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Venous InsufficiencyNCT06510777

PICO Venous Leg Ulcers (VLU) Reimbursement Study

A study testing PICO Treatment in people with Venous Insufficiency and Venous Leg Ulcer, run by Smith & Nephew, Inc. at 44 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Insufficiency, Venous Leg Ulcer
What is being tested?
PICO Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
44 sitesFrance
Study dates
29 Dec 2023to 24 Oct 2025
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

  • Subject signed informed consent
  • Both gender adult ≥ 18 years old
  • Venous leg ulcer (VLU) diagnosed by:
  • ABPI ≥ 0.7 and < 1.3 within the last 3 months
  • If ABPI < 1.3, one of the following measures should be available:
  • Toe Brachial Pressure Index (TBPI) > 0.7
Show all 16Show fewer
  • Toe pressure (TP) > 50 mmHg
  • Transcutaneous oxygen pressure (TcPO2) > 30 mmHg
  • VLU duration ≥ 6 weeks
  • VLU surface area:
  • Isolated leg ulcer: ≤ 100 cm^2
  • Non-isolated leg ulcers: pooled surface area ≤ 100 cm^2 that can be covered by a single dressing
  • Exuding VLU according to clinical judgement
  • The subject is in acceptable state of health and nutrition according to clinical judgement
  • The subject is able to follow the protocol instruction and willing to comply with compression therapy
  • The subject is affiliated to a French Health insurance scheme

Who cannot join

  • Clinical evidence of VLU infection [i.e. presence of at least 3 overt signs of local infection (e.g., erythema, warmth, swelling, pain, odor) or signs of spreading or systemic infection)
  • Wound with necrotic tissue after debridement
  • Sloughy wound (100% of slough) after debridement
  • Exposed arteries, veins, nerves or organs
  • Current therapy with chronic oral corticosteroids (>10 days)
  • Previous therapy with negative pressure wound therapy device or hyperbaric oxygen within 7 days prior to enrolment
Show all 11Show fewer
  • Arterial insufficiency non-revascularized
  • Wound actively bleeding
  • Malignant wound
  • Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial
  • Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision cannot take part in clinical investigations) and 68 (patients in emergency situation) of the Medical Device Regulation

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

France44 sites

  • Synartis

    Aire-sur-la-Lys

  • Polyclinique de Picardie

    Amiens

  • Cabinet Privé

    Antibes

  • Clinique d'Argonay

    Argonay

  • Cabinet de Médecine Vasculaire - Angiologie

    Arignac

  • Clinique Rhône Durance

    Avignon

  • Cabinet Médical

    Béziers

  • Cabinet de Médecine Vasculaire

    Bourg-en-Bresse

  • Cabinet Médical

    Cahors

  • GCS Pôle Santé de Cahors

    Cahors

  • Cicadom

    Challes-les-Eaux

  • Sui'vui Santé

    Château-Renault

  • Cabinet Médical Gambetta Paymal (CMPG)

    Clichy

  • CICA+

    Dardilly

  • Maison de Santé d'Etauliers

    Étauliers

  • Cicadom

    Guilherand-Granges

  • Cabinet Privé

    Idron

  • Clinique St. Charles

    La Roche-sur-Yon

  • Cabinet Médical

    Langon

  • Cicadom

    Le Coteau

  • Clinique des Augustines

    Malestroit

  • Pôle Santé

    Montélimar

  • Cabinet Médical

    Paris

  • One Clinic

    Plaisir

  • Cabinet d'angiologie de Pont-l'Abbé

    Pont-l'Abbé

  • Cabinet privé

    Pontcharra

  • Clinique de L'Atlantique

    Puilboreau, France

  • Cabinet Privé

    Rambouillet

  • Centre de Médecine Vasculaire

    Rodez

  • Cabinet Médical

    Saint-Alban

  • Clinique Megival

    Saint-Aubin-sur-Scie

  • Clinique Mégival

    Saint-Aubin-sur-Scie

  • Cabinet Privé

    Saint-Gély-du-Fesc

  • Cicadom

    Saint-Nazaire

  • Cabinet d'Angiologie et de Médecine Vasculaire

    Saint-Priest

  • Polyclinique de Picardie

    Sainte-Maxime

  • Cabinet Privé

    Sarreguemines

  • Centre Privé de Consultations Médico-Chirurgicales

    Saumur

  • Cabinet Privé Soyaux

    Soyaux

  • Cabinet Médical

    Thionville

  • Clinique Pasteur

    Toulouse

  • Cabinet Médical

    Vandœuvre-lès-Nancy, France

  • Centre Léon Blum

    Villeurbanne

  • Cabinet Médical

    Wattignies

Other trials in France

About this study

Official title: A Pragmatic, Multi-centre, Prospective, Randomized, Superiority Study to Compare the Performance of the Single-use Negative Pressure Wound Therapy System PICO Versus Standard of Care in the Management of Venous Leg Ulcers

This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners. The primary endpoint is the incidence of confirmed healed VLUs at 12 weeks or before, in the PICO treatment group versus the SOC group. The study hypothesis is based on the Kirsner study (Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. 2019 Sep;27(5):519-529)), which compared PICO treatment to traditional NPWT (t-NPWT); the ITT analysis in the subgroup of patients with VLU showed 45.1% wound closure (confirmed wound healing) at 12 weeks in the PICO group as compared to 28% in the t-NPWT group, yielding a difference of 17.1%, 95% Confidence Interval = (-1.9%;+35.4%). For our study, the Sponsor made the assumptions that the t-NPWT healing proportion (28%) can be used as conservative estimate for the control group proportion and that the PICO group should provide at least a 17% improvement over standard of care. Adaptative design is chosen to adjust the sample size using the re-assessment size method to preserve alpha risk (α) level.

