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Electrostimulation System WoundEL for Leg Ulcers Healing (

NCT04980898 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

  • Leg Ulcer
  • Electrical Remodeling

Interventions

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

Sponsors & Collaborators

  • WoundEL Health Care

    collaborator UNKNOWN

  • CEN Biotech

    lead INDUSTRY

Principal Investigators

  • HERVE MAILLARD, MD · Centre Hospitalier du Mans

  • LAURE-CECILE MARTIN · WoundEL Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2023-11-17
Completion
2023-11-17

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980898 on ClinicalTrials.gov