An observational study in Healthy Volunteers, sponsored by Lohmann & Rauscher. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Lohmann & Rauscher · Observational
The goal of this study is to learn about the pressure that can be maintained by a new compression bandage over the course of seven days in healthy volunteers. This bandage combines skin protection, padding and compression in one single bandage. It will be applied to the participants lower legs. A similar device will be applied to the other lower leg of the participant. A randomisation method is used for the assignment of the bandages to the participants legs.
Researchers will compare the bandage pressures of both bandages. The so-called sub-bandage pressure will be measured at the day of application and on the next day, the third day and the last day. Participants will also be asked about the wearing comfort of both bandages.
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Apparently healthy volunteers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Static Stiffness Index SSI
The static stiffness index is the sub-bandge pressure difference between active standing and lying.
Time frame: Day 0
Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages
The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.
Time frame: Day 0 + 6 days
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better
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.
Time frame: Day 0 + 6 days
Investigational Device
| Milestone | Investigational Device | Comparator Device |
|---|---|---|
| Started | 22 | 22 |
| Completed | 19 | 19 |
| Not completed | 3 | 3 |
The static stiffness index is the sub-bandge pressure difference between active standing and lying.
| mmHg | Investigational Device | Comparator Device |
|---|---|---|
| Static Stiffness Index SSI | 10 ± 7 | 12 ± 9 |
The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.
| mmHg | Investigational Device | Comparator Device |
|---|---|---|
| Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages | 19 ± 9 | 12 ± 7 |
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.
| Participants | Investigational Device | Comparator Device |
|---|---|---|
| Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better | 18 ± 13 | 18 ± 12.5 |
Collected over From enrollment until end of follow-up, one week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Device | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| Comparator Device | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| Event | Investigational Device | Comparator Device |
|---|---|---|
| Allergy against one component within the investigational and comparator bandageSkin and subcutaneous tissue disorders | 1/22 | 1/22 |
| Age, Categorical(Participants) | Healthy Volunteers |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 0 |
| Age, Continuous(years) | Healthy Volunteers |
|---|---|
| Mean | 33 (21 to 57) |
| Sex: Female, Male(Participants) | Healthy Volunteers |
|---|---|
| Female | 14 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Healthy Volunteers |
|---|
| Region of Enrollment(participants) | Healthy Volunteers |
|---|---|
| Italy | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2025 to primary completion in Mar 2025, 1 month.
Results were first posted in Aug 2026, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Lohmann & Rauscher