Back to results

Electrostimulation System WoundEL for Leg Ulcers Healing ( (ELEXICA)

Primary Purpose

Leg Ulcer, Electrical Remodeling

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

WoundEL medical device

Standard cares

About this trial

This is an interventional treatment trial for Leg Ulcer focused on measuring WoundEL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier Du MansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical stimulation wound management system

Standard of care

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessing the leg ulcer-related pain

Visual Analogic Scale

Assessing the analgesic consumption

Patient reported-consumption of painkillers

Assessing the quality of life

EuroQol (EQ5-D) questionnaire

Assessing the leg ulcer healing stage

Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue

WoundEL system security

Adverse reactions, dysfunctions

Full Information

NCT ID

NCT04980898

First Posted

July 21, 2021

Last Updated

March 1, 2023

Sponsor

CEN Biotech

Collaborators

WoundEL Health Care

1. Study Identification

Unique Protocol Identification Number

NCT04980898

Brief Title

Electrostimulation System WoundEL for Leg Ulcers Healing (

Acronym

ELEXICA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 16, 2021 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CEN Biotech

Collaborators

WoundEL Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leg Ulcer, Electrical Remodeling

Keywords

WoundEL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric

Masking

Outcomes Assessor

Masking Description

The third blind person will have photographs of the wound at 10 weeks and all the surface readings on tracing paper necessary for the automated calculation of the surface with specific software. Readings will be sent in random order and third parties will not know the treatment, patient or date of the reading.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrical stimulation wound management system

Arm Type

Experimental

Arm 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.

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

WoundEL medical device

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard cares

Intervention Description

Cleaning and monitoring

Primary Outcome Measure Information:

Title

Rate of healed-leg ulcers

Description

Time Frame

At week 8

Secondary Outcome Measure Information:

Title

Assessing the leg ulcer-related pain

Description

Visual Analogic Scale

Time Frame

At weeks 0,2, 4, 6, 8

Title

Assessing the analgesic consumption

Description

Patient reported-consumption of painkillers

Time Frame

At weeks 0,2, 4, 6, 8

Title

Assessing the quality of life

Description

EuroQol (EQ5-D) questionnaire

Time Frame

At weeks 0,2, 4, 6, 8

Title

Assessing the leg ulcer healing stage

Description

Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue

Time Frame

At weeks 0,2, 4, 6, 8, 10

Title

WoundEL system security

Description

Adverse reactions, dysfunctions

Time Frame

At weeks 0,2, 4, 6, 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnaud TERRILLON-SEYTRE

Phone

+330380682093

arnaud.terrillonseytre@groupecen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HERVE MAILLARD, MD

Organizational Affiliation

Centre Hospitalier du Mans

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

LAURE-CECILE MARTIN

Organizational Affiliation

WoundEL Health Care

Official's Role

Study Director

Facility Information:

Facility Name

Centre Hospitalier Du Mans

City

Le Mans

ZIP/Postal Code

72037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HERVE MAILLARD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Electrostimulation System WoundEL for Leg Ulcers Healing (

We'll reach out to this number within 24 hrs