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

Randomized study to reduce symptoms of uncomplicated varicosis using Class I medical compression stockings - EUROCOM KKL 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014743
Enrollment
154
Registered
2018-05-14
Start date
2018-11-15
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

I87.20

Interventions

Group 1: Half of the patients (treatment arm 1) receive medical compression stockings for the weeks 2- 5. The stockings should be worn daily for at least 8 hours per day. The type of medical compress

Sponsors

St. Josef- und St. Elisabeth Hospital gGmbH, St. Josef- Hospital Klink für Dermatologie, Venerologie und Allergologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Mean values of the respective weeks 1 - 5.

Countries

Germany

Contacts

Public ContactMaren Hoffmann

Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken, Ruhr-Universität Bochum

m.stuecker@klinikum-bochum.de+49 234 8792- 274

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026