Electrostimulation System WoundEL for Leg Ulcers Healing (

CEN Biotech22 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Leg Ulcer Electrical Remodeling

Interventions

WoundEL medical deviceDEVICE

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.

Standard caresOTHER

Cleaning and monitoring

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Du Mans

Le Mans, France

Outcomes

Primary Outcomes

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.

Time frame: At week 8

Secondary Outcomes

Assessing the leg ulcer-related pain

Visual Analogic Scale

Time frame: At weeks 0,2, 4, 6, 8

Assessing the analgesic consumption

Patient reported-consumption of painkillers

Time frame: At weeks 0,2, 4, 6, 8

Assessing the quality of life

EuroQol (EQ5-D) questionnaire

Time frame: At weeks 0,2, 4, 6, 8

Assessing the leg ulcer healing stage

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

Time frame: At weeks 0,2, 4, 6, 8, 10

WoundEL system security

Adverse reactions, dysfunctions

Time frame: At weeks 0,2, 4, 6, 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.