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Clinical Trial with Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs.
EU CTIS ID: 2024-513151-33-00
What this study is testing
Feasibility and Safety
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (C6 according to the CEAC clinical classification, Annex 5)” in the lower extremity with an area between 5-10 cm2. 4. Grade III injury on the Widmer scale. 5. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3.
You likely can't join if
- 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. The following comorbidities will be allowed: peripheral vascular disease, coronary heart disease, chronic kidney disease, chronic liver disease, and arterial hypertension. 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. Lymphangitis in the limb to be treated. 7. Chronic lymphedema in the limb to be treated. 8. Venous ulcer grade I or II on the Widmer scale. 9. Lesions close to possible or diagnosed cancerous lesions. 10. Non-localized wounds in the lower extremities. 11. Ongoing systemic infection. 12. Critical ischemia in the lower limbs or other venous diseases of unknown origin. 13. Immunocompromised patients. 14. Dialysis patients. 15. Thalassemia patients. 16. Decompensated heart failure. 17. Pregnant and lactating women. 18. Any other recurrent illness or condition that, in the opinion of the investigator, would make the patient ineligible to participate in the trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.