Leg UlcerELEXICANCT04980898
Electrostimulation System WoundEL for Leg Ulcers Healing (
A study testing WoundEL medical device in people with Leg Ulcer and Electrical Remodeling, run by CEN Biotech at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer, Electrical Remodeling
- What is being tested?
- WoundEL medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2021to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- WoundEL medical device, Standard cares
- Keywords
- WoundEL
- Medical subject headings
- Leg Ulcer, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WoundEL medical deviceDevice
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 caresOther
Cleaning and monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard cares |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 8
Secondary outcomes (5)
Assessing the leg ulcer-related pain
Visual Analogic Scale
Measured: At weeks 0,2, 4, 6, 8
Assessing the analgesic consumption
Patient reported-consumption of painkillers
Measured: At weeks 0,2, 4, 6, 8
Assessing the quality of life
EuroQol (EQ5-D) questionnaire
Measured: At weeks 0,2, 4, 6, 8
Assessing the leg ulcer healing stage
Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue
Measured: At weeks 0,2, 4, 6, 8, 10
WoundEL system security
Adverse reactions, dysfunctions
Measured: At weeks 0,2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start16 Mar 2021
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Premature termination due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WoundEL Health Care
- Responsible party
- Sponsor
- Investigators
- HERVE MAILLARD, MD, Principal investigator, Centre Hospitalier du MansLAURE-CECILE MARTIN, Study director, WoundEL Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980898
- Sponsor's protocol ID
- C1633
- Acronym
- ELEXICA
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04980898
- Acronym / sponsor ID
- ELEXICA / C1633
- Conditions
- Leg Ulcer, Electrical Remodeling
- Keywords
- WoundEL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination due to recruitment difficulties
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- WoundEL Health Care
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation wound management system | Experimental | Device: WoundEL medical device, Other: Standard caresTwo 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. |
| Standard of care | Active comparator | Other: Standard caresUse of dressings appropriate to the stage of healing according to French recommendations for the management of leg ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WoundEL medical deviceThe 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. | Device | Electrical stimulation wound management system |
| Standard caresCleaning and monitoring | Other | Electrical stimulation wound management system, Standard of care |
Primary outcome
Rate of healed-leg ulcers
Time frame: At week 8
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.
5 secondary outcomes
Assessing the leg ulcer-related pain
Time frame: At weeks 0,2, 4, 6, 8
Assessing the analgesic consumption
Time frame: At weeks 0,2, 4, 6, 8
Assessing the quality of life
Time frame: At weeks 0,2, 4, 6, 8
Assessing the leg ulcer healing stage
Time frame: At weeks 0,2, 4, 6, 8, 10
WoundEL system security
Time frame: At weeks 0,2, 4, 6, 8
Results and safety
The study was stopped early (reason given: Premature termination due to recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HERVE MAILLARD, MD principal investigator
Centre Hospitalier du Mans
LAURE-CECILE MARTIN study director
WoundEL Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WoundEL medical device in people with Leg Ulcer and Electrical Remodeling, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Premature termination due to recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of healed-leg ulcers (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.