Chronic Venous DiseasePhase 4NCT00766974
Compression Aided Management of Edema in Patients With C3 Venous Disease
A Phase 4 study testing Anti-embolism Knee High Stocking and 20-30 Knee High Compression Stocking in people with Chronic Venous Disease, run by BSN Medical Inc at 1 site in United States.
Trial summary
Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Venous Disease
- What is being tested?
- Anti-embolism Knee High Stocking and 20-30 Knee High Compression Stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with varicose veins exhibiting lower leg edema
- Unilateral or bi-lateral edema
Who cannot join
- Generalized leg edema from renal disease, heart failure, liver disease or other undetermined cause
- Acute infection
- Hepatitis
- Steroid use
- immuno-deficiencies including HIV
- Acute deep venous thrombosis
- Have had leg surgery or other orthopedic procedure in past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston VA Healthcare
West Roxbury, Massachusetts, 02132
Joseph Raffetto, MD, 857-203-5572, joseph.raffetto@med.va.gov
Kathleen Hickson, RN, 857-203-5572, kathleen.hickson@va.gov
About this study
Official title: Compression Versus Anti-Embolism Stockings in Patients With Leg Edema: Objective Investigation of Interface Compression and Edema Measurements, Clinical Outcomes, and Quality of Life.
Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.
Read the detailed description
Research Design: Pilot study of patients presenting to vascular clinic with chronic venous disease with varicose veins and/or edema will be randomized 1:1 in one of two compression garment groups. Measurements of edema and the interface compression applied at the ankle will be determined. The venous clinical severity scoring system and quality of life are assessed. After 4 weeks of treatment patients will have repeat objective studies and clinical outcomes determined.
Methodology: Patients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. Patients eligible for the study will be randomized to knee-high 20-30 Hg graded compression stockings or anti-embolism (13-18 mm Hg) compression stockings. Patients will have limb quantitative edema assessment, a severity score and quality of life determination. Compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. Following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. Data will be analyzed and presented as mean±sd. Data are analyzed using ANOVA followed by Scheffe's F test for comparison of multiple means. Student's t-test for unpaired and paired data will be used for comparison of two means. Differences are considered statistically significant if P < 0.05.
Significance: Utilizing objective measures of leg edema and applied interface pressure with two different compression garments, the data will provide the important relation between compression (mm Hg) and function of an appropriate graded compression stocking in improving limb edema and symptoms. In addition, measuring clinical outcomes before and after compression will validate the usefulness of proper compression. This study is intended to identify important quantifiable parameters that may be useful in assessing treatment end point including: clinical improvement, length of treatment, daily treatment utilization, prognosis, and clinical guidelines for compression in a specific clinical setting.
- Conditions
- Chronic Venous Disease
- Being tested
- Anti-embolism Knee High Stocking, 20-30 Knee High Compression Stocking
- Keywords
- Chronic Venous Disease, C3, Edema, Compression Garments, Compression Stockings, Bioimpedance
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-embolism Knee High StockingDevice
Also called Kendall TEDS
Anti-embolism Knee High Compression Stocking
20-30 Knee High Compression StockingDevice
Also called Jobst 20-30 mmHg Compression Stocking
20-30 mmHg Knee High COmpression Stocking
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anti-embolism Knee High compression stocking Receives: Device: Anti-embolism Knee High Stocking |
| 2 | Active comparator | 20-30mmHg Knee High Jobst Compression Stocking Receives: Device: 20-30 Knee High Compression Stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema reduction measured by bio-impedance
Measured: 4 weeks
Secondary outcomes (1)
Clinical Venous Severity Score Improvement in QOL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BSN Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph Raffetto, MD, Principal investigator, Boston VA Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766974
- Sponsor's protocol ID
- BSNCL-0003
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Versus Anti-Embolism Stockings in Patients With Leg Edema: Objective Investigation of Interface Compression and Edema Measurements, Clinical Outcomes, and Quality of Life.
- ClinicalTrials.gov ID
- NCT00766974
- Acronym / sponsor ID
- BSNCL-0003
- Conditions
- Chronic Venous Disease
- Keywords
- Chronic Venous Disease, C3, Edema, Compression Garments, Compression Stockings, Bioimpedance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BSN Medical IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Oct 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.
Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.
Detailed description
Research Design: Pilot study of patients presenting to vascular clinic with chronic venous disease with varicose veins and/or edema will be randomized 1:1 in one of two compression garment groups. Measurements of edema and the interface compression applied at the ankle will be determined. The venous clinical severity scoring system and quality of life are assessed. After 4 weeks of treatment patients will have repeat objective studies and clinical outcomes determined.
Methodology: Patients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. Patients eligible for the study will be randomized to knee-high 20-30 Hg graded compression stockings or anti-embolism (13-18 mm Hg) compression stockings. Patients will have limb quantitative edema assessment, a severity score and quality of life determination. Compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. Following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. Data will be analyzed and presented as mean±sd. Data are analyzed using ANOVA followed by Scheffe's F test for comparison of multiple means. Student's t-test for unpaired and paired data will be used for comparison of two means. Differences are considered statistically significant if P < 0.05.
Significance: Utilizing objective measures of leg edema and applied interface pressure with two different compression garments, the data will provide the important relation between compression (mm Hg) and function of an appropriate graded compression stocking in improving limb edema and symptoms. In addition, measuring clinical outcomes before and after compression will validate the usefulness of proper compression. This study is intended to identify important quantifiable parameters that may be useful in assessing treatment end point including: clinical improvement, length of treatment, daily treatment utilization, prognosis, and clinical guidelines for compression in a specific clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Anti-embolism Knee High StockingAnti-embolism Knee High compression stocking |
| 2 | Active comparator | Device: 20-30 Knee High Compression Stocking20-30mmHg Knee High Jobst Compression Stocking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with varicose veins exhibiting lower leg edema
- Unilateral or bi-lateral edema
Key exclusion criteria (7 listed)
- Generalized leg edema from renal disease, heart failure, liver disease or other undetermined cause
- Acute infection
- Hepatitis
- Steroid use
- immuno-deficiencies including HIV
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 |
|---|---|---|
| Anti-embolism Knee High StockingAlso: Kendall TEDSAnti-embolism Knee High Compression Stocking | Device | 1 |
| 20-30 Knee High Compression StockingAlso: Jobst 20-30 mmHg Compression Stocking20-30 mmHg Knee High COmpression Stocking | Device | 2 |
Primary outcome
Edema reduction measured by bio-impedance
Time frame: 4 weeks
1 secondary outcome
Clinical Venous Severity Score Improvement in QOL
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2008.
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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.
Joseph Raffetto, MD principal investigator
Boston VA Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-embolism Knee High Stocking and 20-30 Knee High Compression Stocking in people with Chronic Venous Disease, run by BSN Medical Inc 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema reduction measured by bio-impedance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2008.