I87.20
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Mean values of the respective weeks 1 - 5. | — |
Countries
Germany
Contacts
Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken, Ruhr-Universität Bochum