Diabeetikoiden ihohaavojen paranemiseen liittyvien henkilökohtaisten ravitsemustoimenpiteiden arviointi
Yksilöllisen ravitsemusintervention arviointi yhdessä MSC-peräisten eksosomien soveltamisen kanssa diabeetikkojen ihohaavojen regeneratiiviseen kapasiteettiin ja haavan paranemiseen
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Andalusia
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Córdoba, Andalusia, Espanja, 14004
- Hospital Universitario Reina Sofía de Córdoba
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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 |
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. |
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Ei väliintuloa: Control (C)
Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Ulcer evaluation
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Composite measure of markers of nutritional status
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Composite measure of haemogram
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Hemoglobin A1c (HbA1c) Test for Diabetes
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Measure of markers of nutritional status, include to thyrotropin
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Ultrasensitive C-reactive Protein (CRP) test
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Quantification of circulating endothelial progenitor cells (EPC)
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA)
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Nutritional Risk
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Diagnosis of malnutrition
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Sarcopenia
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Handgrip Strength
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Body weight and height
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Tricipital skinfold
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Arm circumference
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Waist and hip circumferences
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Body Fat
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Muscle Mass
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Hydration status
Aikaikkuna: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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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
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Antonio Casado-Díaz, PhD, Maimonides Biomedical Research Institute of Cordoba
- Päätutkija: Alfonso Calañas, PhD, Hospital General Universitario Reina Sofía de Murcia
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
- Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
- Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19.
- Basiri R, Spicer MT, Levenson CW, Ormsbee MJ, Ledermann T, Arjmandi BH. Nutritional Supplementation Concurrent with Nutrition Education Accelerates the Wound Healing Process in Patients with Diabetic Foot Ulcers. Biomedicines. 2020 Aug 3;8(8):263. doi: 10.3390/biomedicines8080263.
- Haughey L, Barbul A. Nutrition and Lower Extremity Ulcers: Causality and/or Treatment. Int J Low Extrem Wounds. 2017 Dec;16(4):238-243. doi: 10.1177/1534734617737639. Epub 2017 Nov 16.
- Kurian SJ, Miraj SS, Benson R, Munisamy M, Saravu K, Rodrigues GS, Rao M. Vitamin D Supplementation in Diabetic Foot Ulcers: A Current Perspective. Curr Diabetes Rev. 2021;17(4):512-521. doi: 10.2174/1573399816999201012195735.
- Zhang SS, Tang ZY, Fang P, Qian HJ, Xu L, Ning G. Nutritional status deteriorates as the severity of diabetic foot ulcers increases and independently associates with prognosis. Exp Ther Med. 2013 Jan;5(1):215-222. doi: 10.3892/etm.2012.780. Epub 2012 Oct 30.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Endokriinisen järjestelmän sairaudet
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Ravitsemushäiriöt
- Metaboliset sairaudet
- Glukoosiaineenvaihduntahäiriöt
- Diabeettiset angiopatiat
- Diabeteksen komplikaatiot
- Ihosairaudet
- Ihon haavauma
- Jalkahaava
- Diabeettiset neuropatiat
- Jalkahaava
- Ravitsemukselliset ja aineenvaihduntataudit
- Iho- ja sidekudostaudit
- Aliravitsemus
- Diabetes mellitus
- Diabeettinen jalka
Muut tutkimustunnusnumerot
- PI21/01935
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