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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario Reina Sofía de Córdoba
RECRUITING
Córdoba
Contact Information
Primary
Antonio Casado-Díaz, PhD
bb1cadia@uco.es
957213814
Backup
Marta Camacho-Cardenosa, PhD
marta.camacho@imibic.org
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 30
Treatments
Experimental: 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
No_intervention: Control (C)
Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice
Authors
Antonio Casado
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Salud Carlos III, Hospital Universitario Reina Sofia de Cordoba
Leads: Maimónides Biomedical Research Institute of Córdoba

This content was sourced from clinicaltrials.gov