Chronic venous insufficiency (CVI), deep vein thrombosis, lymphedema Circulatory System
Conditions
Interventions
Intervention: Lundatex® stocking – knee-high compression stocking Class 2 (23-32 mmHg). The stocking is used during the daytime for 2 weeks.
Control: Actico® UlcerSys – knee-high com
Sponsors
PressCise (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Venous insufficiency of the lower leg and classified as C3-C6 according to the Clinical-Aetiology-Anatomic-Pathophysiologic (CEAP) system or lymphedema 2. Leg circumference between 20 cm and 65 cm at the narrowest and widest places 3. Can tolerate compression therapy 4. Ankle-brachial pressure index (ABPI) >0.8 5. Has given consent to participate in the study 6. Needs compression treatment class 2 or class 3 (23-32 mmHg and 34-46 mmHg, respectively according to the RAL-GZG/ENV standard) 7. Aged 18 years or above
Exclusion criteria
Exclusion criteria: 1. Venous insufficiency classified C1 and C2 according to the Clinical-Aetiology-Anatomic-Pathophysiologic (CEAP) system 2. Arterial insufficiency 3. Ankle-brachial pressure index (ABPI) <0.8 4. Leg circumference less than 20 cm or greater than 65 cm 5. Poor or no tolerance of compression 6. Lipoedema 7. Diabetes 8. Heart failure 9. Other conditions that, in the examiner's opinion, restrict the patient from participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of oedema assessed by measuring the circumference of the lower leg will be measured every 4 cm, with start at a predetermined and well-defined zero point with a specially designed tape measure (Perikit) at baseline and at the end of the 2-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stocking compression pressure at baseline and after 2 weeks measured using two pressure sensors (Picopress®, Microlab, Italy) placed on two defined sites - just above the ankle and above the place where the calf has its largest circumference 2. Participant’s compliance assessed at the end of the 2-week treatment period by asking them how many days they used the stockings 3. Participant’s perceptions of the compression stocking's comfort assessed using a 1-10 scale at the end of the 2-week treatment period 4. Participant’s perceptions of the compression stocking's usefulness assessed using a 1-10 scale at the end of the 2-week treatment period 5. Participant’s perceptions of symptom relief provided by the compression stocking assessed using a 1-10 scale at the end of the 2-week treatment period | — |
Countries
Sweden
Outcome results
None listed