Electrostimulation System WoundEL for Leg Ulcers Healing (

NCT04980898 | Terminated

• 1 other identifier: C1633
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

WoundEL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessing the leg ulcer-related pain

  At weeks 0,2, 4, 6, 8

• Assessing the analgesic consumption

  At weeks 0,2, 4, 6, 8

• Assessing the quality of life

  At weeks 0,2, 4, 6, 8

• Assessing the leg ulcer healing stage

  At weeks 0,2, 4, 6, 8, 10

• WoundEL system security

  At weeks 0,2, 4, 6, 8

Study Arms (2)

Electrical stimulation wound management system

EXPERIMENTAL

Two daily electrostimulation sessions using the WoundEL® device on wound two for 30 minutes at an adjustable intensity, between 5 and 42 milliampere and chosen by the patient.

Device: WoundEL medical device; Other: Standard cares

Standard of care

ACTIVE COMPARATOR

Use of dressings appropriate to the stage of healing according to French recommendations for the management of leg ulcers.

Other: Standard cares

Interventions

WoundEL medical device 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.

Electrical stimulation wound management system

Standard cares OTHER

Cleaning and monitoring

Electrical stimulation wound management system; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CEN Biotech: lead
• WoundEL Health Care: collaborator

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72037, France

Location

MeSH Terms

Conditions

Leg Ulcer; Atrial Remodeling

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• HERVE MAILLARD, MD

  Centre Hospitalier du Mans

  PRINCIPAL INVESTIGATOR

• LAURE-CECILE MARTIN

  WoundEL Health Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The third blind person will have photographs of the wound at 10 weeks and all the surface readings on tracing paper necessary for the automated calculation of the surface with specific software. Readings will be sent in random order and third parties will not know the treatment, patient or date of the reading.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 28, 2021
• Study Start: March 16, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)