Sage Journals: Discover world-class research

Abstract

The aim of this study was to evaluate the efficacy and safety of a mixed probiotics formulation (MPF) combined with standard care for treating diabetic foot (DF), specifically targeting infection control, ulcer healing, and wound recovery. Seventy DF patients were randomly assigned to receive standard therapy alone or in combination with MPF. Following the treatment, ankle-brachial index (ABI), wound characteristics, inflammatory markers, ultrasound measurements, vascular endothelial markers, blood glucose levels, and recurrence rates were evaluated at 8-week and 12-week timepoints. Significant improvements were observed in the MPF-treated group after 12 weeks compared to the control group, including reductions in body mass index (BMI) and waist circumference (p < 0.05), as well as improvements in wound healing outcomes, ABI scores (p < 0.05), ultrasound parameters, and vascular endothelial markers (p < 0.05). While blood glucose levels decreased similarly in both groups (p > 0.05), the MPF group exhibited a lower recurrence rate (11.43%) compared to the control group (25.71%). Importantly, MPF was well-tolerated with no adverse events reported. In conclusion, MPF, when used alongside standard care, significantly improves BMI, waist circumference, ABI scores, wound healing, and vascular parameters in DF patients. These findings indicated the potential of MPF for clinical application in the management and prevention of diabetic foot complications.

Keywords

diabetic foot foot ulcer probiotics clinical observation wound healing

Get full access to this article

View all access options for this article.

References

Wang

Cheng

, et al. Guidelines on multidisciplinary approaches for the prevention and management of diabetic foot disease (2020 edition). Burns Trauma. 2020;8(eCollection 2020):tkaa017.

Hinchliffe

Andros

Apelqvist

, et al. A systematic review of the effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease. Diabetes Metab Res Rev. 2012;28(Suppl 1):179–217.

Pecoraro

Reiber

Burgess

. Pathways to diabetic limb amputation: Basis for prevention. Diabetes Care. 1990;13(5):513–521.

Gardner

Hillis

Frantz

. Clinical signs of infection in diabetic foot ulcers with high microbial load. Biol Res Nurs. 2009;11(2):119–128.

Ozan

Gürbüz

Çelik

, et al. Evaluation of major and minor lower extremity amputation in diabetic foot patients. Turk J Med Sci. 2017;47(4):1109–1116.

Vadiveloo

Jeffcoate

Donnan

, et al. Amputation-free survival in 17,353 people at high risk for foot ulceration in diabetes: A national observational study. Diabetologia. 2018;61(12):2590–2597.

Wang

S-H

Sun

Z-L

Guo

Y-J

, et al. Meticillin-resistant Staphylococcus aureus isolated from foot ulcers in diabetic patients in a Chinese care hospital: Risk factors for infection and prevalence. J Med Microbiol. 2010;59(10):1219–1224.

Association

. 11. Microvascular complications and foot care: Standards of medical care in diabetes—2019. Diabetes Care. 2019;42(Supplement_1):S124–S138.

Ibrahim

. IDF Clinical Practice Recommendation on the Diabetic Foot: A Guide for Healthcare Professionals. Elsevier; 2017, 285–287.

10.

Jenab

Morteza

Nozari

, et al. Diabetic foot ulcer is a significant predictor of silent myocardial ischemia in women with type 2 diabetes. J Diabetes Metab. 2011;2(161):2.

11.

Niță

Arhire

Mihalache

, et al. Evaluating Classification Systems of Diabetic Foot Ulcer Severity: A 12-Year Retrospective Study on Factors Impacting Survival. Healthcare. 2023;11(14):2077.

12.

Everett

Mathioudakis

. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018;1411(1):153–165.

13.

Hirsch

Koerber

Jacobsen

, et al. Evaluation of toxic side effects of clinically used skin antiseptics in vitro. J Surg Res. 2010;164(2):344–350.

14.

Kingsley

Lewis

. Debridement and wound biofilms. J Wound Care. 2011;20(6):284–284.

15.

Mori

Nakagami

Kitamura

, et al. Effectiveness of biofilm-based wound care system on wound healing in chronic wounds. Wound Repair Regen. 2019;27(5):540–547.

16.

