Randomized study to reduce symptoms of uncomplicated varicosis using Class I medical compression stockings

Not Applicable

• Conditions: I87.20

• Registration Number: DRKS00014743
• Lead Sponsor: St. Josef- und St. Elisabeth Hospital gGmbH, St. Josef- Hospital Klink für Dermatologie, Venerologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-14
• Study Completion: 2022-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age from 18 - 75 years
Duplex sonographic insufficiency of saphenous veins and/or deep veins
Detection of functionally relevant venous insufficiency using DPPG (reduced venous replenishment time)
symptoms (heaviness, pain, swelling, throbbing and itching)
Initial complaint score of at least 5 points
Ability and possibility to use the electronic diary (smartphone app) to record the complaint score.
Doppler sonographically determined ABI > 0.5 or systol. absolute pressure > 60mmHg
BMI = 35 kg/m2

Exclusion Criteria

Acute deep or superficial leg vein thrombosis
inability or unwillingness to put on or wear compression stockings
Absolute contraindications of compression therapy
Significantly reduced mobility (e.g. walking on crutches, walkers, wheelchairs)
Surgical or interventional measures on the veins in the last 6 weeks
Series supply with the study product not possible (e.g. calibre jumps in the leg shape)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survey of a symptom score using an electronic questionnaire<br><br>Method of complaint score:<br>The patients answer the following question daily between 17 and 22h: <br>How many times since you got up this morning have you noticed the following symptoms on your leg? heaviness, pain, swelling, throbbing and itching.<br><br>The answer options for each question with the corresponding score are as follows:<br>At no time: Score 0<br>Rarely: Score 1<br>Some time: Score 2<br>Over a long period: Score 3<br>Most of the time: Score 4<br>All the time: Score 5<br><br>Score values minimum 0, maximum 25 points<br>The leg with the most complaints should be evaluated. <br>At the same time, the wearing time of foot and mouth disease per day is recorded. <br><br>The primary endpoint is the score value determined daily over a period of 5 weeks. <br>

Secondary Outcome Measures

Name	Time	Method
Mean values of the respective weeks 1 - 5.