PICO Venous Leg Ulcers (VLU) Reimbursement Study

NASuspendedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

December 29, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Venous InsufficiencyVenous Leg Ulcer
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (44)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CEN Biotech

INDUSTRY

collaborator

T.J. Smith and Nephew, Limited

UNKNOWN

lead

Smith & Nephew, Inc.

INDUSTRY

NCT06510777 - PICO Venous Leg Ulcers (VLU) Reimbursement Study | Biotech Hunter | Biotech Hunter