Leg Ulcer Clinical Trial
— ELEXICAOfficial 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
NCT number | NCT04980898 |
Other study ID # | C1633 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 16, 2021 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Du Mans | Le Mans |
Lead Sponsor | Collaborator |
---|---|
CEN Biotech | WoundEL Health Care |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessing the leg ulcer-related pain | Visual Analogic Scale | At weeks 0,2, 4, 6, 8 | |
Secondary | Assessing the analgesic consumption | Patient reported-consumption of painkillers | At weeks 0,2, 4, 6, 8 | |
Secondary | Assessing the quality of life | EuroQol (EQ5-D) questionnaire | At weeks 0,2, 4, 6, 8 | |
Secondary | Assessing the leg ulcer healing stage | Area measurement, periwound skin aspect, local signs of infection, antibiotic rescue | At weeks 0,2, 4, 6, 8, 10 | |
Secondary | WoundEL system security | Adverse reactions, dysfunctions | At weeks 0,2, 4, 6, 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03644849 -
Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
|
N/A | |
Recruiting |
NCT02842502 -
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers
|
N/A | |
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Terminated |
NCT02509533 -
Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method
|
N/A | |
Completed |
NCT00371371 -
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00270972 -
The Evaluation of OrCel for the Treatment of Venous Ulcers
|
N/A | |
Terminated |
NCT01657318 -
Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers
|
||
Completed |
NCT02392390 -
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
|
N/A | |
Not yet recruiting |
NCT06007703 -
Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus
|
||
Recruiting |
NCT02987101 -
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
|
N/A | |
Active, not recruiting |
NCT02973893 -
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
|
Phase 2 | |
Not yet recruiting |
NCT02873728 -
Remote Ischemic Conditioning for Treatment of Chronic Wounds
|
N/A | |
Completed |
NCT01551667 -
Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
|
N/A | |
Completed |
NCT01497210 -
EASH Dressing on Chronic Venous Leg Ulcers
|
Phase 2 | |
Completed |
NCT00235209 -
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
|
Phase 4 | |
Not yet recruiting |
NCT06153589 -
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care
|
N/A | |
Completed |
NCT01591434 -
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
|
Phase 3 | |
Completed |
NCT00838500 -
THERMES ET VEINES: Spa for Prevention of Leg Ulcers
|
Phase 3 | |
Completed |
NCT00243620 -
A Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings
|
N/A |