Trial Outcomes & Findings for Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations (NCT NCT04637997)

Last Updated: 2021-03-16

Results Overview

Determination and comparison of volume difference of the malformation after application of compression stockings class I and II compared to baseline (no compression) measured non-invasively by MRI.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

one day

Results posted on

2021-03-16

Participant Flow

Participants were informed about the possibility of participating in the study during a routine presentation of the vascular surgery consultation Hours during 01.10.2017-01.12.2018.

Participant milestones

Participant milestones
Measure	Study Group 1 Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84. compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity. compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity.	Study Group 2 Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84. compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity. compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group 1 n=9 Participants Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84. compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity. compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity.	Study Group 2 n=9 Participants Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84. compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity. compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity.	Total n=18 Participants Total of all reporting groups
Age, Continuous	26.22 years STANDARD_DEVIATION 18.91 • n=9 Participants	28.11 years STANDARD_DEVIATION 15.5 • n=9 Participants	27.17 years STANDARD_DEVIATION 24.45 • n=18 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	6 Participants n=9 Participants	12 Participants n=18 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	3 Participants n=9 Participants	6 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants
Affected part of body arm	4 Participants n=9 Participants	1 Participants n=9 Participants	5 Participants n=18 Participants
Affected part of body lower limb	3 Participants n=9 Participants	2 Participants n=9 Participants	5 Participants n=18 Participants
Affected part of body upper limb	2 Participants n=9 Participants	4 Participants n=9 Participants	6 Participants n=18 Participants
Affected part of body upper and lower limb	0 Participants n=9 Participants	2 Participants n=9 Participants	2 Participants n=18 Participants
Previous therapy	5 Participants n=9 Participants	3 Participants n=9 Participants	8 Participants n=18 Participants

PRIMARY outcome

Timeframe: one day

Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.

Determination and comparison of volume difference of the malformation after application of compression stockings class I and II compared to baseline (no compression) measured non-invasively by MRI.

Outcome measures

Outcome measures
Measure	Compression Stockings Class I n=18 Participants Wearing of compression stockings class I on the affected extremity.	Compression Stockings Class II n=18 Participants Wearing of compression stockings class II on the affected extremity.
Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI	16.38 ml Standard Deviation 18.28	23.7 ml Standard Deviation 25.67

PRIMARY outcome

Timeframe: one day

Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.

Determination and comparison of volume difference of the affected extremity after application of compression stockings class I and II compared to baseline (no compression) measured non-invasively by perometre.

Outcome measures

Outcome measures
Measure	Compression Stockings Class I n=18 Participants Wearing of compression stockings class I on the affected extremity.	Compression Stockings Class II n=18 Participants Wearing of compression stockings class II on the affected extremity.
Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre	124 ml Standard Deviation 351.09	90.22 ml Standard Deviation 226.7

SECONDARY outcome

Timeframe: up to two months

Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.

SF-12v2 (SOEP-Version 2004) scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental (MCS) and physical (PCS) functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The overall mean for each scale is 50 points and the standard deviation is 10 points in the SOEP sample.

Outcome measures

Outcome measures
Measure	Compression Stockings Class I n=18 Participants Wearing of compression stockings class I on the affected extremity.	Compression Stockings Class II n=18 Participants Wearing of compression stockings class II on the affected extremity.
Difference Between Quality of Life at Baseline (no Compression at Day 28) and Compression Classes I and II by Short Form-12 (SF-12) Health Survey at Day 56 or 84 PCS	1.9505 units on a scale Standard Deviation 7.2323	3.3461 units on a scale Standard Deviation 7.321
Difference Between Quality of Life at Baseline (no Compression at Day 28) and Compression Classes I and II by Short Form-12 (SF-12) Health Survey at Day 56 or 84 MCS	1.0922 units on a scale Standard Deviation 9.6244	0.1778 units on a scale Standard Deviation 6.865
Difference Between Quality of Life at Baseline (no Compression at Day 28) and Compression Classes I and II by Short Form-12 (SF-12) Health Survey at Day 56 or 84 Overall Health-related Quality of life	1.5214 units on a scale Standard Deviation 4.24	1.762 units on a scale Standard Deviation 3.164

Adverse Events

Compression Stockings Class I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Compression Stockings Class II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. med. Antje Mükke

University Hospital Erlangen, Vascular Surgery

Phone: +4991318532968

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place