Studying on the Difference Between Two Kinds of Osteomyelitis

NCT04240964 | Completed

• 1 other identifier: NFEC-2017-013
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the microbial differences of diabetic foot osteomyelitis and osteomyelitis without diabetes.

Conditions

Diabetic Foot Osteomyelitis; Diabetic Foot Infection; Microbiome

Keywords

Diabetic Foot Osteomyelitis; 16S rRNA; Metagenomes; Microbiome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dd group

Patients with diabetic foot osteomyelitis

ND group

Foot osteomyelitis without diabetes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with osteomyelitis

You may qualify if:

• age≥18 years old.
• diagnosed as foot osteomyelitis, and wounds were located below the knee joint.
• nfected bone exposure or positive probe-to-bone test.
• The patients were good physical condition.
• Patients were able to tolerate debridement or operation treatment.
• patients and their families agreed to participate in the study.

You may not qualify if:

• Serious skin diseases around the wound surface;
• tumors affecting the wound of osteomyelitis;
• long-term use of immunosuppressive therapy before admission;
• patients that do not cooperate.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Department of Endocrinology and Metabolism, NanFang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (7)

• 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.

  PMID: 19117631 BACKGROUND

• 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.

  PMID: 18442163 BACKGROUND

• 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.

  PMID: 19929991 BACKGROUND

• 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.

  PMID: 27123004 BACKGROUND

• 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.

  PMID: 24112138 BACKGROUND

• 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.

  PMID: 23300163 BACKGROUND

• 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.

  PMID: 32801139 DERIVED

Study Officials

• ying cao, doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: January 27, 2020
• Study Start: July 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

CN (1)