PICO Venous Leg Ulcers (VLU) Reimbursement Study

Launched by SMITH & NEPHEW, INC. · Jul 15, 2024

Keywords

ClinConnect Summary

The PICO Venous Leg Ulcers (VLU) Reimbursement Study is looking at a new treatment method called PICO for patients with hard-to-heal venous leg ulcers. This study aims to find out if using PICO for up to 12 weeks is better than the usual standard treatment. The main goal is to see how many patients have fully healed ulcers after 12 weeks. Previous research showed that PICO treatment helped more patients heal compared to traditional methods, and this study hopes to confirm those findings.

To participate, you must be at least 18 years old and have a diagnosed venous leg ulcer that has lasted for at least six weeks. Your ulcer should meet specific size and health criteria, and you need to be in generally good health. If you join the study, you’ll receive either the PICO treatment or the standard treatment for your ulcer, and you'll be monitored closely to track your healing progress. This trial is currently seeking participants, so if you or someone you know might be eligible, it’s worth considering!

Gender

ALL

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