Electrostimulation System WoundEL for Leg Ulcers Healing (

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2023-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers

NCT01022216

Wound Healing

COMPLETED PHASE2

Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

NCT00399308

Leg Ulcer Varicose Ulcer

COMPLETED PHASE1/PHASE2

Tissue Repair Gel in Venous Leg Ulcers (US)

NCT06707090

Venous Leg Ulcer Venous Ulcer Venous Stasis Ulcer +5 more

RECRUITING PHASE3

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

NCT01656889

Venous Leg Ulcers

COMPLETED PHASE3

Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.

NCT04687839

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Leg Ulcer Electrical Remodeling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Electrical stimulation wound management system

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.

Group Type EXPERIMENTAL

WoundEL medical device

Intervention Type 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.

Standard cares

Intervention Type OTHER

Cleaning and monitoring

Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard cares

Intervention Type OTHER

Cleaning and monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Standard cares

Cleaning and monitoring

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No