Venous Leg Ulcer (VLU)NCT07600489
A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
A study testing Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®) and Wound Dressing Material in people with Venous Leg Ulcer (VLU) and Compression Bandages, run by Molnlycke Health Care AB at 8 sites in France.
Trial summary
Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU), Compression Bandages
- What is being tested?
- Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®) and Wound Dressing Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 8 sitesFrance
- Study dates
- May 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients ≥ 18 years.
- Stage C6 venous leg ulcer diagnosed less than 24 months ago.
- 2cm² ≤ VLU surface area ≤ 40cm².
- ABPI equal or higher than 0.8 and equal or lower than 1.3.
- Able to read, understand and speak French for their medical care.
- Agreeing to follow the procedures described in the CIP.
- Benefiting from a social insurance coverage.
Who cannot join
- Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.
- Planned endovenous treatment or surgical venous stripping / exeresis within 8 weeks before planned inclusion date, or before end of participation to the study.
- Treatment with chemotherapy or antineoplastic agent within the last 6 months.
- Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings.
- Pregnant or breastfeeding women.
- Persons deprived from their liberty.
- Persons protected under guardianship or curatorship.
- Any person who, as per investigator's decision, is not suitable to participate in the investigation for any other reason.-
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Clinique du Parc-Montpellier
Castelnau-le-Lez
Principal Investigator, +33 4 67 33 13 31, c-geri@chu-montpellier.fr
CHU Michallon Grenoble
Grenoble
Coordinating Principal Investigator, +33 (0)4 76 76 75 75, sblaise@chu-grenoble.fr
Clinique du Parc Lyon
Lyon
Principal Investigator, +33 4 49 44 00 90, centreplaieslyon@protonmail.com
Hopital Edouard Herriot_HCL
Lyon
Principal Investigator, +33 4 72 11 80 88, judith.catella@chu-lyon.fr
CHU Nantes
Nantes
Principal Investigator, +33 2 40 08 33 33, cecile.durant@chu-nantes.fr
Poitiers Polyclinique
Poitiers
Principal Investigator, +33 5 49 61 70 00, dr.kassab@pdp86.fr
CHU Toulouse/Hopital Rangueil
Toulouse
Principal Investigator, +33 5 61 77 22 33, malloizel-delaunay.j@chu-toulouse.fr
Clinique Pasteur-Toulouse
Toulouse
Principal Investigator, +33 5 62 21 31 31, pleger@clinique-pasteur.com
About this study
Official title: A Comparative, Adaptive, Randomized, Non-Inferiority Clinical Investigation of Two-Layer Compression Bandages Mepi™ Press 2 Versus UrgoK2® in the Treatment of Venous Leg Ulcers
Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs.
The goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients.
Read more
The main question it aims to answer is:
-Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks?
Researchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved.
Participants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants.
Participants will:
- Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care
- Receive an appropriate primary wound dressing prior to compression
- Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first)
- Be assessed for wound healing, safety, and device performance throughout the study
- Conditions
- Venous Leg Ulcer (VLU), Compression Bandages
- Being tested
- Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®), Wound Dressing Material
- 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 bandage system (Mepi™ Press 2)Device
A two-layer compression system consisting of a padded bandage and a cohesive short-stretch bandage with visual indicator. Provides therapeutic compression to support venous leg ulcer management. Applied with an appropriate primary wound dressing and changed as clinically indicated.
Compression bandage system (UrgoK2®)Device
A two-layer compression system composed of a short-stretch bandage and a cohesive long-stretch bandage designed to achieve therapeutic compression (~40 mmHg). Used for venous leg ulcer management with an appropriate primary wound dressing.
Wound Dressing MaterialDevice
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Mepi™ Press 2- two-layer compression bandage | Experimental | Participants will receive compression therapy using Mepi™ Press 2 in accordance with standard of care for venous leg ulcer (VLU) management. Mepi™ Press 2 is a two-layer, short-stretch compression system consisting of a padded bandage and a cohesive compression bandage with visual application indicator. An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is intended to provide high working pressure and low resting pressure to support venous return and reduce edema. Single-use, non-sterile device. Receives: Device: Compression bandage system (Mepi™ Press 2); Device: Wound Dressing Material |
| UrgoK2® - multicomponent, compression system | Active comparator | Participants will receive compression therapy using UrgoK2® in accordance with standard of care for venous leg ulcer (VLU) management. UrgoK2® is a two-layer compression system consisting of a white short-stretch bandage (K-TECH) and a pink/beige cohesive long-stretch bandage (Kpress) with visual indicators to support correct application and achieve therapeutic compression (approximately 40 mmHg). An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is non-sterile, intended for single use, available in different sizes based on ankle circumference. Receives: Device: Compression bandage system (UrgoK2®); Device: Wound Dressing Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete healing of their VLU
Healing assessment is performed by the site investigator through clinical examination of the wound at the investigational site, during each of the follow-up visits.
Measured: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Secondary outcomes (8)
Compare reduction of VLU wound area (absolute and relative).
Absolute and percentage VLU wound surface area reduction compared to baseline at all follow-up visits .
Measured: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare proportions of participants reaching 40% wound area reduction at 4 weeks
Proportion of participants reaching ≥40% relative wound area reduction (RWAR) at 4 weeks
Measured: From enrollment to the follow-up visit at 4 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days)
Compare time to complete wound healing
Time to wound healed in each cohort, for patients with healed wound at termination.
Measured: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare quality-of-life during treatment and up to 12 weeks.
