Clinical trial NCT04980898: Electrostimulation System WoundEL for Leg Ulcers Healing (
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Ulcer
Electrical Remodeling
Keywords: WoundEL
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: WoundEL Health Care
First posted: 2021-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of healed-leg ulcers
timeFrame: At week 8
Secondary outcomes:
measure: Assessing the leg ulcer-related pain
timeFrame: At weeks 0,2, 4, 6, 8
measure: Assessing the analgesic consumption
timeFrame: At weeks 0,2, 4, 6, 8
measure: Assessing the quality of life
timeFrame: At weeks 0,2, 4, 6, 8
measure: Assessing the leg ulcer healing stage
timeFrame: At weeks 0,2, 4, 6, 8, 10
measure: WoundEL system security
timeFrame: At weeks 0,2, 4, 6, 8
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
affiliation: Centre Hospitalier du Mans
name: HERVE MAILLARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: WoundEL Health Care
name: LAURE-CECILE MARTIN
role: STUDY_DIRECTOR
References: