PICO Venous Leg Ulcers (VLU) Reimbursement Study

NCT06510777 | Terminated DMC

• 2 other identifiers: PICO.2021.092023-A01760-45
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 44

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.

Conditions

Venous Leg Ulcer; Venous Insufficiency

Keywords

Venous Leg Ulcer; Negative Pressure Wound Therapy; NPW; Hard-to-Heal Venous Leg Ulcer; Community Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time to Achieve Wound Healing

  Up to 12 Weeks

• Relative Wound Area Reduction (RWAR)

  Day 0, Week 4, Week 8, Week 12 (up to 14 weeks ±3days)

• Time to achieve 100% healthy granulation tissue

  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 )

  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

  Day 0 to Week 12 (up to 14 weeks ±3 days)

Other Outcomes (1)

• Cost-Effectiveness Analysis of VLU-Treatment in Community Setting

  Day 0 to Week 12 (up to 14 weeks ±3 days)

Study Arms (2)

PICO Treatment Arm

EXPERIMENTAL

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.

Device: PICO Treatment; Device: Standard of Care (SOC) Treatment

Standard of Care Treatment Arm

ACTIVE COMPARATOR

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.

Device: Standard of Care (SOC) Treatment

Interventions

Standard of Care (SOC) Treatment DEVICE

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.

Also known as: Traditional wound dressings in addition to compression therapy.

PICO Treatment Arm; Standard of Care Treatment Arm

PICO Treatment DEVICE

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.

Also known as: Single-Use Negative Pressure Therapy System PICO 7 (sNPWT)

PICO Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead
• T.J. Smith and Nephew, Limited: collaborator
• CEN Biotech: collaborator

Study Sites (44)

Clinique de L'Atlantique

Puilboreau, France, France

Location

Cabinet Médical

Vandœuvre-lès-Nancy, France, France

Location

Synartis

Aire-sur-la-Lys, France

Location

Polyclinique de Picardie

Amiens, France

Location

Cabinet Privé

Antibes, France

Location

Clinique d'Argonay

Argonay, France

Location

Cabinet de Médecine Vasculaire - Angiologie

Arignac, France

Location

Clinique Rhône Durance

Avignon, France

Location

Cabinet Médical

Béziers, France

Location

Cabinet de Médecine Vasculaire

Bourg-en-Bresse, France

Location

Cabinet Médical

Cahors, France

Location

GCS Pôle Santé de Cahors

Cahors, France

Location

Cicadom

Challes-les-Eaux, France

Location

Sui'vui Santé

Château-Renault, France

Location

Cabinet Médical Gambetta Paymal (CMPG)

Clichy, France

Location

CICA+

Dardilly, France

Location

Maison de Santé d'Etauliers

Étauliers, France

Location

Cicadom

Guilherand-Granges, France

Location

Cabinet Privé

Idron, France

Location

Clinique St. Charles

La Roche-sur-Yon, France

Location

Cabinet Médical

Langon, France

Location

Cicadom

Le Coteau, France

Location

Clinique des Augustines

Malestroit, France

Location

Pôle Santé

Montélimar, France

Location

Cabinet Médical

Paris, France

Location

One Clinic

Plaisir, France

Location

Cabinet d'angiologie de Pont-l'Abbé

Pont-l'Abbé, France

Location

Cabinet privé

Pontcharra, France

Location

Cabinet Privé

Rambouillet, France

Location

Centre de Médecine Vasculaire

Rodez, France

Location

Cabinet Médical

Saint-Alban, France

Location

Clinique Megival

Saint-Aubin-sur-Scie, France

Location

Clinique Mégival

Saint-Aubin-sur-Scie, France

Location

Cabinet Privé

Saint-Gély-du-Fesc, France

Location

Cicadom

Saint-Nazaire, France

Location

Cabinet d'Angiologie et de Médecine Vasculaire

Saint-Priest, France

Location

Polyclinique de Picardie

Sainte-Maxime, France

Location

Cabinet Privé

Sarreguemines, France

Location

Centre Privé de Consultations Médico-Chirurgicales

Saumur, France

Location

Cabinet Privé Soyaux

Soyaux, France

Location

Cabinet Médical

Thionville, France

Location

Clinique Pasteur

Toulouse, France

Location

Centre Léon Blum

Villeurbanne, France

Location

Cabinet Médical

Wattignies, France

Location

MeSH Terms

Conditions

Venous Insufficiency; Varicose Ulcer

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fleur Derdeyn

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary endpoint (i.e., 100% epithelialization) includes a blind assessment to reduce bias. The Blind Assessment Board will assess the primary endpoint using subject-series of wound photos, being unaware of treatment allocation of subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: December 29, 2023
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (44)