Electrostimulation System WoundEL for Leg Ulcers Healing (

Leg Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980898
• Other study ID #: C1633
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: CEN Biotech
• Contact: Arnaud TERRILLON-SEYTRE
• Phone: +330380682093
• Email: arnaud.terrillonseytre[@]groupecen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Remodeling
• Electrical Remodeling
• Leg Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
CEN Biotech	WoundEL Health Care

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessing the leg ulcer-related pain	Visual Analogic Scale	At weeks 0,2, 4, 6, 8
Secondary	Assessing the analgesic consumption	Patient reported-consumption of painkillers	At weeks 0,2, 4, 6, 8
Secondary	Assessing the quality of life	EuroQol (EQ5-D) questionnaire	At weeks 0,2, 4, 6, 8
Secondary	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
Secondary	WoundEL system security	Adverse reactions, dysfunctions	At weeks 0,2, 4, 6, 8