Clinical trial NCT00633971: Treatment Trial for Post-Thrombotic Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Thrombotic Syndrome
Keywords: Post thrombotic syndrome
Thrombosis
Deep vein thrombosis
Venous thrombosis
Edema
stasis ulcers
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Diagnosis of post thrombotic syndrome.
* Median life expectancy of greater than 2 years.
* Previous history of lower extremity deep venous thrombosis.

Exclusion Criteria:

* Acute venous thrombosis of the lower extremity within the last 180 days.
* Unable to participate in lymphedema therapy due to monetary, physical or transportation limitations.
* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and women in their first post-partum month.

Primary outcomes:
measure: To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
timeFrame: 1 and 3 months
measure: To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome
timeFrame: 1 and 3 months
Secondary outcomes:
measure: To assess side effects of lymphedema therapy when administered to patients with PTS
timeFrame: 1 and 3 months
measure: To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome
timeFrame: 1 and 3 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Fletcher Allen Health Care; Department of Hematology/Oncology
state: Vermont
Study officials:
affiliation: University of Vermont and Fletcher Allen Health Care
name: Chris E Holmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.