Clinical Trial with Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs.
- Conditions
- Venous ulcer of the lower limbsMedDRA version: 21.1Level: LLTClassification code: 10047259Term: Venous ulcer NOS Class: 10040785Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-513151-33-00
- Lead Sponsor
- Fundacion Progreso Y Salud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.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.
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.Patients with more than one lesion compatible with UV in the same lower limb. 7.Any cutaneous infection. 8.Lymphangitis in the limb to be treated. 9.Chronic lymphedema in the limb to be treated. 10.Venous ulcer grade I or II on the Widmer scale. 11.Lesions close to possible or diagnosed cancerous lesions. 12.Non-localized wounds in the lower extremities. 13.Ongoing systemic infection. 14.Critical ischemia in the lower limbs or other venous diseases of unknown origin. 15.Immunocompromised patients. 16.Dependent patients with severe mobility limitations. 17.Dialysis patients. 18.Thalassemia patients. 19.Decompensated heart failure. 20.Pregnant and lactating women. 21.Any other recurrent illness or condition that, in the opinion of the investigator, would make the patient ineligible to participate in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Feasibility and Safety;Secondary Objective: 1.To determine the effect of the experimental treatment on wound closure time compared to the control group. 2.To assess the effect of the experimental treatment on the healing evolution of the lesion, in terms of depth, size, type of edges, tissue and exudate compared to the control group. 3.To assess the effect of the experimental treatment on the concentration of growth factors closely related to wound healing (cytokines IL-6, IL-4, TGF-ß1 and IL-10) in the exudate of the lesion in on day 0, +7, +14, +21 and +28 compared to the control group and its possible relationship with the rest of the efficacy parameters. 4.Evaluate the evolution of pain derived from the presence of UVs in the group treated with the PEI, in comparison with the control group. 5.To determine the perceived quality of life after treatment with the experimental treatment compared to the control group.;Primary end point(s): Feasibility and Safety
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1.To determine the effect of the IMP on wound closure time compared to control group.2.To assess the effect of the IMP on the healing evolution of the lesion vs control group.3.To assess the effect of IMP on the concentration of GF closely related to wound healing.4.Evaluate the evolution of pain derived from the presence of UVs in the group treated with the IMP vs control group.5.To determine the perceived quality of life after treatment with the IMP vs control group.