Status:
TERMINATED
PICO Venous Leg Ulcers (VLU) Reimbursement Study
Lead Sponsor:
Smith & Nephew, Inc.
Collaborating Sponsors:
CEN Biotech
T.J. Smith and Nephew, Limited
Conditions:
Venous Insufficiency
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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-bas...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06510777
Start Date
December 29 2023
End Date
October 24 2025
Last Update
January 8 2026
Active Locations (44)
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1
Clinique de L'Atlantique
Puilboreau, France, France
2
Cabinet Médical
Vandœuvre-lès-Nancy, France, France
3
Synartis
Aire-sur-la-Lys, France
4
Polyclinique de Picardie
Amiens, France