Treatment of venous or venous-arterial lower limb ulcers

An ulcer means a defect involving the skin or subcutaneous tissue, where the depth is often greater than the width of the lesion. It develops in damaged skin, for example in areas of chronic venous insufficiency, as a result of which the tissues cannot be supplied with sufficient nutrients and oxygen.

Most commonly, leg ulcers are chronic, non-healing wounds with abundant exudate requiring frequent dressing changes. They are usually located on the leg, above the ankle, on the front or inner side of the limb.

The healing process of such ulcers is very difficult and prolonged. It requires a great deal of patience from the patient. Unfortunately, frequent treatment failures are due to a lack of perseverance and consistency.

Participation in the clinical trial conducted by the WILMED Medical Center offers patients with non-healing venous ulcers the opportunity to benefit from free, consistent treatment and medical care as well as daily nursing care, which provides a chance to heal these difficult and troublesome wounds. It involves the local application of a medication in the form of a cream containing substances used in the treatment of this type of condition or a cream containing a comparator substance. Throughout the study, all patients will also receive free standard ulcer treatment, i.e., ulcer cleansing and compression dressings.

The planned total duration of the clinical trial, during which we offer free treatment of lower limb ulcers, is 5 months. During this time, the patient will have 8 free consultations at the WILMED Specialist Clinic, every 4 weeks. Additionally, a qualified nurse will perform daily compression dressings using the aforementioned medication or comparator substance at the patient’s place of residence.

Treatment within this clinical trial is intended for individuals:

• adults, female and male, over 18 years of age, diagnosed with a lower limb ulcer lasting no less than 2 months and no longer than 4 years;
• with an ulcer size to be treated ranging from 5 to 40 cm2;
• who have undergone Doppler ultrasound examination of venous and arterial vessels with ABPI index measurement performed no earlier than 6 months before inclusion in the study. Patients who have never undergone such assessment or whose examination is older will have free diagnostics performed at the WILMED Clinic.

Persons who CANNOT be included in the treatment within the study include, among others:

• those diagnosed with a different type of ulcer;
• with severe arterial insufficiency;
• with advanced diabetes;
• with severe liver or kidney disease diagnosed within 3 months before inclusion in the study;
• after or during cancer treatment;
• who have used any topical product containing hyaluronic acid within the last 3 months.

The study is conducted by Bioconcept, WILMED Medical Center – ul. Wiktorii Wiedeńskiej 9A lok. U2 in Warsaw.

To learn more, contact the Clinical Trials Department of our center at trials@wilmed.pl or by phone at 692-407-540 (Mon-Fri 8:00-20:00)