Read the detailed description

This is a national, multicentre, pragmatic, randomized, controlled superiority study in which PICO treatment with compression therapy will be compared against Standard of Care (i.e. traditional wound dressings with compression therapy). There will be two parallel treatment arms with a 1:1 allocation ratio and a stratification on wound duration and size. There will be an additional blind assessment for the primary outcome measure.

Approximately 37 investigational sites located in France will be enrolled. At each site, a community-based practitioner (general practitioner or specialist) will be enrolled as Principal Investigator (PI). District nurses will be responsible for providing wound care in homecare setting. Duly informed and eligible patients will complete an inclusion visit after which they will enter in a 2-week run-in period in which subjects will be treated with standard of care. After these 2 weeks of run-in, eligibility to randomization will be assessed using pre-specified criteria listed in the protocol, that aim to confirm that the wound does not respond to an adequately conducted standard of care in a satisfactory manner, including subject compliance with compression therapy.

Upon randomization, baseline data will be collected, and each subject will be followed-up by the PI for 12 weeks. The PI will conduct 3 visits, i.e., at Week 4 (D28±3 days), Week 8 (D56±3 days), and Week 12 (D84±3 days). Relevant study data will be collected at these visits. In the event wound healing is observed during the 12-week follow-up period of the study either by the PI or by the home care nurse, a Wound Healing Confirmation Visit needs to be conducted with the PI 2 weeks later (±3 days) to confirm that the wound is still healed. Only wounds still healed at the wound healing confirmation visit will be counted as "healed" in the primary endpoint analysis. This means that for wounds that are not healed by Week 12, the visit with the PI at Week 12 will be the final study visit for the subject. Following, because a Wound Healing Confirmation Visit needs to be conducted 2 weeks (±3 days) following the initial observation of wound healing, which can occur at any time throughout the 12 week follow-up period, the Wound Healing Confirmation Visit can occur at any time as well, but at the latest 2 weeks (±3 days) following the visit at Week 12, i.e. at week 14±3 days.

In between study visits with the PI, patients are cared for at home by their home care nurse who will also be trained on the study. The study nurse will be collecting study related data as well using a secure mobile application.

Being tested
PICO Treatment, Standard of Care (SOC) Treatment
Keywords
Venous Leg Ulcer, Negative Pressure Wound Therapy, NPW, Hard-to-Heal Venous Leg Ulcer, Community Care
Medical subject headings
Venous Insufficiency, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICO TreatmentDevice

    Also called Single-Use Negative Pressure Therapy System PICO 7 (sNPWT)

    PICO 7 is a single-use Negative Pressure Wound Therapy System consisting of a small portable pump, 2 AA batteries, 1 or 2 dressings, and fixation strips. The dressing is changed when the dressing is saturated or after 7 days of treatment.

    PICO Treatment will be given in addition to compression therapy.

    If the wound is healed and until the wound healing confirmation visit, Venous Leg Ulcers (VLUs) allocated to the PICO group may be covered using a protective dressing.

    If the wound meets the wound improvement criteria as assessed by the PI during the monthly visits, PICO treatment may be stopped.

  • Standard of Care (SOC) TreatmentDevice

    Also called Traditional wound dressings in addition to compression therapy.

    Application of an appropriate wound primary dressing according to its intended purpose and chosen appropriately according to wound healing stage:

    1. Dressing choice should take wound condition into consideration but may also consider subject's comfort (including pain) and HCP's preference.
    2. Sequential treatment:
    • Debridement stage: alginate, hydrogel, absorbent, or hydro-detersive dressings
    • Granulation stage: wound contact layer, foam, petrolatum, or hydrofiber dressings
    • Epithelialization stage: wound contact layer, hydrocolloids
    • Other: dressings for specific clinical situations (e.g. fragile skin, infection; hemorrhagic wound, malodorous wound)
    1. Application of appropriate venous compression therapy based on Ankle Brachial Pressure Index (ABPI) value.
Study groups in NCT06510777
Study groupRoleWhat they receive
PICO Treatment ArmExperimentalThe maximum duration for treatment with PICO will be 12 weeks. PICO treatment will be discontinued if the wound does not respond to treatment after 2 weeks according to predefined criteria, if the wound gets worse at any time, if the wound is 100% epithelialized, or if the wound presents advanced healing, which will be assessed using predefined criteria. In the latter case where the VLU is determined sufficiently healed according to the pre-specified criteria in the protocol, subjects will be switched to Standard of Care (SOC). Wound care treatment at home will be done by home care nurses. Compression therapy will be maintained throughout the entire patient's follow-up.
Receives: Device: PICO Treatment; Device: Standard of Care (SOC) Treatment
Standard of Care Treatment ArmActive comparatorWounds are treated with appropriate traditional dressings throughout the study based on wound condition and healing trajectory. Wound care treatment at home will be done by home care nurses. Compression therapy will be maintained throughout the entire patient's follow-up.
Receives: Device: Standard of Care (SOC) Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks

