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Studying on the Difference Between Two Kinds of Osteomyelitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240964
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ying Cao, Nanfang Hospital of Southern Medical University

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

Condition or disease
Diabetic Foot Osteomyelitis Diabetic Foot Infection Microbiome

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Studying on the Difference Between Foot Osteomyelitis Patients With or Without Diabetes
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Dd group
Patients with diabetic foot osteomyelitis
ND group
Foot osteomyelitis without diabetes



Primary Outcome Measures :
  1. Composition and Diversity of DFO with 16S rRNA Gene Data [ Time Frame: 2017-2018 ]
    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.

  2. Composition of the DFO Metagenome [ Time Frame: 2018-2019 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with osteomyelitis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240964


Locations
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China, Guangdong
Department of Endocrinology and Metabolism, NanFang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: ying cao, doctor Nanfang Hospital of Southern Medical University
Publications:

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Responsible Party: Ying Cao, associate professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04240964    
Other Study ID Numbers: NFEC-2017-013
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying Cao, Nanfang Hospital of Southern Medical University:
Diabetic Foot Osteomyelitis
16S rRNA
Metagenomes
Microbiome
Additional relevant MeSH terms:
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Osteomyelitis
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases