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)

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) - mediven-RS/2011

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006124

Enrollment

846

Registered

2014-06-30

Start date

2011-11-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I80.0 I80.1 I80.2 I80.8 I82.1 I82.2 I83.0 I83.1 I83.2 I83.9 I87.0 I87.1 I87.2 I87.9

Interventions

Group 1: During the observation period (18 months), a total of 5 visits (doctor's consultations) will take place, during which doctors will use their own discretion to perform physical and diagnostic

the study-related observation period will come to an end after 18 months.

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
a) Gain in knowledge on product safety and tolerability b) Identification of undesirable effects c) Documentation of the true picture of care provided to phlebological patients in an outpatient setting	—

Secondary

Measure	Time frame
a) Gain in knowledge on factors that may influence patient compliance b) Determination of the rate of discontinuation and determination of the major aspects that lead patients to discontinue treatment c) Quality of life	—

Countries

Germany

Contacts

Public ContactSandra Hahn

CYCLOMED GmbH medical services & consulting

info@cyclomed.de061 92 – 975 97 20

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026