 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 5 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 6 | St. Luke's Roosevelt Hospital Center | New York City | New York | United States | 10025 |
Sponsors and Collaborators
- Tactile Medical
Investigators
- Principal Investigator: William Marston, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dual Action Pneumatic Compression |
|---|---|
| Arm/Group 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. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period. |
| Period Title: Overall Study | |
| STARTED | 28 |
| COMPLETED | 14 |
| NOT COMPLETED | 14 |
Baseline Characteristics
| Arm/Group Title | Dual Action Pneumatic Compression |
|---|---|
| Arm/Group Description | Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet. Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period. |
| Overall Participants | 27 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
61.9
(13.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
14
51.9%
|
| Male |
13
48.1%
|
| Region of Enrollment (participants) [Number] | |
| United States |
27
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Tolerance and Comfort questionnaire was completed at study exit by 16 participants (13 of the 16 total subjects completed the study, 2 were withdrawn by their site's Investigator, and 1 voluntarily withdrew). Six participants were not employed during the time of questionnaire completion. Question 14 was not applicable to these participants. |
| Arm/Group Title | Dual Action Pneumatic Compression |
|---|---|
| Arm/Group Description | Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet. |
| Measure Participants | 16 |
| Participants who agreed with Question 1 |
12
44.4%
|
| Participants who agreed with Question 2 |
8
29.6%
|
| Participants who agreed with Question 3 |
9
33.3%
|
| Participants who agreed with Question 4 |
15
55.6%
|
| Participants who agreed with Question 5 |
15
55.6%
|
| Participants who agreed with Question 6 |
15
55.6%
|
| Participants who agreed with Question 7 |
11
40.7%
|
| Participants who agreed with Question 8 |
8
29.6%
|
| Participants who agreed with Question 9 |
13
48.1%
|
| Participants who agreed with Question 10 |
7
25.9%
|
| Participants who agreed with Question 11 |
6
22.2%
|
| Participants who agreed with Question 12 |
9
33.3%
|
| Participants who agreed with Question 13 |
9
33.3%
|
| Participants who agreed with Question 14 |
8
29.6%
|
Adverse Events
| Time Frame | 6 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Dual Action Pneumatic Compression | |
| Arm/Group Description | Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet. | |
All Cause Mortality |
||
| Dual Action Pneumatic Compression | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Dual Action Pneumatic Compression | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Dual Action Pneumatic Compression | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/28 (35.7%) | |
| General disorders | ||
| Migraine | 1/28 (3.6%) | 2 |
| Infections and infestations | ||
| Wound infection | 1/28 (3.6%) | 1 |
| Conjunctivitis infective | 1/28 (3.6%) | 1 |
| Injury, poisoning and procedural complications | ||
| Pain in extremity | 3/28 (10.7%) | 4 |
| Skin ulcer | 1/28 (3.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Cramping | 1/28 (3.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Blister | 3/28 (10.7%) | 3 |
| Application site erythema | 1/28 (3.6%) | 1 |
| Rash | 1/28 (3.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Research Manager |
|---|---|
| Organization | Tactile Medical |
| Phone | (612)355-5123 |
| mbroich@tactilemedical.com |
- 6020