Diabetic Foot OsteomyelitisNCT04041739
Fungal Infection in Patients With Diabetic Foot Osteomyelitis
An observational study of Diabetic Foot Osteomyelitis, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Osteomyelitis
- What is being tested?
- fungal osteomyelitis culture and sensitivity
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 - Venous blood will be withdrawn to do the following laboratory tests : * HbA1c * erythrocyte sedimentation rate * C reactive protein * Complete blood culture * Serum urea and creatinine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
Who may be able to join
- All diabetic foot ulcers with osteomyelitis
Who cannot join
- Patients on corticosteroid therapy.
- Patients on long term antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Diabetic Foot Osteomyelitis
- Being tested
- fungal osteomyelitis culture and sensitivity
- Keywords
- fungal infection
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fungal osteomyelitis culture and sensitivityDiagnostic test
swabs from ulcer tissue and bone biopsy for culture and sensitivity test and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: fungal osteomyelitis culture and sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "through study completion, an average of 2 year".
Secondary outcomes (1)
detect response of healing of resistant infected osteomyelitis to antifungal therapy
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowyda El-sayed Gooda Ali, Assiut University
- Investigators
- Mostafa Haridy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041739
- Sponsor's protocol ID
- fungal diabetic osteomyelitis
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17093942Reiber 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.
PubMed 1605439Nicolau 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.
PubMed 20093545Hill 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.
PubMed 10326843Mutluoglu 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.
PubMed 23384323Aragon-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.
PubMed 18719880Faglia 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.
PubMed 23413061Eneroth 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.
PubMed 10764999Lipsky BA. Osteomyelitis of the foot in diabetic patients. Clin Infect Dis. 1997 Dec;25(6):1318-26. doi: 10.1086/516148.
PubMed 9431370Grayson 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.
PubMed 7853630Lavery 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.
PubMed 17259493Morales 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.
PubMed 20622159Aragon-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.
PubMed 21219428Alvaro-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.
PubMed 24857262Hunt 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.
PubMed 1395469
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fungal Infection on the Outcome Among Diabetic Patients With Foot Osteomyelitis
- ClinicalTrials.gov ID
- NCT04041739
- Acronym / sponsor ID
- fungal diabetic osteomyelitis
- Conditions
- Diabetic Foot Osteomyelitis
- Keywords
- fungal infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
estimate the percentage of fungal infection in the pathogenesis of diabetic foot osteomyelitis and assess the outcome of patients with fungal diabetic foot osteomyelitis
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic foot osteomyelitis | – | Diagnostic Test: fungal osteomyelitis culture and sensitivityPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All diabetic foot ulcers with osteomyelitis
Key exclusion criteria (2 listed)
- Patients on corticosteroid therapy.
- Patients on long term antibiotic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fungal osteomyelitis culture and sensitivityswabs from ulcer tissue and bone biopsy for culture and sensitivity test and blood sampling | Diagnostic test | diabetic foot osteomyelitis |
Primary outcome
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.
1 secondary outcome
detect response of healing of resistant infected osteomyelitis to antifungal therapy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Background: PubMed 17093942Prompers 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.
- Background: PubMed 1605439Reiber 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.
- Background: PubMed 20093545Nicolau 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.
- Background: PubMed 10326843Hill 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.
- Background: PubMed 23384323Mutluoglu 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.
- Background: PubMed 18719880Aragon-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.
- Background: PubMed 23413061Faglia 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.
- Background: PubMed 10764999Eneroth 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.
- Background: PubMed 9431370Lipsky BA. Osteomyelitis of the foot in diabetic patients. Clin Infect Dis. 1997 Dec;25(6):1318-26. doi: 10.1086/516148.
- Background: PubMed 7853630Grayson 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.
- Background: PubMed 17259493Lavery 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.
- Background: PubMed 20622159Morales 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Haridy study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Osteomyelitis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rowyda El-sayed (01000177067, roro.rody.7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041739, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.