PICO Venous Leg Ulcers (VLU) Reimbursement Study

Summary

This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners. The primary endpoint is the incidence of confirmed healed VLUs at 12 weeks or before, in the PICO treatment group versus the SOC group. The study hypothesis is based on the Kirsner study (Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. 2019 Sep;27(5):519-529)), which compared PICO treatment to traditional NPWT (t-NPWT); the ITT analysis in the subgroup of patients with VLU showed 45.1% wound closure (confirmed wound healing) at 12 weeks in the PICO group as compared to 28% in the t-NPWT group, yielding a difference of 17.1%, 95% Confidence Interval = (-1.9%;+35.4%). For our study, the Sponsor made the assumptions that the t-NPWT healing proportion (28%) can be used as conservative estimate for the control group proportion and that the PICO group should provide at least a 17% improvement over standard of care. Adaptative design is chosen to adjust the sample size using the re-assessment size method to preserve alpha risk (α) level.

Conditions

• Venous Insufficiency
• Venous 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.

Sponsors & Collaborators

• CEN Biotech

  collaborator INDUSTRY

• T.J. Smith and Nephew, Limited

  collaborator UNKNOWN

• Smith & Nephew, Inc.

  lead INDUSTRY

Principal Investigators

• Fleur Derdeyn · Smith & Nephew, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-29

Primary Completion

2025-10-24

Completion

2025-10-24

Countries

• France

Study Locations