Leg Ulcer, Electrical Remodeling
Conditions
Keywords
WoundEL
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.
Interventions
DEVICEWoundEL 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.
OTHERStandard cares
Cleaning and monitoring
Sponsors
WoundEL Health Care
CEN Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Superiority randomized controlled study, open label with blinded primary outcome assessor, multicentric
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of healed-leg ulcers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the leg ulcer-related pain | At weeks 0,2, 4, 6, 8 | Visual Analogic Scale |
| Assessing the analgesic consumption | At weeks 0,2, 4, 6, 8 | Patient reported-consumption of painkillers |
| Assessing the quality of life | At weeks 0,2, 4, 6, 8 | EuroQol (EQ5-D) questionnaire |
| Assessing the leg ulcer healing stage | At weeks 0,2, 4, 6, 8, 10 | Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue |
| WoundEL system security | At weeks 0,2, 4, 6, 8 | Adverse reactions, dysfunctions |
Countries
France
Outcome results
None listed