NCT05243368

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

Status unknown NA Last updated 25 October 2023

What this trial tests

NA trial testing Personalized Nutritional Intervention in Foot, Diabetic in 30 participants. Status unknown.

Timeline

20 October 2023

Primary endpoint
30 June 2024

31 December 2024

Quick facts

Lead sponsor	Maimónides Biomedical Research Institute of Córdoba
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	20 October 2023
Primary completion	30 June 2024
Estimated completion	31 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• Personalized Nutritional Intervention

Conditions studied

• Foot, Diabetic — all drugs for Foot, Diabetic →

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Who can join

Adults 50 to 80, any sex, with Foot, Diabetic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exosomes─Nature's Lipid Nanoparticles, a Rising Star in Drug Delivery and Diagnostics.
   Tenchov R, Sasso JM, Wang X, Liaw WS, et al · · 2022 · cited 336× · PMID 36354238 · DOI 10.1021/acsnano.2c08774
2. Extracellular vesicles: a rising star for therapeutics and drug delivery.
   Du S, Guan Y, Xie A, Yan Z, et al · · 2023 · cited 168× · PMID 37475025 · DOI 10.1186/s12951-023-01973-5
3. Mesenchymal stem cell-derived extracellular vesicles in skin wound healing: roles, opportunities and challenges.
   Ding JY, Chen MJ, Wu LF, Shu GF, et al · · 2023 · cited 117× · PMID 37587531 · DOI 10.1186/s40779-023-00472-w
4. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
5. Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
   Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034
6. Mesenchymal Stem Cell-Derived Extracellular Vesicles for Therapeutic Use and in Bioengineering Applications.
   McLaughlin C, Datta P, Singh YP, Lo A, et al · · 2022 · cited 32× · PMID 36359762 · DOI 10.3390/cells11213366
7. Exosomes for angiogenesis induction in ischemic disorders.
   Moeinabadi-Bidgoli K, Rezaee M, Hossein-Khannazer N, Babajani A, et al · · 2023 · cited 31× · PMID 36786037 · DOI 10.1111/jcmm.17689
8. Exosomes based advancements for application in medical aesthetics.
   Zhang B, Gong J, He L, Khan A, et al · · 2022 · cited 29× · PMID 36605254 · DOI 10.3389/fbioe.2022.1083640