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Evaluering av personlig ernæringsintervensjon på sårheling av kutane sår hos diabetikere

3. november 2026 oppdatert av: Maimónides Biomedical Research Institute of Córdoba

Evaluering av personlig ernæringsintervensjon sammen med anvendelse av MSC-avledede eksosomer på regenerativ kapasitet og sårheling av 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Kosttilskudd: 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 inngripen: Control (C)

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Samarbeidspartnere

Instituto de Salud Carlos III
Hospital Universitario Reina Sofia de Cordoba

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. oktober 2023

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

20. januar 2022

Først innsendt som oppfylte QC-kriteriene

14. februar 2022

Først lagt ut (Faktiske)

17. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PI21/01935

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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