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Evaluering af personlig ernæringsintervention på sårheling af kutane sår hos diabetikere

3. november 2026 opdateret af: Maimónides Biomedical Research Institute of Córdoba

Evaluering af personlig ernæringsintervention sammen med anvendelsen af ​​MSC-afledte exosomer på den regenerative kapacitet og sårheling af kutane sår hos diabetikere

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Kosttilskud: 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.
Ingen indgriben: Control (C)

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ulcer evaluation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite measure of markers of nutritional status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nutritional Risk
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Samarbejdspartnere

Instituto de Salud Carlos III
Hospital Universitario Reina Sofia de Cordoba

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. oktober 2023

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

20. januar 2022

Først indsendt, der opfyldte QC-kriterier

14. februar 2022

Først opslået (Faktiske)

17. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI21/01935

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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