Trial Outcomes & Findings for Investigation of a New Compression Bandage System Combining Skin Protection, Padding and Compression in One Single Bandage and Comparing to an Existing One-component Bandage. (NCT NCT06728137)

Results Overview

The static stiffness index is the sub-bandge pressure difference between active standing and lying.

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

Day 0

Results posted on

2026-08-31

Participant Flow

Investigational Device

Unit of analysis: Legs

Participant milestones

Participant milestones
Measure	Investigational Device Investigational bandage assigned randomly to either leg of a participant.	Comparator Device Comparator bandage assigned randomly to either leg of a participant.
Overall Study STARTED	22 22	22 22
Overall Study COMPLETED	19 19	19 19
Overall Study NOT COMPLETED	3 3	3 3

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	Healthy Volunteers n=22 Participants The bandages were randomly assigned to the two legs of the participants.
Age, Categorical <=18 years	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants
Age, Continuous	33 years n=22 Participants
Sex: Female, Male Female	14 Participants n=22 Participants
Sex: Female, Male Male	8 Participants n=22 Participants
Region of Enrollment Italy	22 participants n=22 Participants

PRIMARY outcome

Timeframe: Day 0

The static stiffness index is the sub-bandge pressure difference between active standing and lying.

Outcome measures

Outcome measures
Measure	Investigational Device n=22 Participants Investigational device applied to lower legs	Comparator Device n=22 Participants Comparator device applied to lower legs
Static Stiffness Index SSI	10 mmHg Standard Deviation 7	12 mmHg Standard Deviation 9

SECONDARY outcome

Timeframe: Day 0 + 6 days

The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.

Outcome measures

Outcome measures
Measure	Investigational Device n=19 Participants Investigational device applied to lower legs	Comparator Device n=19 Participants Comparator device applied to lower legs
Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages	19 mmHg Standard Deviation 9	12 mmHg Standard Deviation 7

SECONDARY outcome

Timeframe: Day 0 + 6 days

Participants were asked on the last day how they rate the ankle mobility when wearing the bandages, using a 6-point scale from insufficient, poor, acceptable, good, very good, to excellant.

Outcome measures

Outcome measures
Measure	Investigational Device n=19 Participants Investigational device applied to lower legs	Comparator Device n=19 Participants Comparator device applied to lower legs
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better	18 Participants 13	18 Participants 12.5

Adverse Events

Investigational Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Comparator Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Investigational Device n=22 participants at risk Investigational device applied to lower legs	Comparator Device n=22 participants at risk Comparator device applied to lower legs
Skin and subcutaneous tissue disorders Allergy against one component within the investigational and comparator bandage	4.5% 1/22 • From enrollment until end of follow-up, one week	4.5% 1/22 • From enrollment until end of follow-up, one week

Additional Information

Christine Boehm

Lohmann & Rauscher GmbH & Co. KG

Phone: +492634996144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place