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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Action Pneumatic Compression | Device | Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Marston, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | San Francisco | California | 94115 | United States | ||
| University of Miami School Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Miami |
| Florida |
| 33125 |
| United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| St. Luke's Roosevelt Hospital Center | New York | New York | 10025 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Demographic information for 27 of the 28 study subjects was collected. One study subject was withdrawn from the study before demographic information was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual Action Pneumatic Compression | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | Posted | Count of Participants | Participants | 4 weeks |
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6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dual Action Pneumatic Compression | Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet. | 0 | 28 | 10 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Migraine | General disorders | Non-systematic Assessment |
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| Skin ulcer | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Wound infection | Infections and infestations | Non-systematic Assessment |
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| Application site erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Conjunctivitis infective | Infections and infestations | Non-systematic Assessment |
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| Cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Tactile Medical | (612)355-5123 | mbroich@tactilemedical.com |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Participants who agreed with Question 3 |
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| Participants who agreed with Question 4 |
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| Participants who agreed with Question 5 |
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| Participants who agreed with Question 6 |
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| Participants who agreed with Question 7 |
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| Participants who agreed with Question 8 |
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| Participants who agreed with Question 9 |
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| Participants who agreed with Question 10 |
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| Participants who agreed with Question 11 |
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| Participants who agreed with Question 12 |
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| Participants who agreed with Question 13 |
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| Participants who agreed with Question 14 |
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