Comparing two compression stockings in people with oedema (swelling caused by fluid collection) in the legs

Not Applicable

Completed

• Conditions: Chronic venous insufficiency (CVI), deep vein thrombosis, lymphedema; Circulatory System

• Registration Number: ISRCTN17356077
• Lead Sponsor: PressCise (Sweden)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37696041/ (added 12/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-24
• Study Completion: 2021-02-21
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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<br> 2. Participant’s compliance assessed at the end of the 2-week treatment period by asking them how many days they used the stockings<br> 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<br> 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<br> 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<br>