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

Optimisation of intermittent pneumatic compression in patients with oedema of the legs of different etiologies - IPC+ trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029941
Enrollment
18
Registered
2022-08-04
Start date
2019-08-29
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

I89.0 I87.2

Interventions

Group 1: Patients with leg oedema of various etiologies are given decongestive therapy by means of manual and apparatus lymph drainage, compression bandages, exercise therapy. A volume reduction of th

Sponsors

Bauerfeind AG - Phlebology Business Development & Medical Affairs
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Volume reduction of the lower extremity in ml during decongestive therapy measured by means of 3D-assisted volume reduction of the legs, using BT600. The volume of the legs is checked daily under decongestive measures.

Secondary

MeasureTime frame
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).

Countries

Germany

Contacts

Public ContactMichael Jünger

Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald

juenger@uni-greifswald.de03834/866770

Outcome results

None listed

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