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.
This is a national, multicentre, pragmatic, randomized, controlled superiority study in which PICO treatment with compression therapy will be compared against Standard of Care (i.e. traditional wound dressings with compression therapy). There will be two parallel treatment arms with a 1:1 allocation ratio and a stratification on wound duration and size. There will be an additional blind assessment for the primary outcome measure. Approximately 37 investigational sites located in France will be enrolled. At each site, a community-based practitioner (general practitioner or specialist) will be enrolled as Principal Investigator (PI). District nurses will be responsible for providing wound care in homecare setting. Duly informed and eligible patients will complete an inclusion visit after which they will enter in a 2-week run-in period in which subjects will be treated with standard of care. After these 2 weeks of run-in, eligibility to randomization will be assessed using pre-specified criteria listed in the protocol, that aim to confirm that the wound does not respond to an adequately conducted standard of care in a satisfactory manner, including subject compliance with compression therapy. Upon randomization, baseline data will be collected, and each subject will be followed-up by the PI for 12 weeks. The PI will conduct 3 visits, i.e., at Week 4 (D28±3 days), Week 8 (D56±3 days), and Week 12 (D84±3 days). Relevant study data will be collected at these visits. In the event wound healing is observed during the 12-week follow-up period of the study either by the PI or by the home care nurse, a Wound Healing Confirmation Visit needs to be conducted with the PI 2 weeks later (±3 days) to confirm that the wound is still healed. Only wounds still healed at the wound healing confirmation visit will be counted as "healed" in the primary endpoint analysis. This means that for wounds that are not healed by Week 12, the visit with the PI at Week 12 will be the final study visit for the subject. Following, because a Wound Healing Confirmation Visit needs to be conducted 2 weeks (±3 days) following the initial observation of wound healing, which can occur at any time throughout the 12 week follow-up period, the Wound Healing Confirmation Visit can occur at any time as well, but at the latest 2 weeks (±3 days) following the visit at Week 12, i.e. at week 14±3 days. In between study visits with the PI, patients are cared for at home by their home care nurse who will also be trained on the study. The study nurse will be collecting study related data as well using a secure mobile application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
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.
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, France, France
Cabinet Médical
Vandœuvre-lès-Nancy, France, France
Synartis
Aire-sur-la-Lys, France
Polyclinique de Picardie
Amiens, France
Cabinet Privé
Antibes, France
Clinique d'Argonay
Argonay, France
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.
Time frame: Up to 12 weeks
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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to Week 12 (up to 14 weeks ±3 days)
Number of Adverse Events
Number of participants with an adverse event
Time frame: Day 0 to Week 12 (up to 14 weeks ±3 days)
Number of device deficiencies
Number of participants with a device deficiency
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Week 12 (up to 14 weeks ±3 days)
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Cabinet de Médecine Vasculaire - Angiologie
Arignac, France
Clinique Rhône Durance
Avignon, France
Cabinet Médical
Béziers, France
Cabinet de Médecine Vasculaire
Bourg-en-Bresse, France
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