Home › Trials › NCT06510777

Comparing PICO treatment to standard care for hard-to-heal venous leg ulcers

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

Not applicable Interventional Smith & Nephew, Inc. · NCT06510777

This study is testing if a new PICO treatment combined with compression therapy helps people with hard-to-heal venous leg ulcers heal better than standard care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment294 (estimated)
Ages18 Years and up
SexAll
SponsorSmith & Nephew, Inc. Industry-sponsored
Locations44 sites (Aire-sur-la-Lys and 43 other locations)
Trial IDNCT06510777 on ClinicalTrials.gov

What this trial studies

This study aims to demonstrate the effectiveness of PICO treatment combined with compression therapy compared to standard care for patients with hard-to-heal venous leg ulcers (VLU). It is a multicenter, randomized, controlled trial involving approximately 37 sites across France, where patients will be treated for 12 weeks. Participants will first undergo a 2-week run-in period with standard care before being randomized to either the PICO treatment or standard care group. The primary outcome will be the incidence of confirmed healed VLUs at 12 weeks, assessed through blind evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosed venous leg ulcer that has persisted for at least 6 weeks.

Not a fit: Patients with clinical evidence of VLU infection or those unable to comply with compression therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from hard-to-heal venous leg ulcers.

How similar studies have performed: Previous studies have shown promising results for PICO treatment in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Aire-sur-la-Lys and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous InsufficiencyVenous Leg UlcerNegative Pressure Wound TherapyNPWHard-to-Heal Venous Leg UlcerCommunity Care
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.