Chronic Venous Insufficiency, Venous Insufficiency, Venous Leg Ulcer, Venous Stasis Ulcer, Venous Ulcer
Conditions
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.
Interventions
DEVICEDual Action Pneumatic Compression
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
Sponsors
Tactile Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Run In Failure | 7 |
| Overall Study | Screen Failure | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Dual Action Pneumatic Compression |
|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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: 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.
Time frame: 4 weeks
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 1 | 12 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 2 | 8 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 3 | 9 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 4 | 15 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 5 | 15 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 6 | 15 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 7 | 11 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 8 | 8 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 9 | 13 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 10 | 7 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 11 | 6 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 12 | 9 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 13 | 9 Participants |
| Dual Action Pneumatic Compression | Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device | Participants who agreed with Question 14 | 8 Participants |