PICO Venous Leg Ulcers (VLU) Reimbursement Study
- Conditions
- Venous InsufficiencyVenous Leg Ulcer
- Interventions
- Device: Standard of Care (SOC) TreatmentDevice: PICO Treatment
- Registration Number
- NCT06510777
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 294
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Subject signed informed consent
-
Both gender adult ≥ 18 years old
-
Venous leg ulcer (VLU) diagnosed by:
-
ABPI ≥ 0.7 and < 1.3 within the last 3 months
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If ABPI < 1.3, one of the following measures should be available:
- Toe Brachial Pressure Index (TBPI) > 0.7
- Toe pressure (TP) > 50 mmHg
- Transcutaneous oxygen pressure (TcPO2) > 30 mmHg
-
-
VLU duration ≥ 6 weeks
-
VLU surface area:
- Isolated leg ulcer: ≤ 100 cm^2
- Non-isolated leg ulcers: pooled surface area ≤ 100 cm^2 that can be covered by a single dressing
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Exuding VLU according to clinical judgement
-
The subject is in acceptable state of health and nutrition according to clinical judgement
-
The subject is able to follow the protocol instruction and willing to comply with compression therapy
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The subject is affiliated to a French Health insurance scheme
- Clinical evidence of VLU infection [i.e. presence of at least 3 overt signs of local infection (e.g., erythema, warmth, swelling, pain, odor) or signs of spreading or systemic infection)
- Wound with necrotic tissue after debridement
- Sloughy wound (100% of slough) after debridement
- Exposed arteries, veins, nerves or organs
- Current therapy with chronic oral corticosteroids (>10 days)
- Previous therapy with negative pressure wound therapy device or hyperbaric oxygen within 7 days prior to enrolment
- Arterial insufficiency non-revascularized
- Wound actively bleeding
- Malignant wound
- Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial
- Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision cannot take part in clinical investigations) and 68 (patients in emergency situation) of the Medical Device Regulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Treatment Arm Standard of Care (SOC) Treatment Wounds are treated with appropriate traditional dressings throughout the study based on wound condition and healing trajectory. Wound care treatment at home will be done by home care nurses. Compression therapy will be maintained throughout the entire patient's follow-up. PICO Treatment Arm Standard of Care (SOC) Treatment The maximum duration for treatment with PICO will be 12 weeks. PICO treatment will be discontinued if the wound does not respond to treatment after 2 weeks according to predefined criteria, if the wound gets worse at any time, if the wound is 100% epithelialized, or if the wound presents advanced healing, which will be assessed using predefined criteria. In the latter case where the VLU is determined sufficiently healed according to the pre-specified criteria in the protocol, subjects will be switched to Standard of Care (SOC). Wound care treatment at home will be done by home care nurses. Compression therapy will be maintained throughout the entire patient's follow-up. PICO Treatment Arm PICO Treatment The maximum duration for treatment with PICO will be 12 weeks. PICO treatment will be discontinued if the wound does not respond to treatment after 2 weeks according to predefined criteria, if the wound gets worse at any time, if the wound is 100% epithelialized, or if the wound presents advanced healing, which will be assessed using predefined criteria. In the latter case where the VLU is determined sufficiently healed according to the pre-specified criteria in the protocol, subjects will be switched to Standard of Care (SOC). Wound care treatment at home will be done by home care nurses. Compression therapy will be maintained throughout the entire patient's follow-up.
- Primary Outcome Measures
Name Time Method Number of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks Up to 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.
- Secondary Outcome Measures
Name Time Method Number of Adverse Events Day 0 to Week 12 (up to 14 weeks ±3 days) Number of participants with an adverse event
Subject satisfaction assessed using a 5 point-Likert scale questionnaire Week 12 (up to 14 weeks ±3 days) 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 to Achieve Wound Healing Up to 12 Weeks Number of days required from baseline to achieve wound healing where the wound is observed with complete closure (100% epithelialization).
Changes in quality of life using the disease specific VEINES-Qol (Venous Insufficiency Epidemiological and Economic Study on Quality of Life) questionnaire Day 0 to Week 12 (up to 14 weeks ±3 days) 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.Visual Analog Scale (VAS) score at dressing removal (PICO Treatment Arm only) Day 0 to Week 12 (up to 14 weeks±3 days) 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.
Relative Wound Area Reduction (RWAR) Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3days) 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 to achieve 100% healthy granulation tissue Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3 days) Number of days required to achieve 100% granulation over 12 weeks
VLU treatment impact on mobility and physical activity using a 5 point-Likert scale Week 4, Week 8, Week 12 (up to 14 weeks±3 days) 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)
Changes in quality of life using the generic EuroQol 5 Dimension (EQ-5D-5L ) Day 0 to Week 12 (up to 14 weeks ±3 days) 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.Number of device deficiencies Day 0 to Week 12 (up to 14 weeks ±3 days) Number of participants with a device deficiency
Healthcare Practitioner (HCP) satisfaction assessed using a 5 point-Likert scale questionnaire Week 12 (up to 14 weeks±3 days) 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)
Trial Locations
- Locations (29)
Cabinet de Médecine Vasculaire - Angiologie
🇫🇷Arignac, France
Synartis
🇫🇷Aire-sur-la-Lys, France
Cabinet Privé
🇫🇷Sarreguemines, France
Cabinet Médical
🇫🇷Wattignies, France
Polyclinique de Picardie
🇫🇷Sainte-Maxime, France
Clinique d'Argonay
🇫🇷Argonay, France
Clinique Rhône Durance
🇫🇷Avignon, France
Cabinet de Médecine Vasculaire
🇫🇷Bourg-en-Bresse, France
GCS Pôle Santé de Cahors
🇫🇷Cahors, France
Cicadom
🇫🇷Saint-Nazaire, France
Sui'vui Santé
🇫🇷Château-Renault, France
Cabinet Médical Gambetta Paymal (CMPG)
🇫🇷Clichy, France
CICA+
🇫🇷Dardilly, France
Maison de Santé d'Etauliers
🇫🇷Etauliers, France
Clinique St. Charles
🇫🇷La Roche-sur-Yon, France
Clinique des Augustines
🇫🇷Malestroit, France
Pôle Santé
🇫🇷Montélimar, France
One Clinic
🇫🇷Plaisir, France
Cabinet d'angiologie de Pont-l'Abbé
🇫🇷Pont-l'Abbé, France
Cabinet privé
🇫🇷Pontcharra, France
Clinique de L'Atlantique
🇫🇷Puilboreau, France
Centre de Médecine Vasculaire
🇫🇷Rodez, 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
Centre Privé de Consultations Médico-Chirurgicales
🇫🇷Saumur, France
Cabinet Privé Soyaux
🇫🇷Soyaux, France
Clinique Pasteur
🇫🇷Toulouse, France
Centre Léon Blum
🇫🇷Villeurbanne, France