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The purpose of this study is to determine if complex lymphedema therapy is effective in decreasing disease severity and improving quality of life in patients with post thrombotic syndrome.
Post thrombotic syndrome (PTS) has a spectrum of disease manifestations ranging from minor skin discoloration to severe skin changes and venous ulcerations. Pain is often a prominent symptoms and PTS impairs patient quality of life. Prevention of PTS using compression stockings has been emphasized. There is a paucity of validated, effective treatments for PTS once the condition develops.
While the pathophysiology of PTS is incompletely understood, chronic venous hypertension and insufficiency may increase the workload of the lymphatic system and result in over-capacitance with secondary damage and eventual lymphatic insufficiency. In selected patients with PTS, we have noted a symptomatic improvement in patients who receive lymphedema therapy to the limb.
Complex lymphedema therapy (CLT) is a noninvasive treatment that includes four key components: meticulous skin care, manual lymph drainage, compression therapy, exercises and patient education for home management and continuation of the treatment. These techniques are designed to enhance lymph flow through intact cutaneous lymphatics and reduce swelling and restore function in the affected limb.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Complex lymphedema therapy (which includes compression stocking use) |
|
| B | Other | Standard of care (compression stocking use at 30-40 mm Hg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| complex lymphedema therapy | Other | Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome | 1 and 3 months | |
| To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome | 1 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess side effects of lymphedema therapy when administered to patients with PTS | 1 and 3 months | |
| To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome | 1 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris E Holmes, MD, PhD | University of Vermont and Fletcher Allen Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fletcher Allen Health Care; Department of Hematology/Oncology | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24558028 | Derived | Holmes CE, Bambace NM, Lewis P, Callas PW, Cushman M. Efficacy of a short course of complex lymphedema therapy or graduated compression stocking therapy in the treatment of post-thrombotic syndrome. Vasc Med. 2014 Feb;19(1):42-8. doi: 10.1177/1358863X14521883. |
| Label | URL |
|---|---|
| Dedicated to improving the human condition affected by cancer, through research in the laboratory and in the clinic, cancer prevention and control research and programs, state-of-the art cancer diagnosis. | View source |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| D004487 | Edema |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014648 | Varicose Veins |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |