PICO Venous Leg Ulcers (VLU) Reimbursement Study
NCT Number: NCT06510777
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Venous Insufficiency|Venous Leg Ulcer
Interventions: DEVICE: PICO Treatment|DEVICE: Standard of Care (SOC) Treatment
Sponsor: Smith & Nephew, Inc.
Collaborators: CEN Biotech|T.J. Smith and Nephew, Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 294
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-29
Completion Date: 2025-11-30
Locations: Polyclinique de Picardie, Amiens, France|Cabinet de Médecine Vasculaire - Angiologie, Arignac, France|Clinique Rhône Durance, Avignon, France|Cabinet Médical, Beziers, France|Cabinet de Médecine Vasculaire, Bourg-en-Bresse, France|Cabinet Médical, Cahors, France|GCS Pôle Santé de Cahors, Cahors, France|Cabinet Médical Gambetta Paymal (CMPG), Clichy, France|Maison de Santé d'Etauliers, Etauliers, France|Clinique St. Charles, La Roche-sur-Yon, France|Cabinet Médical, Langon, France|Cabinet Médical, Paris, France|One Clinic, Plaisir, France|Cabinet d'Angiologie, Pontcharra, France|Clinique de L'Atlantique, Puilboreau, France|Cabinet Privé, Rambouillet, France|Centre de Médecine Vasculaire, Rodez, France|Cabinet Médical, Saint Alban, France|Cabinet d'Angiologie et de Médecine Vasculaire, Saint Priest, France|Clinique Megival, Saint-Aubin-sur-Scie, France|Clinique Mégival, Saint-Aubin-sur-Scie, France|Polyclinique de Picardie, Sainte-Maxime, France|Centre Privé de Consultations Médico-Chirurgicales, Saumur, France|Cabinet Privé Soyaux, Soyaux, France|Cabinet Médical, Thionville, France|Clinique Pasteur, Toulouse, France|Cabinet Médical, Vandœuvre-Lès-Nancy, France|Centre Léon Blum, Villeurbanne, France|Cabinet Médical, Wattignies, France

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.

Primary Outcome Measures: Number of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks, The primary endpoint is the incidence of confirmed healed Venous Leg Ulcers (VLUs) at 12 weeks or before in PICO versus SOC group.

A confirmed healed VLU is defined as a wound with complete closure (100% epithelialization) according to PI's judgement during two visits that are two weeks apart (±3 days) AND confirmed by a blind assessment board based on blinded photograph examination., Up to 12 weeks
Secondary Outcome Measures: Time to Achieve Wound Healing, Number of days required from baseline to achieve wound healing where the wound is observed with complete closure (100% epithelialization)., Up to 12 Weeks|Relative Wound Area Reduction (RWAR), Relative wound area reduction (RWAR) at Week 4, Week 8 and at the Final Visit i.e., visit at Week 12 or the Wound Healing Confirmation Visit., Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3days)|Time to achieve 100% healthy granulation tissue, Number of days required to achieve 100% granulation over 12 weeks, Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3 days)|Changes in quality of life using the generic EuroQol 5 Dimension (EQ-5D-5L ), Changes in quality of life from baseline to the final visit (i.e., the visit at Week 12 or the Wound Healing Confirmation Visit).

The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. A higher number is a better outcome., Day 0 to Week 12 (up to 14 weeks ±3 days)|Changes in quality of life using the disease specific VEINES-Qol (Venous Insufficiency Epidemiological and Economic Study on Quality of Life) questionnaire, Changes in quality of life from baseline to the Final Visit (i.e., the visit at Week 12 or the Wound Healing Confirmation Visit).

The VEINES-QOL questionnaire consists of 26 items. It includes questions about symptoms due to Chronic Venous Disorders of the Leg (CVDL) (ten items), limitations in daily activities due to CVDL (nine items) and psychological impact (five items), as well as questions asking about the amount of change in the respondent's leg problem over a 1-year period (one item) and the time of day that the leg problem is most intense (one item).

Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense (question 2), provides only descriptive information and is not scored. High values indicate better outcomes., Day 0 to Week 12 (up to 14 weeks ±3 days)|Number of Adverse Events, Number of participants with an adverse event, Day 0 to Week 12 (up to 14 weeks ±3 days)|Number of device deficiencies, Number of participants with a device deficiency, Day 0 to Week 12 (up to 14 weeks ±3 days)|Visual Analog Scale (VAS) score at dressing removal (PICO Treatment Arm only), Pain scores on removal of the dressing measured using a 0-100 Visual Analog Scale (VAS) score, with zero (0) indicating no pain and 100 indicating the worst possible pain., Day 0 to Week 12 (up to 14 weeks±3 days)|VLU treatment impact on mobility and physical activity using a 5 point-Likert scale, Venous Leg Ulcers (VLU) treatment impact on mobility and physical activity using a 5 point-Likert scale: (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree), Week 4, Week 8, Week 12 (up to 14 weeks±3 days)|Healthcare Practitioner (HCP) satisfaction assessed using a 5 point-Likert scale questionnaire, Analysis of HCP satisfaction with PICO treatment assessed using a 5 point-Likert scale questionnaire (PICO treatment group only): (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree), Week 12 (up to 14 weeks±3 days)|Subject satisfaction assessed using a 5 point-Likert scale questionnaire, Analysis of subject satisfaction with PICO treatment assessed using a 5 point-Likert scale questionnaire (PICO treatment group only): (1) Strongly disagree, (2) Disagree, (3) Neither agree nor disagree, (4) Agree, or (5) Strongly agree), Week 12 (up to 14 weeks ±3 days)
Other Outcome Measures: Cost-Effectiveness Analysis of VLU-Treatment in Community Setting, Comparison of the direct costs estimated from treatment initiation day until the Final Visit (i.e. visit at Week 12 or the Wound Healing Confirmation Visit)., Day 0 to Week 12 (up to 14 weeks ±3 days)