Elastic Compression in Chronic Venous Disease (RECVEN)

U

University of Patras

Status

Unknown

Conditions

Varicosity

Treatments

Device: Elastic stockings
Device: Placebo stockings

Study type

Interventional

Funder types

Other

Identifiers

NCT02641600
35/18.02.2015

Details and patient eligibility

About

Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings

Full description

Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary varicose veins causing pain/ache located only at the calf level

Exclusion criteria

  • Venous ulceration
  • Dermatitis
  • Itching
  • Superficial vein thrombosis
  • Peripheral arterial disease
  • Symptoms of non-venous origin
  • Previous use of elastic stockings

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Elastic stockings
Active Comparator group
Description:
Class 1 elastic stockings (18-21 mmHg)
Treatment:
Device: Elastic stockings
Placebo stockings
Placebo Comparator group
Description:
Placebo stockings (0 mmHg)
Treatment:
Device: Placebo stockings

Trial contacts and locations

1

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Central trial contact

Stavros K Kakkos, MD, PhD, RVT

Data sourced from clinicaltrials.gov

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