Fungal Infection in Patients With Diabetic Foot Osteomyelitis

NCT04041739 | Unknown

• 1 other identifier: fungal diabetic osteomyelitis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot Osteomyelitis

Keywords

fungal infection

Outcome Measures

Primary Outcomes (1)

• detect magnitude of fungal infection as an etiology causing persistent non healed diabetic foot osteomyelitis

  to evaluate the percentage of fungal infection among foot osteomyelitis and its effect on either healing or amputation.

  "through study completion, an average of 2 year".

Secondary Outcomes (1)

• detect response of healing of resistant infected osteomyelitis to antifungal therapy

  2 years

Study Arms (1)

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of diabetes and ulcer . 2 Clinical examination of ulcer , including diagnosis of osteomyelitis 3- Venous blood will be withdrawn to do the following laboratory tests : * HbA1c * erythrocyte sedimentation rate(ESR) * C reactive protein(CRP) * Complete blood culture * Serum urea and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

Interventions

fungal osteomyelitis culture and sensitivity DIAGNOSTIC_TEST

swabs from ulcer tissue and bone biopsy for culture and sensitivity test and blood sampling

diabetic foot osteomyelitis

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

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 \- Venous blood will be withdrawn to do the following laboratory tests : * HbA1c * erythrocyte sedimentation rate * C reactive protein * Complete blood culture * Serum urea and creatinine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

You may qualify if:

• All diabetic foot ulcers with osteomyelitis

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University,71511

Asyut, Egypt

Location

Related Publications (15)

• Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.

  PMID: 17093942 BACKGROUND

• Reiber GE, Pecoraro RE, Koepsell TD. Risk factors for amputation in patients with diabetes mellitus. A case-control study. Ann Intern Med. 1992 Jul 15;117(2):97-105. doi: 10.7326/0003-4819-117-2-97.

  PMID: 1605439 BACKGROUND

• Nicolau DP, Stein GE. Therapeutic options for diabetic foot infections: a review with an emphasis on tissue penetration characteristics. J Am Podiatr Med Assoc. 2010 Jan-Feb;100(1):52-63. doi: 10.7547/1000052.

  PMID: 20093545 BACKGROUND

• Hill SL, Holtzman GI, Buse R. The effects of peripheral vascular disease with osteomyelitis in the diabetic foot. Am J Surg. 1999 Apr;177(4):282-6. doi: 10.1016/s0002-9610(99)00050-1.

  PMID: 10326843 BACKGROUND

• Mutluoglu M, Sivrioglu AK, Eroglu M, Uzun G, Turhan V, Ay H, Lipsky BA. The implications of the presence of osteomyelitis on outcomes of infected diabetic foot wounds. Scand J Infect Dis. 2013 Jul;45(7):497-503. doi: 10.3109/00365548.2013.765589. Epub 2013 Feb 5.

  PMID: 23384323 BACKGROUND

• Aragon-Sanchez FJ, Cabrera-Galvan JJ, Quintana-Marrero Y, Hernandez-Herrero MJ, Lazaro-Martinez JL, Garcia-Morales E, Beneit-Montesinos JV, Armstrong DG. Outcomes of surgical treatment of diabetic foot osteomyelitis: a series of 185 patients with histopathological confirmation of bone involvement. Diabetologia. 2008 Nov;51(11):1962-70. doi: 10.1007/s00125-008-1131-8. Epub 2008 Aug 22.

  PMID: 18719880 BACKGROUND

• Faglia E, Clerici G, Caminiti M, Curci V, Somalvico F. Influence of osteomyelitis location in the foot of diabetic patients with transtibial amputation. Foot Ankle Int. 2013 Feb;34(2):222-7. doi: 10.1177/1071100712467436. Epub 2013 Jan 10.

  PMID: 23413061 BACKGROUND

• Eneroth M, Larsson J, Apelqvist J. Deep foot infections in patients with diabetes and foot ulcer: an entity with different characteristics, treatments, and prognosis. J Diabetes Complications. 1999 Sep-Dec;13(5-6):254-63. doi: 10.1016/s1056-8727(99)00065-3.

  PMID: 10764999 BACKGROUND

• Lipsky BA. Osteomyelitis of the foot in diabetic patients. Clin Infect Dis. 1997 Dec;25(6):1318-26. doi: 10.1086/516148.

  PMID: 9431370 BACKGROUND

• Grayson ML, Gibbons GW, Balogh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. JAMA. 1995 Mar 1;273(9):721-3.

  PMID: 7853630 BACKGROUND

• Lavery LA, Armstrong DG, Peters EJ, Lipsky BA. Probe-to-bone test for diagnosing diabetic foot osteomyelitis: reliable or relic? Diabetes Care. 2007 Feb;30(2):270-4. doi: 10.2337/dc06-1572.

  PMID: 17259493 BACKGROUND

• Morales Lozano R, Gonzalez Fernandez ML, Martinez Hernandez D, Beneit Montesinos JV, Guisado Jimenez S, Gonzalez Jurado MA. Validating the probe-to-bone test and other tests for diagnosing chronic osteomyelitis in the diabetic foot. Diabetes Care. 2010 Oct;33(10):2140-5. doi: 10.2337/dc09-2309. Epub 2010 Jul 9.

  PMID: 20622159 BACKGROUND

• Aragon-Sanchez J, Lipsky BA, Lazaro-Martinez JL. Diagnosing diabetic foot osteomyelitis: is the combination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet Med. 2011 Feb;28(2):191-4. doi: 10.1111/j.1464-5491.2010.03150.x.

  PMID: 21219428 BACKGROUND

• Alvaro-Afonso FJ, Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E, Garcia-Alvarez Y, Molines-Barroso RJ. Inter-observer reproducibility of diagnosis of diabetic foot osteomyelitis based on a combination of probe-to-bone test and simple radiography. Diabetes Res Clin Pract. 2014 Jul;105(1):e3-5. doi: 10.1016/j.diabres.2014.04.024. Epub 2014 Apr 28.

  PMID: 24857262 BACKGROUND

• Hunt JA. Foot infections in diabetes are rarely due to a single microorganism. Diabet Med. 1992 Oct;9(8):749-52. doi: 10.1111/j.1464-5491.1992.tb01885.x.

  PMID: 1395469 BACKGROUND

MeSH Terms

Conditions

Mycoses

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mostafa Haridy

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Rowyda El-sayed

CONTACT

01000177067; roro.rody.7@gmail.com

Walaa Anwar

CONTACT

01111677728; dr.walaaanwar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 1, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

EG (1)