Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
- Conditions
- Foot, Diabetic
- Interventions
- Dietary Supplement: Personalized Nutritional Intervention
- Registration Number
- NCT05243368
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Nutritional Intervention (NI) Personalized Nutritional Intervention 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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
Trial Locations
- Locations (1)
Hospital Universitario Reina Sofía de Córdoba
🇪🇸Córdoba, Andalucía, Spain