Post Thrombotic SyndromeNCT00633971
Treatment Trial for Post-Thrombotic Syndrome
A study testing complex lymphedema therapy in people with Post Thrombotic Syndrome, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thrombotic Syndrome
- What is being tested?
- complex lymphedema therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Diagnosis of post thrombotic syndrome.
- Median life expectancy of greater than 2 years.
- Previous history of lower extremity deep venous thrombosis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care; Department of Hematology/Oncology
Burlington, Vermont, 05401
About this 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
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.
Read the 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.
- Conditions
- Post Thrombotic Syndrome
- Being tested
- complex lymphedema therapy
- Keywords
- Post thrombotic syndrome, Thrombosis, Deep vein thrombosis, Venous thrombosis, Edema, stasis ulcers
- Medical subject headings
- Postthrombotic Syndrome, Thrombosis, Venous Thrombosis, Edema, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complex lymphedema therapyOther
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Complex lymphedema therapy (which includes compression stocking use) Receives: Other: complex lymphedema therapy |
| B | Other | Standard of care (compression stocking use at 30-40 mm Hg) Receives: Other: complex lymphedema therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
Measured: 1 and 3 months
To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome
Measured: 1 and 3 months
Secondary outcomes (2)
To assess side effects of lymphedema therapy when administered to patients with PTS
Measured: 1 and 3 months
To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Holmes, University of Vermont
- Investigators
- Chris E Holmes, MD, PhD, Principal investigator, University of Vermont and Fletcher Allen Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633971
- Sponsor's protocol ID
- CHRMS 08-065
- Status last verified
- Sep 2020
- First submitted
- 4 Mar 2008
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24558028
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00633971
- Acronym / sponsor ID
- CHRMS 08-065
- Conditions
- Post Thrombotic Syndrome
- Keywords
- Post thrombotic syndrome, Thrombosis, Deep vein thrombosis, Venous thrombosis, Edema, stasis ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: complex lymphedema therapyComplex lymphedema therapy (which includes compression stocking use) |
| B | Other | Other: complex lymphedema therapyStandard of care (compression stocking use at 30-40 mm Hg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years.
- Diagnosis of post thrombotic syndrome.
- Median life expectancy of greater than 2 years.
- Previous history of lower extremity deep venous thrombosis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complex lymphedema therapyPatients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy. | Other | A, B |
Primary outcome
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
Time frame: 1 and 3 months
To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome
Time frame: 1 and 3 months
2 secondary outcomes
To assess side effects of lymphedema therapy when administered to patients with PTS
Time frame: 1 and 3 months
To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome
Time frame: 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Derived from this study: PubMed 24558028Holmes 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris E Holmes, MD, PhD principal investigator
University of Vermont and Fletcher Allen Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complex lymphedema therapy in people with Post Thrombotic Syndrome, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome (time frame: 1 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.