Quality of Life assessed with Wound-QoL-17 tool at each visit and change compared to baseline.
Measured: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0) , Visit 1 (D0 + 2 weeks ± 1 day) ,Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare comfort and usability as rated by the participant
At each follow-up visit, participants will complete a usability questionnaire including Likert scale assessments.
Measured: From enrollment to the end of treatment at 12 weeks, Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare usability as rated by the healthcare professional.
At each visit, the treating investigator will complete a usability questionnaire including Likert scale assessments; at baseline, only a limited set of questions will be collected.
Measured: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare device use including frequency of change
A summary and comparison of the compression use, including frequency of dressing/compression changes and primary dressing used, and type and size of compression used in relation to ankle size
Measured: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days),Visit 4 (D0 + 12 weeks ± 4 day)s
Compare safety profiles of both bandages.
A(D)E and SA(D)E and DD rates.
Measured: From enrollment to the end of treatment at 12 weeks,Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Arne Böhling, Study director, Mölnlycke Health Care AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600489
- Sponsor's protocol ID
- The Boa Clinical Investigation
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Adaptive, Randomized, Non-Inferiority Clinical Investigation of Two-Layer Compression Bandages Mepi™ Press 2 Versus UrgoK2® in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT07600489
- Acronym / sponsor ID
- The Boa Clinical Investigation
- Conditions
- Venous Leg Ulcer (VLU), Compression Bandages
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 May 2026 (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.
Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs.
The goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients.
The main question it aims to answer is:
-Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks?
Researchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved.
Participants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants.
Participants will:
- Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care
- Receive an appropriate primary wound dressing prior to compression
- Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first)
- Be assessed for wound healing, safety, and device performance throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepi™ Press 2- two-layer compression bandage | Experimental | Device: Compression bandage system (Mepi™ Press 2), Device: Wound Dressing MaterialParticipants will receive compression therapy using Mepi™ Press 2 in accordance with standard of care for venous leg ulcer (VLU) management. Mepi™ Press 2 is a two-layer, short-stretch compression system consisting of a padded bandage and a cohesive compression bandage with visual application indicator. An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is intended to provide high working pressure and low resting pressure to support venous return and reduce edema. Single-use, non-sterile device. |
| UrgoK2® - multicomponent, compression system | Active comparator | Device: Compression bandage system (UrgoK2®), Device: Wound Dressing MaterialParticipants will receive compression therapy using UrgoK2® in accordance with standard of care for venous leg ulcer (VLU) management. UrgoK2® is a two-layer compression system consisting of a white short-stretch bandage (K-TECH) and a pink/beige cohesive long-stretch bandage (Kpress) with visual indicators to support correct application and achieve therapeutic compression (approximately 40 mmHg). An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is non-sterile, intended for single use, available in different sizes based on ankle circumference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years.
- Stage C6 venous leg ulcer diagnosed less than 24 months ago.
- 2cm² ≤ VLU surface area ≤ 40cm².
- ABPI equal or higher than 0.8 and equal or lower than 1.3.
- Able to read, understand and speak French for their medical care.
Key exclusion criteria (8 listed)
- Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.
- Planned endovenous treatment or surgical venous stripping / exeresis within 8 weeks before planned inclusion date, or before end of participation to the study.
- Treatment with chemotherapy or antineoplastic agent within the last 6 months.
- Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings.
- Pregnant or breastfeeding women.
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 bandage system (Mepi™ Press 2)A two-layer compression system consisting of a padded bandage and a cohesive short-stretch bandage with visual indicator. Provides therapeutic compression to support venous leg ulcer management. Applied with an appropriate primary wound dressing and changed as clinically indicated. | Device | Mepi™ Press 2- two-layer compression bandage |
| Compression bandage system (UrgoK2®)A two-layer compression system composed of a short-stretch bandage and a cohesive long-stretch bandage designed to achieve therapeutic compression (~40 mmHg). Used for venous leg ulcer management with an appropriate primary wound dressing. | Device | UrgoK2® - multicomponent, compression system |
| Wound Dressing MaterialAppropriate primary wound dressing applied prior to compression therapy according to standard of care. | Device | Mepi™ Press 2- two-layer compression bandage, UrgoK2® - multicomponent, compression system |
Primary outcome
Percentage of patients with complete healing of their VLU
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Healing assessment is performed by the site investigator through clinical examination of the wound at the investigational site, during each of the follow-up visits.
8 secondary outcomes
Compare reduction of VLU wound area (absolute and relative).
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare proportions of participants reaching 40% wound area reduction at 4 weeks
Time frame: From enrollment to the follow-up visit at 4 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days)
Compare time to complete wound healing
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare quality-of-life during treatment and up to 12 weeks.
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0) , Visit 1 (D0 + 2 weeks ± 1 day) ,Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare comfort and usability as rated by the participant
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare usability as rated by the healthcare professional.
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Compare device use including frequency of change
Time frame: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days),Visit 4 (D0 + 12 weeks ± 4 day)s
Compare safety profiles of both bandages.
Time frame: From enrollment to the end of treatment at 12 weeks,Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Related trials for Venous Leg Ulcer (VLU)
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
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.
Arne Böhling study director
Mölnlycke Health Care AB
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®) and Wound Dressing Material in people with Venous Leg Ulcer (VLU) and Compression Bandages, run by Molnlycke Health Care AB at 8 sites 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+46 (0)31- 722 31 96, kristina.welinder@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete healing of their VLU (time frame: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s). 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 20 May 2026.