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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Intervention (NI) | Experimental | 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 |
|
| Control (C) | No Intervention | Who will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Nutritional Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer evaluation | Change from baseline in size ulcer assessed by picture, including ruler to measure their size | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of markers of nutritional status | Change from baseline in nutritional status assessed from blood samples | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Composite measure of haemogram |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Risk | Change from baseline in nutritional risk assessed by Malnutrition Universal Screening Tool (MUST) | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Diagnosis of malnutrition |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Casado-Díaz, PhD | Contact | 957213814 | bb1cadia@uco.es | |
| Marta Camacho-Cardenosa, PhD | Contact | marta.camacho@imibic.org |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Casado-Díaz, PhD | Maimonides Biomedical Research Institute of Cordoba | Principal Investigator |
| Alfonso Calañas, PhD | Hospital General Universitario Reina Sofía de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía de Córdoba | Recruiting | Córdoba | Andalusia | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24867069 | Background | Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19. | |
| 32756299 |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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|
Change from baseline in haemogram assessed from blood samples |
| Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Hemoglobin A1c (HbA1c) Test for Diabetes | Change from baseline in HbA1c (%) assessed from blood samples | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Measure of markers of nutritional status, include to thyrotropin | Change from baseline in thyrotropin (mlU/L) assessed from blood samples | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Ultrasensitive C-reactive Protein (CRP) test | Change from baseline in CRP (mg/L) assessed from blood samples | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Quantification of circulating endothelial progenitor cells (EPC) | Change from baseline in total CD34+ or CD133+ cells expressing vascular endothelial growth factor receptor 2 (VEGFR2) analyzed by flow cytometry | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA) | Change from baseline in concentration of SDF-1 and VEGFA factors in serum by ELISA | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
Change from baseline in diagnosis of malnutrition assessed by Global Leadership Initiative on malnutrition (GLIM criteria) |
| Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Sarcopenia | Change from baseline in sarcopenia assessed by SARC-F | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Handgrip Strength | Change from baseline in handgrip strength assessed by dynamometry | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Body weight and height | Body weight and height will be combined to report body mass index (BMI) in kg/m^2. Change from baseline in BMI | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Tricipital skinfold | Change from baseline in tricipital skinfold using a skinfold caliper | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Arm circumference | Change from baseline in arm circumference in centimeters (cm) | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Waist and hip circumferences | waist and hip circumferences (cm) will be combined to report Waist and Hip Ratio (WHR). Change from baseline in WHR | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Body Fat | Change from baseline in body fat assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Muscle Mass | Change from baseline in muscle mass assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Hydration status | Change from baseline in hydration status assessed by multifrequency bioimpedaciometry and bioelectrical impedance vector analysis | Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation |
| Background |
| Basiri R, Spicer MT, Levenson CW, Ormsbee MJ, Ledermann T, Arjmandi BH. Nutritional Supplementation Concurrent with Nutrition Education Accelerates the Wound Healing Process in Patients with Diabetic Foot Ulcers. Biomedicines. 2020 Aug 3;8(8):263. doi: 10.3390/biomedicines8080263. |
| 30181091 | Background | Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3. |
| 29145757 | Background | Haughey L, Barbul A. Nutrition and Lower Extremity Ulcers: Causality and/or Treatment. Int J Low Extrem Wounds. 2017 Dec;16(4):238-243. doi: 10.1177/1534734617737639. Epub 2017 Nov 16. |
| 33045979 | Background | Kurian SJ, Miraj SS, Benson R, Munisamy M, Saravu K, Rodrigues GS, Rao M. Vitamin D Supplementation in Diabetic Foot Ulcers: A Current Perspective. Curr Diabetes Rev. 2021;17(4):512-521. doi: 10.2174/1573399816999201012195735. |
| 23810110 | Background | 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. |
| 23251271 | Background | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009748 | Nutrition Disorders |