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Fungal Infection in Patients With Diabetic Foot Osteomyelitis

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ClinicalTrials.gov Identifier: NCT04041739
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Rowyda El-sayed Gooda Ali, Assiut University

Brief Summary:
estimate the percentage of fungal infection in the pathogenesis of diabetic foot osteomyelitis and assess the outcome of patients with fungal diabetic foot osteomyelitis

Condition or disease Intervention/treatment
Diabetic Foot Osteomyelitis Diagnostic Test: fungal osteomyelitis culture and sensitivity

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Fungal Infection on the Outcome Among Diabetic Patients With Foot Osteomyelitis
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
diabetic foot osteomyelitis

Patients will be subjected to:

1-History taking including duration of diabetes and ulcer . 2 Clinical examination of ulcer , including diagnosis of osteomyelitis 3- Venous blood will be withdrawn to do the following laboratory tests :

  • HbA1c
  • erythrocyte sedimentation rate(ESR)
  • C reactive protein(CRP)
  • Complete blood culture
  • Serum urea and creatinine 4-culture and sensitivity test 5-Bone fragments and tissue biopsy from infected ulcers 6-Fundus examination
Diagnostic Test: fungal osteomyelitis culture and sensitivity
swabs from ulcer tissue and bone biopsy for culture and sensitivity test and blood sampling




Primary Outcome Measures :
  1. detect magnitude of fungal infection as an etiology causing persistent non healed diabetic foot osteomyelitis [ Time Frame: "through study completion, an average of 2 year". ]
    to evaluate the percentage of fungal infection among foot osteomyelitis and its effect on either healing or amputation.


Secondary Outcome Measures :
  1. detect response of healing of resistant infected osteomyelitis to antifungal therapy [ Time Frame: 2 years ]
    to know the impact of adding antifungal treatment may accelerate healing and improve the prognosis.and know the percentage of patients with fungal osteomyelitis healed after antifungal therapy and evaluation of healing response through radiological and laboratory findings



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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

prospective cohort study, The study included 100 patients with diabetic foot osteomyelitis.

They all had long‐standing recurrent foot ulceration in which healing had failed despite intensive foot care .

Ulcer material and bone fragments taken for mycological examination. All ulcers had multiple swabs taken for microbial culture and were examined under direct microscopy .

Tissue specimens were obtained from the depth of the wound (taking aseptic precautions) after debridement.

- Venous blood will be withdrawn to do the following laboratory tests :

  • HbA1c
  • erythrocyte sedimentation rate
  • C reactive protein
  • Complete blood culture
  • Serum urea and creatinine 4-culture and sensitivity test 5-Bone fragments and tissue biopsy from infected ulcers 6-Fundus examination
Criteria

Inclusion Criteria:

  • All diabetic foot ulcers with osteomyelitis

Exclusion Criteria:

  • Patients on corticosteroid therapy.
  • Patients on long term antibiotic therapy.

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): NCT04041739


Contacts
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Contact: Rowyda El-sayed 01000177067 roro.rody.7@gmail.com
Contact: Walaa Anwar 01111677728 dr.walaaanwar@yahoo.com

Locations
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Egypt
Assuit University,71511
Assiut,71511, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mostafa Haridy Assiut University

Publications:

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Responsible Party: Rowyda El-sayed Gooda Ali, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04041739     History of Changes
Other Study ID Numbers: fungal diabetic osteomyelitis
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
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 Rowyda El-sayed Gooda Ali, Assiut University:
fungal infection
Additional relevant MeSH terms:
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Infection
Mycoses
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
Bone Diseases
Musculoskeletal Diseases