Clinical trial NCT05243368: Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Official title: Evaluation of Personalized Nutritional Intervention Together With the Application of MSC-derived Exosomes on the Regenerative Capacity and Wound Healing of Cutaneous Ulcers in Diabetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot, Diabetic
Keywords: Dietary Supplementations
Wound Healing
Diabetes Mellitus
Malnutrition
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2022-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ulcer evaluation
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Secondary outcomes:
measure: Composite measure of markers of nutritional status
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Composite measure of haemogram
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Hemoglobin A1c (HbA1c) Test for Diabetes
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Measure of markers of nutritional status, include to thyrotropin
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Ultrasensitive C-reactive Protein (CRP) test
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Quantification of circulating endothelial progenitor cells (EPC)
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA)
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Other outcomes:
measure: Nutritional Risk
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Diagnosis of malnutrition
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Sarcopenia
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Handgrip Strength
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Body weight and height
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Tricipital skinfold
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Arm circumference
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Waist and hip circumferences
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Body Fat
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Muscle Mass
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
measure: Hydration status
timeFrame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
state: Andalucía
Study officials:
affiliation: Maimonides Biomedical Research Institute of Cordoba
name: Antonio Casado-Díaz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofía
name: Alfonso Calañas, PhD
role: PRINCIPAL_INVESTIGATOR
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