294
Participants
Start Date
December 29, 2023
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
PICO Treatment
"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) Treatment
"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)~3. Application of appropriate venous compression therapy based on Ankle Brachial Pressure Index (ABPI) value."
Clinique de L'Atlantique, Puilboreau
Cabinet Médical, Vandœuvre-lès-Nancy
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
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
Centre Léon Blum, Villeurbanne
Cabinet Médical, Wattignies
Collaborators (1)
CEN Biotech
INDUSTRY
T.J. Smith and Nephew, Limited
UNKNOWN
Smith & Nephew, Inc.
INDUSTRY