Healthy SubjectsFUSIONNCT04159844
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
A study testing URGOBD001 and URGOBD001 associated with wading in people with Healthy Subjects, run by Laboratoires URGO at 1 site in France.
Trial summary
This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- URGOBD001 and URGOBD001 associated with wading
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2019to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with a body mass index of less than 30 (BMI = kg / m²),
- Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
- Subject presenting a venous doppler of the lower limbs without detectable anomaly
- Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
- Subject accepting to wear a compressive system on both legs for a period of three days.
Who cannot join
- Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
- Subject with type I or II diabetes
- Subject with lipoedema and / or dismorphic leg
- Subject presenting ankle ankylosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intertek France Clinical studies
Paris, 75013
About this study
This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.
Read the detailed description
Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.
The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).
- Conditions
- Healthy Subjects
- Being tested
- URGOBD001, URGOBD001 associated with wading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGOBD001Device
Application with 50% overlapping
URGOBD001 associated with wadingDevice
Application with 50% overlapping in association with wading
| Study group | Role | What they receive |
|---|---|---|
| Short stretch bandage | Active comparator | Application with 50% overlap in combinaison with wading Receives: Device: URGOBD001 |
| Multi componant bandage | Active comparator | Application with 50% overlap Receives: Device: URGOBD001 |
| Short stretch bandage bis | Active comparator | Application with 50% overlap in combinaison with wading Receives: Device: URGOBD001 associated with wading |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI(Static Stiffness Index) ≥ 10 mmHg
% of subject with a SSI≥ 10 mmHg
Measured: Hour 48 after the application
Secondary outcomes (3)
SSI (Static Stiffness Index)
Evolution over time
Measured: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Interface pressure under the bandage
Evolution over time
Measured: From Hour 0 (Baseline) to Hour 72 after application
Slippage of the bandage in cm
Assessed by measuring with a tape at each time (i) the length (L) from the top of the bandage to the floor, Slippage (cm) = L(Time 0) - L (Time i)
Measured: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start3 Sep 2019
- Primary completion29 Nov 2019 (estimated)
- Study completion29 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 separate sets : * URGOBD001 SSI compared with the SSI of a short stretch bandage * URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage * URGOBD001 SSI compared with the SSI of a multi component bandage.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benigni JP, MD, Principal investigator, Intertek France clinical studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159844
- Sponsor's protocol ID
- F-19-06-BD001
- Acronym
- FUSION
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
- ClinicalTrials.gov ID
- NCT04159844
- Acronym / sponsor ID
- FUSION / F-19-06-BD001
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 29 Nov 2019 (estimated)
- Study completion
- 29 Nov 2019 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.
Detailed description
Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.
The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 separate sets : * URGOBD001 SSI compared with the SSI of a short stretch bandage * URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage * URGOBD001 SSI compared with the SSI of a multi component bandage.
| Arm | Type | Receives |
|---|---|---|
| Short stretch bandage | Active comparator | Device: URGOBD001Application with 50% overlap in combinaison with wading |
| Multi componant bandage | Active comparator | Device: URGOBD001Application with 50% overlap |
| Short stretch bandage bis | Active comparator | Device: URGOBD001 associated with wadingApplication with 50% overlap in combinaison with wading |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with a body mass index of less than 30 (BMI = kg / m²),
- Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
- Subject presenting a venous doppler of the lower limbs without detectable anomaly
- Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
- Subject accepting to wear a compressive system on both legs for a period of three days.
Key exclusion criteria (4 listed)
- Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
- Subject with type I or II diabetes
- Subject with lipoedema and / or dismorphic leg
- Subject presenting ankle ankylosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URGOBD001Application with 50% overlapping | Device | Multi componant bandage, Short stretch bandage |
| URGOBD001 associated with wadingApplication with 50% overlapping in association with wading | Device | Short stretch bandage bis |
Primary outcome
SSI(Static Stiffness Index) ≥ 10 mmHg
Time frame: Hour 48 after the application
% of subject with a SSI≥ 10 mmHg
3 secondary outcomes
SSI (Static Stiffness Index)
Time frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Interface pressure under the bandage
Time frame: From Hour 0 (Baseline) to Hour 72 after application
Slippage of the bandage in cm
Time frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benigni JP, MD principal investigator
Intertek France clinical studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URGOBD001 and URGOBD001 associated with wading in people with Healthy Subjects, run by Laboratoires URGO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Batot Géraldine, PhD (+33 3 80 44 28 46, g.batot@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI(Static Stiffness Index) ≥ 10 mmHg (time frame: Hour 48 after the application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.