Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Launched by ANDALUSIAN NETWORK FOR DESIGN AND TRANSLATION OF ADVANCED THERAPIES · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for venous ulcers, which are painful sores on the lower legs caused by poor blood flow. The researchers want to see if using special stem cells from fat tissue, combined with a biological material, can help heal these ulcers. This trial is currently looking for participants aged 18 and older who have an active or recurring venous ulcer that is between 5-10 cm² in size. To be eligible, participants must also be able to travel independently to the treatment center and have certain blood flow measurements in their legs.

If you join this trial, you will receive treatment and regular check-ups to monitor your progress. While the study focuses on safety and effectiveness, it is important to note that certain people may not be eligible, including those with specific health conditions like obesity, active infections, or other serious medical issues. This trial is an early step in testing a potentially new way to help heal venous ulcers, and it offers a chance to contribute to important medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signing of the informed consent (IC) after reading the patient information sheet.
• • 2. Over 18 years of both sexes.
• • 3. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
• • 4. Grade III injury on the Widmer scale.
• • 5. Independence and/or availability to go to the referral center on an outpatient basis.
• • 6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3
• Exclusion Criteria:
• • 1. Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
• • 2. Grade III obesity with a body mass index (BMI) \>40; or underweight patients (BMI \<18.5).
• • 3. Active neoplasia and/or being treated with cytostatics.
• • 4. Patients undergoing radiotherapy treatment in areas close to the lesion.
• • 5. Clinical signs of colonization or local infection of the lesion.
• • 6. Patients with more than one lesion compatible with UV in the same lower limb.
• • 7. Erysipelas.
• • 8. Infectious cellulite.
• • 9. Osteomyelitis.
• • 10. Lymphangitis.
• • 11. Chronic lymphedema.
• • 12. Therapy with corticosteroids or immunosuppressants.
• • 13. Venous ulcer grade I or II on the Widmer scale.
• • 14. Lesions close to possible or diagnosed cancerous lesions.
• • 15. Non-localized wounds in the lower extremities.
• • 16. Ongoing infection and/or sepsis.
• • 17. Critical ischemia in the lower limbs or other venous diseases of unknown origin.
• • 18. Immunocompromised patients.
• • 19. Dependent patients with severe mobility limitations.
• • 20. Dialysis patients.