Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics

Maimónides Biomedical Research Institute of Córdoba

Status: Enrolling

Conditions: Foot, Diabetic

Treatments: Dietary Supplement: Personalized Nutritional Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05243368

PI21/01935

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

Nutritional Intervention (NI)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Personalized Nutritional Intervention

Control (C)

No Intervention group

Description:

Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice