Electrostimulation System WoundEL for Leg Ulcers Healing ( (ELEXICA)

CEN Biotech

Status: Enrolling

Conditions: Electrical Remodeling; Leg Ulcer

Treatments: Device: WoundEL medical device; Other: Standard cares

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04980898

C1633

Details and patient eligibility

About

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.

Full description

Patients with a leg ulcer will be randomized to the "usual treatment" or "WoundEL" group.

The progress of the leg ulcer will be monitored every 2 weeks for 8 weeks or sooner if wound healing occurs. All leg ulcers will be examined at 10 weeks to check for healing or the condition of the leg ulcer if it has not healed. A third-blind party will also assess the ulcer condition at 10 weeks, based on standardized photographs.

The consumption of analgesics, pain and quality of life will be compared in the 2 groups.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Electrical stimulation wound management system

Experimental group

Description:

Two daily electrostimulation sessions using the WoundEL® device on wound two for 30 minutes at an adjustable intensity, between 5 and 42 milliampere and chosen by the patient.

Treatment:

Other: Standard cares

Device: WoundEL medical device

Standard of care

Active Comparator group

Description:

Use of dressings appropriate to the stage of healing according to French recommendations for the management of leg ulcers.

Treatment:

Other: Standard cares