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| Name | Class |
|---|---|
| Tactile Medical | INDUSTRY |
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This study seeks to demonstrate the effect of advanced pneumatic compression in treatment naïve patients with CEAP C3 and C4 chronic venous disease. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Subjects will receive standard-of-care compression bandaging. |
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| Treatment Arm | Experimental | Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green near infrared fluorescence imaging | Combination Product | A total of 10 intradermal injections of 25 ug indocyanine green (ICG) in 0.1 mL saline are administered in the feet, medial ankles, lateral calves, and thigh. The total dose of ICG will not exceed 250 ug. After injection, the legs will be illuminated by the dim output of a 780 nm laser diode, and the resultant fluorescent signal emanating from ICG-laden lymph will be collected by a custom built near-infrared fluorescent lymphatic imager. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Dermal Backflow | The area of abnormal dermal lymphatic backflow in the leg. | Assessed at Visit 1 and 2 (approximately 30 days apart) |
| Lymphatic pumping rate | Number of pumping events observed per minute assessed in the medial ankle. | Assessed at Visit 1 and Visit 2 (approximately 30 days apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of CEAP score and lymphatic pumping rates | Assessed at Visit 1 and 2 (approximately 30 days apart) | |
| Correlation of CEAP score with extent of dermal backflow | Assessed at Visit 1 and 2 (approximately 30 days apart) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Rasmussen, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston/UTPhysicians | Houston | Texas | 77030 | United States |
Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images that may include protected health information (tattoos). Partial, redacted data sets may be sharable upon request.
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This is a blinded, prospective, 2-arm, randomized study.
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| advanced pneumatic compression | Device | The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy. Daily treatment will be prescribed for approximately 30 days. |
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| Duplex ultrasound | Diagnostic Test | Duplex ultrasound to measure venous reflux will be done at each visit. |
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| compression wrap | Device | A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days). |
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| Change in limb volume between arms. | Limb volume, determined from limb circumference measurements, will be assessed at both visits. | Assessed at Visit 1 and 2 (approximately 30 days apart) |
| Change in LLIS score between arms | Patient reported outcomes assessed using the Lymphedema Life Impact Scale (LLIS) at each visit and change determined after Visit 2. Possible scores range from 0 to 100 with a higher score indicating a greater impact of disease on quality of life. | Assessed at Visit 1 and 2 (approximately 30 days apart) |
| Change in Venous Clinical Severity Score (VCSS) between arms | Venous Clinical Severity Score (VCSS) will be assessed at each visit. Possible scores range from 0 to 30 with a higher score indicating a greater severity of vascular disease. | Assessed at Visit 1 and 2 (approximately 30 days apart) |
| Change in patient reported outcomes between arms | Patient reported outcomes assessed using the Lower Extremity Functional Scale (LEFS) at each visit and change determined after Visit 2. Possible scores range from 0 to 80 with a higher score indicating a greater impact of disease on limb functionality. | Assessed at Visit 1 and 2 (approximately 30 days apart) |
| ID | Term |
|---|---|
| D018616 | Ultrasonography, Doppler, Duplex |
| D058128 | Compression Bandages |
| ID | Term |
|---|---|
| D018608 | Ultrasonography, Doppler |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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