Status:
UNKNOWN
Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
Lead Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expa...
Eligibility Criteria
Inclusion
- Signing of the informed consent (IC) after reading the patient information sheet.
- Over 18 years of both sexes.
- Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
- Grade III injury on the Widmer scale.
- Independence and/or availability to go to the referral center on an outpatient basis.
- Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3
Exclusion
- 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.
- Grade III obesity with a body mass index (BMI) \>40; or underweight patients (BMI \<18.5).
- Active neoplasia and/or being treated with cytostatics.
- Patients undergoing radiotherapy treatment in areas close to the lesion.
- Clinical signs of colonization or local infection of the lesion.
- Patients with more than one lesion compatible with UV in the same lower limb.
- Erysipelas.
- Infectious cellulite.
- Osteomyelitis.
- Lymphangitis.
- Chronic lymphedema.
- Therapy with corticosteroids or immunosuppressants.
- Venous ulcer grade I or II on the Widmer scale.
- Lesions close to possible or diagnosed cancerous lesions.
- Non-localized wounds in the lower extremities.
- Ongoing infection and/or sepsis.
- Critical ischemia in the lower limbs or other venous diseases of unknown origin.
- Immunocompromised patients.
- Dependent patients with severe mobility limitations.
- Dialysis patients.
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05962931
Start Date
July 12 2023
End Date
July 1 2025
Last Update
July 27 2023
Active Locations (3)
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1
Unidad de A.P. de Alfacar
Alfacar, Granada, Spain, 18170
2
Unidad de A.P. de Atarfe
Atarfe, Granada, Spain, 18290
3
Universidad de Granada
Granada, Spain, 18071