Electrostimulation System WoundEL for Leg Ulcers Healing (

Launched by CEN BIOTECH · Jul 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new device called WoundEL® that uses electrical stimulation to help heal leg ulcers. Leg ulcers are painful sores that can take a long time to heal, especially if they have been present for more than three months. The WoundEL® device aims to mimic the body's natural electric field to encourage skin cells to grow and repair the wound. Researchers want to see if this device works better than the standard treatments currently used in France.

To participate in this trial, individuals should be between 65 and 74 years old and have a specific type of leg ulcer that meets certain size and health criteria. They must also be willing to wear compression stockings, which help improve blood flow. Participants will receive treatment with the WoundEL® device and will be monitored closely throughout the study. It's important to note that those with untreated infections, certain types of ulcers, or specific health conditions may not be eligible to join. This trial is a step towards finding new and effective ways to help heal leg ulcers for those who need it most.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Venous leg ulcer evolving for at least 3 months, the area of which is between 4 cm² and 200 cm² and the smallest axis of which is less than 10 cm and the largest axis less than 20 cm;
• • Have a Systolic Pressure Index (IPS) at the ankle between 0.89 and 1.3 and / or a systolic pressure measurement at the big toe greater than or equal to 60 mmHg;
• • Accept the port of venous compression;
• • Presenting superficial and / or deep venous insufficiency, documented on a Doppler echo dating less than one year;
• • affiliated to a social security scheme or beneficiary of such a scheme;
• • Having given their free, informed and written consent.
• Exclusion Criteria:
• • Untreated infected wound;
• • Cancerous ulcer;
• • Treated with systemic corticosteroids or chemotherapy;
• • for which a skin graft is necessary;
• • Contraindications for the treatment of leg ulcers with the WoundEL system;
• • Pregnant or lactating women;
• • Vulnerable people or under legal/judicial protection