Cani

Osto

Geurts

, et al. Involvement of gut microbiota in the development of low-grade inflammation and type 2 diabetes associated with obesity. Gut Microbes. 2012;3(4):279–288.

17.

Kobyliak

Conte

Cammarota

, et al. Probiotics in prevention and treatment of obesity: A critical view. Nutr Metab (Lond). 2016;13(eCollection 2016):1–13.

18.

Hill

Guarner

Reid

, et al. The international scientific association for probiotics and prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nature Reviews Gastroenterology & Hepatology. 2014;11(8):506–514.

19.

Akbari

Hendijani

. Effects of probiotic supplementation in patients with type 2 diabetes: Systematic review and meta-analysis. Nutr Rev. 2016;74(12):774–784.

20.

Al-Salami

Butt

Fawcett

J P

et al. Probiotic treatment reduces blood glucose levels and increases systemic absorption of gliclazide in diabetic rats. Eur J Drug Metab Pharmacokinet. 2008;33(2):101–106.

21.

Mohamadshahi

Veissi

Haidari

, et al. Effects of probiotic yogurt consumption on inflammatory biomarkers in patients with type 2 diabetes. BioImpacts: BI. 2014;4(2):83.

22.

Taira

Yamaguchi

Shimizu

, et al. Bacterial cell wall components regulate adipokine secretion from visceral adipocytes. J Clin Biochem Nutr. 2015;56(2):149–154.

23.

Sepideh

Karim

Hossein

, et al. Effects of multistrain probiotic supplementation on glycemic and inflammatory indices in patients with nonalcoholic fatty liver disease: A double-blind randomized clinical trial. J Am Coll Nutr. 2016;35(6):500–505.

24.

Das

Chen

C-M

S-C

, et al. Medicinal components in edible mushrooms on diabetes mellitus treatment. Pharmaceutics. 2022;14(2):436.

25.

Kolundzic

Grozdanić

NĐ

Stanojković

, et al. Antimicrobial and cytotoxic activities of the sulphur shelf medicinal mushroom, Laetiporus sulphureus (Agaricomycetes), from Serbia. Int J Med Mushrooms. 2016;18(6):469–476.

26.

Saba

Son

Jeon

, et al. Acetyl eburicoic acid from laetiporus sulphureus var. miniatus suppresses inflammation in murine macrophage RAW 264.7 cells. Mycobiology. 2015;43(2):131–136.

27.

Sułkowska-Ziaja

Grabowska

Apola

, et al. Mycelial culture extracts of selected wood-decay mushrooms as a source of skin-protecting factors. Biotechnol Lett. 2021;43(5):1051–1061.

28.

Zschätzsch

Steudler

Reinhardt

, et al. Production of natural colorants by liquid fermentation with Chlorociboria aeruginascens and Laetiporus sulphureus and prospective applications. Eng Life Sci. 2021;21(3-4):270–282.

29.

Bowers

Franco

. Chronic wounds: Evaluation and management. Am Fam Physician. 2020;101(3):159–166.

30.

Cristofori

Dargenio

, et al. Anti-inflammatory and immunomodulatory effects of probiotics in gut inflammation: A door to the body. Front Immunol. 2021;12(eCollection 2021):578386.

31.

Singh

Sharma

Malhotra

, et al. Lactobacillus rhamnosus NCDC17 ameliorates type-2 diabetes by improving gut function, oxidative stress and inflammation in high-fat-diet fed and streptozotocintreated rats. Benefic Microbes. 2017;8(2):243–255.

32.

Rijkers

Bengmark

Enck,

, et al. Guidance for substantiating the evidence for beneficial effects of probiotics: Current status and recommendations for future research. J Nutr. 2010;140(3):671S–676S.

33.

Song

Xue

Zhang

, et al. Amelioration of type 2 diabetes using four strains of Lactobacillus probiotics: Effects on gut microbiota reconstitution-mediated regulation of glucose homeostasis, inflammation, and oxidative stress in mice. J Agric Food Chem. 2023;71(51):20801–20814.

34.

Kurkipuro

Mierau

Wirth

, et al. Four in one—combination therapy using live Lactococcus lactis expressing three therapeutic proteins for the treatment of chronic non-healing wounds. PLoS One. 2022;17(2):e0264775.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.03 MB