NCT04980898

Electrostimulation System WoundEL for Leg Ulcers Healing (

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: CEN Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leg Ulcer
• Electrical Remodeling

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2021-07-28
• Last updated: 2025-08-06

Locations

1 site across 1 country: France