Prospective, controlled trial on safety and efficacy of compression stockings for patients with CVI and pAVK (Angioflow2)

Not Applicable

• Conditions: I73.9; I87.2; I70.2; Peripheral vascular disease, unspecified; Venous insufficiency (chronic)(peripheral); Atherosclerosis of arteries of extremities

• Registration Number: DRKS00013978
• Lead Sponsor: St. Josef und St. Elisabeth Hospital gGmbHKlinik für Dermatologie, Venerologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-09
• Study Completion: 2018-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Age > 18 years old
- Chronic venous insufficiency of any genesis (varicose disease, PTS, arthrogenic congestion syndrome, dependency syndrome in obesity) in stages C3 to C5.
- ability to put on compression stockings or willingness to have them worn by third parties
- Written consent form
- Willingness to wear compression stockings of at least 8 hours per day during the study period
- Peripheral arterial occlusive disease with an ankle arm index <0.9 and >0.5 and an absolute ankle arterial pressure >60mmHg

Exclusion Criteria

- Pregnant or nursing patient
- Patient participating in another treatment study Patients with severe general illness for whom there is a risk of withdrawal before the end of the study.
- Patient with progressive malignant disease, associated with radiation therapy, Chemotherapy or hormone therapy treated.
- allergy to components of the compression stocking
- Absolute contraindication for an compression therapy: decompensated Heart failure, septic phlebitis, Phlegmasia coerulea dolens.
- Acute deep or superficial leg vein thrombosis
- disability or reluctance, put on compression stockings or to be worn florides Ulcus cruris, C6

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complaint score measured by the Varicose Vein Symptom Questionnaire <br>Acral pressure measured by means of acral oscillography

Secondary Outcome Measures

Name	Time	Method
- Leg volume, measured by Bodytronic 600®.<br>- Semiquantitative assessment of leg edema by ultrasound<br>- Visual analogue scale for pain (0=no pain, 10=strongest pain)<br>- Visual analogue scale for ease of use (pull stocking over the foot,<br> Suspender stocking overall, stocking take off)<br>- Wearing comfort of the compression stocking, measured as patient satisfaction<br> on a visual analogue scale.<br>- Anamnestic painless walking distance