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Evaluación de la Intervención Nutricional Personalizada en la Cicatrización de Heridas de Úlceras Cutáneas en Diabéticos

3 de noviembre de 2026 actualizado por: Maimónides Biomedical Research Institute of Córdoba

Evaluación de la Intervención Nutricional Personalizada Junto con la Aplicación de Exosomas derivados de MSC sobre la Capacidad Regenerativa y Cicatrizante de Úlceras Cutáneas en Diabéticos

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • España
    • Andalusia
      • Córdoba, Andalusia, España, 14004
        • Hospital Universitario Reina Sofía de Córdoba

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nutritional Intervention (NI)

In addition to the usual treatment, will receive dietary advice and a nutritional supplement, according to the results of their evaluation in the Endocrinology Service
Suplemento dietético: Personalized Nutritional Intervention

Those with malnutrition criteria will also receive a nutritional supplement (e.g. fortimel cubitan, advanced or extra, Nutricia) or another of similar composition, in case of intolerance to the first option. The aim will be to provide at least 50% of the recommended intakes for the main nutrients related to wound healing.
Sin intervención: Control (C)

Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ulcer evaluation
Periodo de tiempo: 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
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Composite measure of markers of nutritional status
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in nutritional status assessed from blood samples
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Composite measure of haemogram
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in haemogram assessed from blood samples
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Hemoglobin A1c (HbA1c) Test for Diabetes
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in HbA1c (%) assessed from blood samples
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
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in thyrotropin (mlU/L) assessed from blood samples
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Ultrasensitive C-reactive Protein (CRP) test
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in CRP (mg/L) assessed from blood samples
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Quantification of circulating endothelial progenitor cells (EPC)
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in total CD34+ or CD133+ cells expressing vascular endothelial growth factor receptor 2 (VEGFR2) analyzed by flow cytometry
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)
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in concentration of SDF-1 and VEGFA factors in serum by ELISA
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Nutritional Risk
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in nutritional risk assessed by Malnutrition Universal Screening Tool (MUST)
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Diagnosis of malnutrition
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in diagnosis of malnutrition assessed by Global Leadership Initiative on malnutrition (GLIM criteria)
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Sarcopenia
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in sarcopenia assessed by SARC-F
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Handgrip Strength
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in handgrip strength assessed by dynamometry
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Body weight and height
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Body weight and height will be combined to report body mass index (BMI) in kg/m^2. Change from baseline in BMI
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Tricipital skinfold
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in tricipital skinfold using a skinfold caliper
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Arm circumference
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in arm circumference in centimeters (cm)
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Waist and hip circumferences
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

waist and hip circumferences (cm) will be combined to report Waist and Hip Ratio (WHR). Change from baseline in WHR
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Body Fat
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in body fat assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Muscle Mass
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in muscle mass assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Hydration status
Periodo de tiempo: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Change from baseline in hydration status assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Maimónides Biomedical Research Institute of Córdoba

Colaboradores

Instituto de Salud Carlos III
Hospital Universitario Reina Sofia de Cordoba

Investigadores

  • Investigador principal: Antonio Casado-Díaz, PhD, Maimonides Biomedical Research Institute of Cordoba
  • Investigador principal: Alfonso Calañas, PhD, Hospital General Universitario Reina Sofía de Murcia

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de octubre de 2023

Finalización primaria (Estimado)

30 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

14 de febrero de 2022

Publicado por primera vez (Actual)

17 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PI21/01935

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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