Venous Leg UlcerFREEDOMNCT04613687
Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)
A study testing Compression bandage in people with Venous Leg Ulcer, run by Laboratoires URGO.
Trial summary
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Compression bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2020to 30 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
- Wound in granulation phase (granulation tissue ≥50%),
- Wound at least 3 cm away from any edge of another wound,
- VLU between 2 and 20 cm2 in surface area,
- VLU duration between 1 to 24 months.
Who cannot join
- Patient under guardianship or protection of vulnerable adult,
- Patient with known allergy to any components of the tested compression system,
- Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
- Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
- Patient with non-controlled systemic infection by a suitable antibiotic therapy,
- Patient who had a deep vein thrombosis within 3 months prior to the inclusion,
Show all 13Show fewer
- Patient with a lymphedema due to lymphatic obstruction,
- Diabetic patient with advanced diagnosed microangiopathy,
- Bedridden patient, or those spending less than one hour per day on their feet,
- Wound covered partially or totally with necrotic tissue,
- Clinically infected wound,
- Wound requiring surgical treatment or for which a surgery is scheduled during the study period,
- Cancerous lesions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.
Read the detailed description
The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression.
The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.
- Conditions
- Venous Leg Ulcer
- Being tested
- Compression bandage
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandageDevice
Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
| Study group | Role | What they receive |
|---|---|---|
| URGOBD001 | Experimental | Compression bandage Receives: Device: Compression bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative reduction in wound surface area (percent)
Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = [(SW6 - SD0)/SD0] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6
Measured: 6 weeks
Secondary outcomes (5)
Complete ulcer closure:
The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period
Measured: 6 weeks or last assessment
Venous oedema
Oedema reduction from baseline (D0) and last assessment by measuring the limb circumference (in cm), using a tape:
- Ankle circumference at the reference point B (smallest perimeter of the leg, 3 cm above medial malleolus,
- Calf circumference at the reference point C (maximum perimeter of the calf).
Measured: 6 weeks or last assessment
Patient quality of Life (EuroQoL 5D-5L)
EuroQoL 5D-5L between baseline and at last visit. The questionnaire essentially consists of a descriptive system including 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analogue scale (EQ VAS) from "the worst health you can imagine" (0) to "the best health you can imagine" (100).
Measured: 6 weeks or last assessment
Evolution of the periwound skin
Evolution of the peri-wound skin at each visit according to the following parameters:
- Healthy
- Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other
Measured: 6 weeks or last assessment
Safety analysis
Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)
Measured: 6 weeks or last assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start30 Oct 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi centre, non-comparative study
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senet Patricia, MD, Principal investigator, Vascular dermatologist, APHP, Paris, FranceDissemond Joachim, MD, Principal investigator, Clinic for dermatology, Essen- Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613687
- Sponsor's protocol ID
- FI-19-09-BD001
- Acronym
- FREEDOM
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 3 Nov 2020
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT04613687
- Acronym / sponsor ID
- FREEDOM / FI-19-09-BD001
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 3 Nov 2020 (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.
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.
Detailed description
The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression.
The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi centre, non-comparative study
| Arm | Type | Receives |
|---|---|---|
| URGOBD001 | Experimental | Device: Compression bandageCompression bandage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
- Wound in granulation phase (granulation tissue ≥50%),
- Wound at least 3 cm away from any edge of another wound,
- VLU between 2 and 20 cm2 in surface area,
- VLU duration between 1 to 24 months.
Key exclusion criteria (13 listed)
- Patient under guardianship or protection of vulnerable adult,
- Patient with known allergy to any components of the tested compression system,
- Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
- Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
- Patient with non-controlled systemic infection by a suitable antibiotic therapy,
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 |
|---|---|---|
| Compression bandageCompression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous | Device | URGOBD001 |
Primary outcome
Relative reduction in wound surface area (percent)
Time frame: 6 weeks
Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = [(SW6 - SD0)/SD0] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6
5 secondary outcomes
Complete ulcer closure:
Time frame: 6 weeks or last assessment
Venous oedema
Time frame: 6 weeks or last assessment
Patient quality of Life (EuroQoL 5D-5L)
Time frame: 6 weeks or last assessment
Evolution of the periwound skin
Time frame: 6 weeks or last assessment
Safety analysis
Time frame: 6 weeks or last assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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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.
Senet Patricia, MD principal investigator
Vascular dermatologist, APHP, Paris, France
Dissemond Joachim, MD principal investigator
Clinic for dermatology, Essen- Germany
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandage in people with Venous Leg Ulcer, run by Laboratoires URGO.
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 13 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Relative reduction in wound surface area (percent) (time frame: 6 weeks). 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 3 Nov 2020.