Optimisation of intermittent pneumatic compression in patients with oedema of the legs of different etiologies

• Conditions: I89.0; I87.2; Lymphoedema, not elsewhere classified; Venous insufficiency (chronic)(peripheral)

• Registration Number: DRKS00029941
• Lead Sponsor: Bauerfeind AG - Phlebology Business Development & Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-09-28
• Study Start: 2022-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Oedema of the legs: primary and secondary lymphoedema, phleboedema, lipoedema.

Willingness and ability of the patient to apply intermittent pneumatic compression and to wear multi-layer compression bandages, and to follow the instructions of the doctor and the staff

Age between = 18 years

Presentation of the written declaration of consent to participate in the observational study after detailed information about the nature, significance, risks and scope of the observational study as well as about the expected desired and undesired effects of the treatment in the context of the observational study.

Sufficient written and spoken German language skills

Exclusion Criteria

Acute deep venous thrombosis and acute thrombophlebitis
Peripheral arterial occlusive disease stage III and IV according to Fontaine
Decompensated heart failure and severe, non-adjustable arterial hypertension (diastolic > 100 mmHg)
Acute tissue trauma, acute erysipelas (with systemic signs such as fever, reduced general condition, signs of sepsis)
Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume reduction of the lower extremity in ml during decongestive therapy measured by means of 3D-assisted volume reduction of the legs, using BT600. <br>The volume of the legs is checked daily under decongestive measures.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life under decongestive therapy measured by means of DLQI (dermatological quality of life index) and TLQ-CVI (Tübingen quality of life questionnaire). Quality of life is assessed at the time before decongestion, after decongestion and during the maintenance phase on the three days of follow-up (after one week, three weeks and six weeks).