Electrostimulation System WoundEL for Leg Ulcers Healing (

Last updated: August 4, 2025
Sponsor: CEN Biotech
Overall Status: Terminated

Phase

N/A

Condition

Venous Leg Ulcers

Ulcers

Treatment

Standard cares

WoundEL medical device

Clinical Study ID

NCT04980898
C1633
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Venous leg ulcer evolving for at least 3 months, the area of which is between 4 cm²and 200 cm² and the smallest axis of which is less than 10 cm and the largest axisless than 20 cm;

  • Have a Systolic Pressure Index (IPS) at the ankle between 0.89 and 1.3 and / or asystolic 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 Dopplerecho 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

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

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Standard cares
Phase:
Study Start date:
March 16, 2021
Estimated Completion Date:
November 17, 2023

Study 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.

Connect with a study center

  • Centre Hospitalier Du Mans

    Le Mans, 72037
    France

    Site Not Available

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