An interventional study of Personalized Nutritional Intervention in Foot, Diabetic, sponsored by Maimónides Biomedical Research Institute of Córdoba. Recruiting at 1 site in Spain. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Not applicable, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Dietary Supplement: Personalized Nutritional Intervention
Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice
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.
Ulcer evaluation
Change from baseline in size ulcer assessed by picture, including ruler to measure their size
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Composite measure of markers of nutritional status
Change from baseline in nutritional status assessed from blood samples
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Composite measure of haemogram
Change from baseline in haemogram assessed from blood samples
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Hemoglobin A1c (HbA1c) Test for Diabetes
Change from baseline in HbA1c (%) assessed from blood samples
Time frame: 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
Change from baseline in thyrotropin (mlU/L) assessed from blood samples
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Ultrasensitive C-reactive Protein (CRP) test
Change from baseline in CRP (mg/L) assessed from blood samples
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Quantification of circulating endothelial progenitor cells (EPC)
Change from baseline in total CD34+ or CD133+ cells expressing vascular endothelial growth factor receptor 2 (VEGFR2) analyzed by flow cytometry
Time frame: 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)
Change from baseline in concentration of SDF-1 and VEGFA factors in serum by ELISA
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Nutritional Risk
Change from baseline in nutritional risk assessed by Malnutrition Universal Screening Tool (MUST)
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Diagnosis of malnutrition
Change from baseline in diagnosis of malnutrition assessed by Global Leadership Initiative on malnutrition (GLIM criteria)
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Sarcopenia
Change from baseline in sarcopenia assessed by SARC-F
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Handgrip Strength
Change from baseline in handgrip strength assessed by dynamometry
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Body weight and height
Body weight and height will be combined to report body mass index (BMI) in kg/m\^2. Change from baseline in BMI
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Tricipital skinfold
Change from baseline in tricipital skinfold using a skinfold caliper
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Arm circumference
Change from baseline in arm circumference in centimeters (cm)
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Waist and hip circumferences
waist and hip circumferences (cm) will be combined to report Waist and Hip Ratio (WHR). Change from baseline in WHR
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Body Fat
Change from baseline in body fat assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Muscle Mass
Change from baseline in muscle mass assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Hydration status
Change from baseline in hydration status assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis
Time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
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Maimónides Biomedical Research Institute of Córdoba