Electrostimulation System WoundEL for Leg Ulcers Healing ( (ELEXICA)

Randomized, Third-blind, Controlled Trial of Superiority (Versus Sequential Dressings Recommended by the HAS) of an Electrode Dressing (WoundEL® Electrostimulation Device) on the Healing of Venous Ulcers

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.

Study Overview

• Status: Recruiting
• Conditions: Leg Ulcer; Electrical Remodeling
• Intervention / Treatment: Device: WoundEL medical device; Other: Standard cares

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud TERRILLON-SEYTRE; Phone Number: +330380682093; Email: arnaud.terrillonseytre@groupecen.com

Study Locations

• France
  • Le Mans, France, 72037
    • Recruiting
    • Centre Hospitalier Du Mans
    • Contact: HERVE MAILLARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical stimulation wound management system; 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.	Device: WoundEL medical device; The WoundEl system is composed by: a class IIa device , a class IIb dressing electrode and a class I disperser electrode. Applied to the leg ulcer, WoundEL® reproduces the endogenous electrical current to stimulate all the factors contributing to healing. Electrical current is evenly spread over the Dressing Electrode which also maintains a moist wound healing environment.; Other: Standard cares; Cleaning and monitoring
Active Comparator: Standard of care; Use of dressings appropriate to the stage of healing according to French recommendations for the management of leg ulcers.	Other: Standard cares; Cleaning and monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of healed-leg ulcers	Complete wound-healing correspond to 100% epithelialization of the leg ulcer, without persistent erosion or crusting. Complete healing of ulcers will be observed by the investigator and assessed by a third-blind.	At week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the leg ulcer-related pain	Visual Analogic Scale	At weeks 0,2, 4, 6, 8
Assessing the analgesic consumption	Patient reported-consumption of painkillers	At weeks 0,2, 4, 6, 8
Assessing the quality of life	EuroQol (EQ5-D) questionnaire	At weeks 0,2, 4, 6, 8
Assessing the leg ulcer healing stage	Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue	At weeks 0,2, 4, 6, 8, 10
WoundEL system security	Adverse reactions, dysfunctions	At weeks 0,2, 4, 6, 8

Collaborators and Investigators

• Sponsor: CEN Biotech
• Collaborators: WoundEL Health Care
• Investigators: Principal Investigator: HERVE MAILLARD, MD, Centre Hospitalier Du Mans; Study Director: LAURE-CECILE MARTIN, WoundEL Health Care

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: WoundEL
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Pathological Conditions, Anatomical; Ulcer; Leg Ulcer; Atrial Remodeling
• Other Study ID Numbers: C1633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No