Recruiting

Compression

Sponsor:

BSN Medical Inc

Code:

NCT00766974

Conditions

Chronic Venous Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Anti-embolism Knee High Stocking

20-30 Knee High Compression Stocking

Study Details

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.

Conditions

Chronic Venous Disease

Study ID

NCT00766974

Start date

Oct, 2008

Status verified date

Oct, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Anti-embolism Knee High compression stocking

active comparator: 2

20-30mmHg Knee High Jobst Compression Stocking

Interventions

Anti-embolism Knee High Stocking

Anti-embolism Knee High Compression Stocking

20-30 Knee High Compression Stocking

20-30 mmHg Knee High COmpression Stocking

Primary outcome measure

  • Edema reduction measured by bio-impedance [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

Boston VA Healthcare

Recruiting

West Roxbury, Massachusetts, United States, 02132

Contacts

Joseph Raffetto, MD

857-203-5572joseph.raffetto@med.va.gov

Kathleen Hickson, RN

857-203-5572kathleen.hickson@va.gov

Principal Investigator:

Joseph Raffetto, MD

More Information

Sponsor

BSN Medical Inc

Last update posted

Oct 6, 2008

Last verified

Oct, 2008

Keywords

  • Chronic Venous Disease
  • C3
  • Edema
  • Compression Garments
  • Compression Stockings
  • Bioimpedance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BSN Medical Inc on 2008-10-06.