Sponsor study identifier
observational
28
1 country
1
Study Start
July 1, 2017
Actual (reported)Primary Completion
December 1, 2018
Actual (reported)Study Completion
December 1, 2018
Actual (reported)To explore the microbial differences of diabetic foot osteomyelitis and osteomyelitis without diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2017
Actual (reported)December 1, 2018
Actual (reported)December 1, 2018
Actual (reported)October 28, 2019
Actual (reported)January 27, 2020
Actual (reported)Composition and Diversity of DFO with 16S rRNA Gene Data
Subjects who met the inclusion criteria for diabetic foot osteomyelitis (DFO) (sample size ≥ 10) and osteomyelitis without NDFO (sample size ≥ 10) were collected for debridement and amputation for 16s rDNA high-throughput sequencing. Compare microbe composition and diversity between the two groups.
2017-2018
Composition of the DFO Metagenome
Subjects who met the inclusion criteria for diabetic foot osteomyelitis (DFO) (sample size ≥ 10) and osteomyelitis without NDFO (sample size ≥ 10) were collected for debridement and amputation for Metagenomic Analysis. Compare microbe composition and diversity between the two groups.
2018-2019
Patients with diabetic foot osteomyelitis
Foot osteomyelitis without diabetes
patients with osteomyelitis
Department of Endocrinology and Metabolism, NanFang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Lavery LA, Peters EJ, Armstrong DG, Wendel CS, Murdoch DP, Lipsky BA. Risk factors for developing osteomyelitis in patients with diabetic foot wounds. Diabetes Res Clin Pract. 2009 Mar;83(3):347-52. doi: 10.1016/j.diabres.2008.11.030. Epub 2008 Dec 30.
Berendt AR, Peters EJ, Bakker K, Embil JM, Eneroth M, Hinchliffe RJ, Jeffcoate WJ, Lipsky BA, Senneville E, Teh J, Valk GD. Diabetic foot osteomyelitis: a progress report on diagnosis and a systematic review of treatment. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S145-61. doi: 10.1002/dmrr.836.
ying cao, doctor
Nanfang Hospital, Southern Medical University
28 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2019
First Posted
January 27, 2020
Study Start
July 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Valabhji J, Oliver N, Samarasinghe D, Mali T, Gibbs RG, Gedroyc WM. Conservative management of diabetic forefoot ulceration complicated by underlying osteomyelitis: the benefits of magnetic resonance imaging. Diabet Med. 2009 Nov;26(11):1127-34. doi: 10.1111/j.1464-5491.2009.02828.x.
Huang Y, Cao Y, Zou M, Luo X, Jiang Y, Xue Y, Gao F. A Comparison of Tissue versus Swab Culturing of Infected Diabetic Foot Wounds. Int J Endocrinol. 2016;2016:8198714. doi: 10.1155/2016/8198714. Epub 2016 Mar 30.
Goda A, Maruyama F, Michi Y, Nakagawa I, Harada K. Analysis of the factors affecting the formation of the microbiome associated with chronic osteomyelitis of the jaw. Clin Microbiol Infect. 2014 May;20(5):O309-17. doi: 10.1111/1469-0691.12400. Epub 2013 Nov 11.
Redel H, Gao Z, Li H, Alekseyenko AV, Zhou Y, Perez-Perez GI, Weinstock G, Sodergren E, Blaser MJ. Quantitation and composition of cutaneous microbiota in diabetic and nondiabetic men. J Infect Dis. 2013 Apr;207(7):1105-14. doi: 10.1093/infdis/jit005. Epub 2013 Jan 8.
Zou M, Cai Y, Hu P, Cao Y, Luo X, Fan X, Zhang B, Wu X, Jiang N, Lin Q, Zhou H, Xue Y, Gao F. Analysis of the Composition and Functions of the Microbiome in Diabetic Foot Osteomyelitis Based on 16S rRNA and Metagenome Sequencing Technology. Diabetes. 2020 Nov;69(11):2423-2439. doi: 10.2337/db20-0503. Epub 2020 Aug 14.
Primary Completion
December 1, 2018
Actual (reported)Study Completion
December 1, 2018
Actual (reported)Last Updated
January 27, 2020
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: