Fungal Infection in Patients With Diabetic Foot Osteomyelitis

July 30, 2019 updated by: Rowyda El-sayed Gooda Ali, Assiut University

The Effect of Fungal Infection on the Outcome Among Diabetic Patients With Foot Osteomyelitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Approximately 60% of diabetic foot ulcers (DFUs) are complicated by infection. In more than two-thirds of the cases, infection is the main cause for major lower limb amputation in diabetic patients with foot ulceration. Infections may complicate DFUs in both neuropathic and ischemic ulcers.

However, the simultaneous presence of peripheral arterial disease (PAD) and infection influence the evolution of DFUs, increasing the risk of non-healing and major amputation.

Osteomyelitis is usually due to non-healing ulcers and it is associated with high risk of major amputation.

Osteomyelitis can affect any bone but most frequently the forefoot (90%), followed by the midfoot (5%) and the hindfoot (5%). Forefoot have a better prognosis than midfoot and hindfoot osteomyelitis. Above the ankle amputation risk is significantly higher for hindfoot (50%), than midfoot (18.5%) and forefoot (0.33%).

The diagnosis of osteomyelitis should be first based on clinical signs of infection supported by laboratory, microbiological and radiological evaluation. However, the diagnosis remains a challenge and DFO is often not recognized easily in its initial phase.

Infected wounds usually show purulent secretions or at least two signs of inflammation (swelling, erythema, blood serum secretion or simply blood with or without bone fragments). However, DFO can occur without any local sign of inflammation. Systemic symptoms such as fever and malaise are rare, especially in case of chronic osteomyelitis.

Various clinical findings can help clinicians in detecting bone infection. Two specific clinical signs are predictive of osteomyelitis. The first is the width and depth of the foot ulcer. An ulcer larger than 2 cm2 has a sensitivity of 56% and a specificity of 92%. Deep ulcers (> 3 mm) are more easily associated with an underlying osteomyelitis than superficial ulcers (82% vs 33%).

A second diagnostic criterion to detect DFO is the "probe-to-bone test" (PTB). PBT is performed probing the ulcer area with a sterile blunt probe. If the probe reaches the bone surface the PTB is considered positive. In a study involving 75 diabetic patients, PTB showed a sensitivity of 66%, a specificity of 85% and a positive predictive value of 89%. The same test, evaluated in a subsequent prospective study of 1666 diabetic patients and compared with the culture of infected bones, was found to have a sensitivity of 87%, a specificity of 91%, a positive predictive value of only 57% and a negative predictive value of 98%.

Therefore, in the presence of infected ulcers, a positive PTB test is highly suggestive of osteomyelitis, but a negative test does not exclude it. Instead, in presence of an ulcer without clinical signs of infection, a positive test may be not specific for osteomyelitis while a negative PBT test should exclude a bone infection.

The combination of the PTB test with X-ray improve the sensitivity and specificity in the diagnosis of DFO. Bone infection is also considered in case of visible or exposed bone or discharge of bone fragments.

Diabetic foot osteomyelitis (DFO) is mostly the consequence of a soft tissue infection that spreads into the bone, involving the cortex first and then the marrow. The possible bone involvement should be suspected in all DFUs patients with infection clinical findings, in chronic wounds and in case of ulcer recurrence.The bacterial flora involved has been characterized in much detail and highlights a contemporaneous role for many organisms, both aerobic and anaerobic, in the infective process at a single ulcer site, the metabolic deregulation following DFO may lead to hyperglycemia and a degree of immunocompromise, factors allowing fungi to thrive. In addition, many patients with chronic DFU receive multiple courses of broad-spectrum antibiotics, altering the within wound milieu, suppressing normal flora, and thereby allowing the proliferation of opportunistic pathogens..

Fungal osteomyelitis (OM) is relatively rare. There is scarce literature discussing fungal OM in diabetic foot infections (DFIs).

A role for fungal infection in the pathogenesis of diabetic foot lesions has been suggested previously but remains unstudied

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut,71511, Egypt
        • Assuit University,71511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • All diabetic foot ulcers with osteomyelitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"through study completion, an average of 2 year".

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mostafa Haridy, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fungal diabetic osteomyelitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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