Foot, Diabetic
Conditions
Keywords
Dietary Supplementations, Wound Healing, Diabetes Mellitus, Malnutrition
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPersonalized 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.
Sponsors
Instituto de Salud Carlos III
Hospital Universitario Reina Sofia de Cordoba
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite measure of haemogram | 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 |
| Hemoglobin A1c (HbA1c) Test for Diabetes | 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 |
| Measure of markers of nutritional status, include to thyrotropin | 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 |
| Composite measure of markers of nutritional status | 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 |
| Quantification of circulating endothelial progenitor cells (EPC) | 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 |
| Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA) | 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 |
| Ultrasensitive C-reactive Protein (CRP) test | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Fat | 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 |
| Nutritional Risk | 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) |
| Hydration status | 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 |
| Muscle Mass | 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 |
| Diagnosis of malnutrition | 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) |
| Sarcopenia | 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 |
| Handgrip Strength | 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 |
| Body weight and height | 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 |
| Tricipital skinfold | 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 |
| Arm circumference | 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) |
| Waist and hip circumferences | 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 |
Countries
Spain
Contacts
Primary ContactAntonio Casado-Díaz, PhD
Backup ContactMarta Camacho-Cardenosa, PhD
Outcome results
None listed