Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Vermont |
---|---|
Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00633971 |
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.
Condition | Intervention | Phase |
---|---|---|
Post Thrombotic Syndrome |
Other: complex lymphedema therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome |
Estimated Enrollment: | 44 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Complex lymphedema therapy (which includes compression stocking use)
|
Other: complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
|
B
Standard of care (compression stocking use at 30-40 mm Hg)
|
Other: complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chris E Holmes, MD, PhD | 802-847-8400 | chris.holmes@uvm.edu |
Contact: Karen Gilder, RN | karen.gilder@vtmednet.org |
United States, Vermont | |
Fletcher Allen Health Care; Department of Hematology/Oncology | Recruiting |
Burlington, Vermont, United States, 05401 | |
Contact: Chris E Holmes, MD, PhD 802-847-8400 chris.holmes@uvm.edu |
Principal Investigator: | Chris E Holmes, MD, PhD | University of Vermont and Fletcher Allen Health Care |
Responsible Party: | University of Vermont- Fletcher Allen Health Care ( Chris E. Holmes, M.D., Ph.D. Assistant Professor, Department of Medicine ) |
Study ID Numbers: | CHRMS 08-065 |
Study First Received: | March 4, 2008 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00633971 History of Changes |
Health Authority: | United States: Institutional Review Board |
Post thrombotic syndrome Thrombosis Deep vein thrombosis |
Venous thrombosis Edema stasis ulcers |
Peripheral Vascular Diseases Ulcer Vascular Diseases Quality of Life Edema Postthrombotic Syndrome Thrombosis |
Lymphedema Embolism and Thrombosis Embolism Venous Insufficiency Phlebitis Venous Thrombosis Postphlebitic Syndrome |
Peripheral Vascular Diseases Disease Vascular Diseases Postthrombotic Syndrome Thrombosis Embolism and Thrombosis Pathologic Processes |
Syndrome Venous Insufficiency Phlebitis Venous Thrombosis Cardiovascular Diseases Postphlebitic Syndrome |