CTIS2024-513151-33-00进行中（未招募）1 期
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 expanded on fibrin-hyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
Fundacion Progreso Y Salud0 个研究点目标入组 20 人开始时间: 2024年4月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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