Evaluation of Personalized Nutritional Intervention Together With the Application of MSC-derived Exosomes on the Regenerative Capacity and Wound Healing of Cutaneous Ulcers in Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ulcer evaluation
研究概览
简要总结
The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and oxidative stress increases. This is an unfavorable microenvironment for healing. A major risk factor in the development of CCU is nutritional deficiency. Healing needs energy and nutrients for regeneration. In diabetics the malnutrition can be more than 60%. However, although the provision of certain nutrients can improve the healing capacity, it is not a common clinical practice to nutritionally evaluate diabetic with CCU. Exosomes are extracellular vesicles that reflect the physiological state of the cells producing them. Stem cell derivatives exosomes are rich in factors, that can provide a favorable microenvironment for tissue regeneration.
The aim of this project is to develop a therapeutic process to accelerate the healing of diabetic CCU, based on the correction of nutritional deficiencies, to improve the regenerative capacity, together with the application of exosomes from mesenchymal stem-cell (MSC) in the wound, creating a microenvironment that favors tissue regeneration. For this, a pilot clinical trial with diabetic patients with CCU is proposed, to evaluate the effect of personalized nutritional supplementation on healing and regenerative capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of the informed consent
- •Age between 50 and 80 years
- •Diagnosis of Diabetes Mellitus for more than 1 year
- •Documented diagnosis of peripheral artery disease
- •HbA1c < 9%
- •Category 5 in the Rutherford-Becker classification
排除标准
- •Poor cognitive function, dementia or psychiatric conditions
- •Osteomyelitis, gangrene, malignancy or immunocompromised disease
- •Thromboangiitis obliterans or Buerger's disease
- •Clinical evidence of invasive infection in the target limb requiring IV antibiotherapy
- •Presence of neuropathic ulcers only
- •Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive.
结局指标
主要结局
Ulcer evaluation
时间窗: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Change from baseline in size ulcer assessed by picture, including ruler to measure their size
次要结局
- Composite measure of markers of nutritional status(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Composite measure of haemogram(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA)(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Hemoglobin A1c (HbA1c) Test for Diabetes(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Measure of markers of nutritional status, include to thyrotropin(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Ultrasensitive C-reactive Protein (CRP) test(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)
- Quantification of circulating endothelial progenitor cells (EPC)(Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation)