PICO Venous Leg Ulcers (VLU) Reimbursement Study

NCT ID: NCT06510777

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-29
• Study Completion Date: 2025-10-24

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.

Conditions

Venous Insufficiency; Venous Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PICO Treatment Arm

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.

Group Type: EXPERIMENTAL

PICO Treatment

Intervention Type: 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.

Standard of Care (SOC) Treatment

Intervention Type: 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.

Standard of Care Treatment Arm

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC) Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Single-Use Negative Pressure Therapy System PICO 7 (sNPWT); Traditional wound dressings in addition to compression therapy.

Eligibility Criteria

Inclusion Criteria

• 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
• The subject is affiliated to a French Health insurance scheme

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEN Biotech

INDUSTRY

Sponsor Role: collaborator

T.J. Smith and Nephew, Limited

UNKNOWN

Sponsor Role: collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fleur Derdeyn

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

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

Cabinet de Médecine Vasculaire - Angiologie

Arignac, , France

Clinique Rhône Durance

Avignon, , France

Cabinet Médical

Béziers, , France

Cabinet de Médecine Vasculaire

Bourg-en-Bresse, , France

Cabinet Médical

Cahors, , France

GCS Pôle Santé de Cahors

Cahors, , France

Cicadom

Challes-les-Eaux, , France

Sui'vui Santé

Château-Renault, , France

Cabinet Médical Gambetta Paymal (CMPG)

Clichy, , France

CICA+

Dardilly, , France

Maison de Santé d'Etauliers

Étauliers, , France

Cicadom

Guilherand-Granges, , France

Cabinet Privé

Idron, , France

Clinique St. Charles

La Roche-sur-Yon, , France

Cabinet Médical

Langon, , France

Cicadom

Le Coteau, , France

Clinique des Augustines

Malestroit, , France

Pôle Santé

Montélimar, , France

Cabinet Médical

Paris, , France

One Clinic

Plaisir, , France

Cabinet d'angiologie de Pont-l'Abbé

Pont-l'Abbé, , France

Cabinet privé

Pontcharra, , France

Cabinet Privé

Rambouillet, , France

Centre de Médecine Vasculaire

Rodez, , France

Cabinet Médical

Saint-Alban, , France

Clinique Megival

Saint-Aubin-sur-Scie, , France

Clinique Mégival

Saint-Aubin-sur-Scie, , France

Cabinet Privé

Saint-Gély-du-Fesc, , France

Cicadom

Saint-Nazaire, , France

Cabinet d'Angiologie et de Médecine Vasculaire

Saint-Priest, , France

Polyclinique de Picardie

Sainte-Maxime, , France

Cabinet Privé

Sarreguemines, , France

Centre Privé de Consultations Médico-Chirurgicales

Saumur, , France

Cabinet Privé Soyaux

Soyaux, , France

Cabinet Médical

Thionville, , France

Clinique Pasteur

Toulouse, , France

Centre Léon Blum

Villeurbanne, , France

Cabinet Médical

Wattignies, , France

Countries

France

Other Identifiers

2023-A01760-45

Identifier Type: OTHER

Identifier Source: secondary_id

PICO.2021.09

Identifier Type: -

Identifier Source: org_study_id