    The primary endpoint is the incidence of confirmed healed Venous Leg Ulcers (VLUs) at 12 weeks or before in PICO versus SOC group.

    A confirmed healed VLU is defined as a wound with complete closure (100% epithelialization) according to PI's judgement during two visits that are two weeks apart (±3 days) AND confirmed by a blind assessment board based on blinded photograph examination.

    Measured: Up to 12 weeks

Secondary outcomes (11)

  1. Time to Achieve Wound Healing

    Number of days required from baseline to achieve wound healing where the wound is observed with complete closure (100% epithelialization).

    Measured: Up to 12 Weeks

  2. Relative Wound Area Reduction (RWAR)

    Relative wound area reduction (RWAR) at Week 4, Week 8 and at the Final Visit i.e., visit at Week 12 or the Wound Healing Confirmation Visit.

    Measured: Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3days)

  3. Time to achieve 100% healthy granulation tissue

    Number of days required to achieve 100% granulation over 12 weeks

    Measured: Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3 days)

  4. Changes in quality of life using the generic EuroQol 5 Dimension (EQ-5D-5L )

    Changes in quality of life from baseline to the final visit (i.e., the visit at Week 12 or the Wound Healing Confirmation Visit).

    The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. A higher number is a better outcome.

    Measured: Day 0 to Week 12 (up to 14 weeks ±3 days)

  5. Changes in quality of life using the disease specific VEINES-Qol (Venous Insufficiency Epidemiological and Economic Study on Quality of Life) questionnaire

    Changes in quality of life from baseline to the Final Visit (i.e., the visit at Week 12 or the Wound Healing Confirmation Visit).

    The VEINES-QOL questionnaire consists of 26 items. It includes questions about symptoms due to Chronic Venous Disorders of the Leg (CVDL) (ten items), limitations in daily activities due to CVDL (nine items) and psychological impact (five items), as well as questions asking about the amount of change in the respondent's leg problem over a 1-year period (one item) and the time of day that the leg problem is most intense (one item).

    Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense (question 2), provides only descriptive information and is not scored. High values indicate better outcomes.

    Measured: Day 0 to Week 12 (up to 14 weeks ±3 days)

  6. Number of Adverse Events

    Number of participants with an adverse event

    Measured: Day 0 to Week 12 (up to 14 weeks ±3 days)

  7. Number of device deficiencies

    Number of participants with a device deficiency

    Measured: Day 0 to Week 12 (up to 14 weeks ±3 days)

  8. Visual Analog Scale (VAS) score at dressing removal (PICO Treatment Arm only)

    Pain scores on removal of the dressing measured using a 0-100 Visual Analog Scale (VAS) score, with zero (0) indicating no pain and 100 indicating the worst possible pain.

    Measured: Day 0 to Week 12 (up to 14 weeks±3 days)

  9. VLU treatment impact on mobility and physical activity using a 5 point-Likert scale

    Venous Leg Ulcers (VLU) treatment impact on mobility and physical activity using a 5 point-Likert scale: (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree)

    Measured: Week 4, Week 8, Week 12 (up to 14 weeks±3 days)

  10. Healthcare Practitioner (HCP) satisfaction assessed using a 5 point-Likert scale questionnaire

    Analysis of HCP satisfaction with PICO treatment assessed using a 5 point-Likert scale questionnaire (PICO treatment group only): (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree)

    Measured: Week 12 (up to 14 weeks±3 days)

  11. Subject satisfaction assessed using a 5 point-Likert scale questionnaire

    Analysis of subject satisfaction with PICO treatment assessed using a 5 point-Likert scale questionnaire (PICO treatment group only): (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree)

    Measured: Week 12 (up to 14 weeks ±3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start29 Dec 2023
  3. Primary completion24 Oct 2025
  4. Study completion24 Oct 2025

Why it stopped: Early terminated due to protocol design issues with inability to correct at this stage.

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510777
Sponsor's protocol ID
PICO.2021.09
Other IDs
2023-A01760-45
Status last verified
Jan 2026
First submitted
15 Jul 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PICO Treatment in people with Venous Insufficiency and Venous Leg Ulcer, run by Smith & Nephew, Inc. at 44 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 16 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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?

The study was stopped early (reason given: Early terminated due to protocol design issues with inability to correct at this stage.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06510777.

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 8 Jan 2026.

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