TerminatedNot Applicable

Electrostimulation System WoundEL for Leg Ulcers Healing (

Stopped: Premature termination due to recruitment difficulties

France22 participantsStarted 2021-03-16

Plain-language summary

Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing. Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of healed-leg ulcers

Timeframe: At week 8

Trial details

NCT IDNCT04980898

SponsorCEN Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-17