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

NCT ID: NCT05243368

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-12-31

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.

Conditions

Foot, Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Personalized Nutritional Intervention

Intervention Type: DIETARY_SUPPLEMENT

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.

Control (C)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personalized 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Casado-Díaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Biomedical Research Institute of Cordoba

Alfonso Calañas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Andalusia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Antonio Casado-Díaz, PhD

Role: CONTACT

bb1cadia@uco.es

957213814

Marta Camacho-Cardenosa, PhD

Role: CONTACT

marta.camacho@imibic.org

Facility Contacts

Alfonso Calañas, PhD

Role: primary

alfonso.calanas.sspa@juntadeandalucia.es

957010000

References

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Reference Type: BACKGROUND

PMID: 24867069 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 29145757 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33045979 (View on PubMed)

Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.

Reference Type: BACKGROUND

PMID: 23810110 (View on PubMed)

Zhang SS, Tang ZY, Fang P, Qian HJ, Xu L, Ning G. Nutritional status deteriorates as the severity of diabetic foot ulcers increases and independently associates with prognosis. Exp Ther Med. 2013 Jan;5(1):215-222. doi: 10.3892/etm.2012.780. Epub 2012 Oct 30.

Reference Type: BACKGROUND

PMID: 23251271 (View on PubMed)

Other Identifiers

PI21/01935

Identifier Type: -

Identifier Source: org_study_id