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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Synartis
  Aire-sur-la-Lys, France Recruiting
• Polyclinique de Picardie
  Amiens, France Recruiting
• Cabinet Privé
  Antibes, France Recruiting
• Clinique d'Argonay
  Argonay, France Recruiting
• Cabinet de Médecine Vasculaire - Angiologie
  Arignac, France Recruiting
• Clinique Rhône Durance
  Avignon, France Recruiting

Study contacts

• Study coordinator: Wassila Drareni
• Email: wassila.drareni@groupecen.com
• Phone: +33 0380680511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.