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New wound pump shows promise for stubborn leg ulcers

NCT ID NCT06510777

Symptom relief Sponsor: Smith & Nephew, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a single-use negative pressure wound therapy system (PICO) helps heal hard-to-treat venous leg ulcers better than standard care. About 142 adults with leg ulcers that had lasted at least 6 weeks took part. The main goal was to see if more ulcers healed completely within 12 weeks with the PICO device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

142 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous insufficiency Venous leg ulcer

Contacts and locations

Locations

  • CICA+

    Dardilly, France

  • Cabinet Médical

    Vandœuvre-lès-Nancy, France, France

  • Cabinet Médical

    Béziers, France

  • Cabinet Médical

    Cahors, France

  • Cabinet Médical

    Langon, France

  • Cabinet Médical

    Paris, France

  • Cabinet Médical

    Saint-Alban, France

  • Cabinet Médical

    Thionville, France

  • Cabinet Médical

    Wattignies, France

  • Cabinet Médical Gambetta Paymal (CMPG)

    Clichy, France

  • Cabinet Privé

    Antibes, France

  • Cabinet Privé

    Idron, France

  • Cabinet Privé

    Rambouillet, France

  • Cabinet Privé

    Saint-Gély-du-Fesc, France

  • Cabinet Privé

    Sarreguemines, France

  • Cabinet Privé Soyaux

    Soyaux, France

  • Cabinet d'Angiologie et de Médecine Vasculaire

    Saint-Priest, France

  • Cabinet d'angiologie de Pont-l'Abbé

    Pont-l'Abbé, France

  • Cabinet de Médecine Vasculaire

    Bourg-en-Bresse, France

  • Cabinet de Médecine Vasculaire - Angiologie

    Arignac, France

  • Cabinet privé

    Pontcharra, France

  • Centre Léon Blum

    Villeurbanne, France

  • Centre Privé de Consultations Médico-Chirurgicales

    Saumur, France

  • Centre de Médecine Vasculaire

    Rodez, France

  • Cicadom

    Challes-les-Eaux, France

  • Cicadom

    Guilherand-Granges, France

  • Cicadom

    Le Coteau, France

  • Cicadom

    Saint-Nazaire, France

  • Clinique Megival

    Saint-Aubin-sur-Scie, France

  • Clinique Mégival

    Saint-Aubin-sur-Scie, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Rhône Durance

    Avignon, France

  • Clinique St. Charles

    La Roche-sur-Yon, France

  • Clinique d'Argonay

    Argonay, France

  • Clinique de L'Atlantique

    Puilboreau, France, France

  • Clinique des Augustines

    Malestroit, France

  • GCS Pôle Santé de Cahors

    Cahors, France

  • Maison de Santé d'Etauliers

    Étauliers, France

  • One Clinic

    Plaisir, France

  • Polyclinique de Picardie

    Amiens, France

  • Polyclinique de Picardie

    Sainte-Maxime, France

  • Pôle Santé

    Montélimar, France

  • Sui'vui Santé

    Château-Renault, France

  • Synartis

    Aire-sur-la-Lys, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.