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Cited by 61

The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.

Macrophage stimulating agent soluble yeast β‐1,3/1,6‐glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo‐controlled phase II study

Zykova, Svetlana N, Balandina, Ksenia A, Vorokhobina, Natalia V, Kuznetsova, Alla V, Engstad, Rolf, Zykova, Tatiana A·2014·Journal of Diabetes Investigation
DOI 10.1111/jdi.12165
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Abstract

Aims/Introduction: Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus. β‐Glucans are potent inducers of immune function. The present randomized, double blind, two‐center, placebo‐controlled study was undertaken to explore safety, tolerability and efficacy of soluble β‐1,3/1,6‐glucan (SBG) as a local treatment of diabetic foot ulcers. Materials and Methods: A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers (Wagner grade 1–2, Ankle/Brachial Index ≥0.7) received SBG or a comparator product (methylcellulose) locally three times weekly up to 12 weeks in addition to conventional management scheme. A total of 54 patients completed the study. Results: A tendency for shorter median time to complete healing in the SBG group was observed (36 vs 63 days, P = 0.130). Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1–2, 3–4 and 5–6 (P < 0.05). The proportion of ulcers healed by week 12 was also in favor of SBG (59% vs 37%, P = 0.09), with a significantly higher healing incidence in the SBG group at week 8 (44% vs 17%, P = 0.03). SBG was safe and well tolerated. There was a clinically significant difference regarding the incidence of serious adverse events in favor of the SBG treatment. Conclusions: Local treatment of diabetic lower extremity ulcers with β‐1,3/1,6‐polyglucose shows good safety results. This β‐glucan preparation shows promising potential as a treatment accelerating cutaneous healing. Further studies are required to confirm this effect. This trial was registered with ClinicalTrials.gov (no. NCT00288392).

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Metadata

Authors
Zykova, S. N., Balandina, K. A., Vorokhobina, N. V., Kuznetsova, A. V., Engstad, R., & Zykova, T. A.
Venue
Journal of Diabetes Investigation
Publisher
Wiley
Published
2013-12-02
Volume
5
Issue
4
Pages
392-399
ISSN
  • 2040-1116
  • 2040-1124
DOI
10.1111/jdi.12165
Cited by
61
References
31
Language
en
Licence
creativecommons.org/licenses/by-nc/3.0/ (vor)
Funders
  • Biotec Pharmacon ASA
  • The Research Council of Norway

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