NCT00766974

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

11 months

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Chronic Venous Disease

Keywords

Chronic Venous DiseaseC3EdemaCompression GarmentsCompression StockingsBioimpedance

Outcome Measures

Primary Outcomes (1)

  • Edema reduction measured by bio-impedance

    4 weeks

Secondary Outcomes (1)

  • Clinical Venous Severity Score Improvement in QOL

    4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Anti-embolism Knee High compression stocking

Device: Anti-embolism Knee High Stocking

2

ACTIVE COMPARATOR

20-30mmHg Knee High Jobst Compression Stocking

Device: 20-30 Knee High Compression Stocking

Interventions

Anti-embolism Knee High StockingDEVICE

Anti-embolism Knee High Compression Stocking

Also known as: Kendall TEDS
1
20-30 Knee High Compression StockingDEVICE

20-30 mmHg Knee High COmpression Stocking

Also known as: Jobst 20-30 mmHg Compression Stocking
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with varicose veins exhibiting lower leg edema
  • Unilateral or bi-lateral edema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston VA Healthcare

West Roxbury, Massachusetts, 02132, United States

RECRUITING

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Raffetto, MD

    Boston VA Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

US(1)