A non-interventional study of mediven®- compression stockings on the question of product safety and compliance in patients with phlebological disease in outpatient care according to §23b MPG (German Medical Devices Act)

• Conditions: I80.0; I80.1; I80.2; I80.8; I82.1; I82.2; I83.0; I83.1; I83.2; I83.9

• Registration Number: DRKS00006124
• Lead Sponsor: medi GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-05-28
• Study Start: 2014-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 841

Inclusion Criteria

1) Age between 18 and 79 years
2) CVI stage C1/S – C6 (CEAP)
3) Phlebological indications according to ICD 10
4) No phlebological care with compression treatment has been given in the past 6 weeks
5) 6 weeks has elapsed since a varicosis-eliminating measure on the saphenous veins with 6 weeks of aftercare with MCS (renewed diagnosis of an indication for MCS)
6) Indication for longer-term (= 18 months) care with round knit MCG is given
7) No contraindication for MCS
8) Sufficient mental and physical skills and preconditions for participation in the study
9) Written declaration of consent is available

Exclusion Criteria

1) Foreseeable life expectancy less than 2 years
2) Foreseeable need for intervention on the saphenous veins in the coming 18 months
3) Contraindications for MCS
4) Lack of sufficient mental and physical skills and preconditions for participation in the study
5) Need for care with flat knit MCS
6) Lack of phlebological indications for treatment
7) Primary lymphoedema; secondary lymphoedema that is not phlebologically-related;
marked lipoedema
8) No declaration of consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Gain in knowledge on product safety and tolerability <br><br>b) Identification of undesirable effects <br><br>c) Documentation of the true picture of care provided to phlebological patients in an outpatient setting<br>

Secondary Outcome Measures

Name	Time	Method
a) Gain in knowledge on factors that may influence patient compliance <br><br>b) Determination of the rate of discontinuation and determination of the major aspects that lead patients to discontinue treatment <br><br>c) Quality of life<br>