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Dfi v0.95
 

Dfi v0.95

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  • Prevalence 25%Infection is a frequent (40%-80%) and costly complication of these ulcers and represents a major cause of morbidity and mortality.DFI account for most common cause of diabetes-related hospital admission and could lead to lower-limb amputation. Most infections involved soft tissue but 20% of patients with foot infection had bone culture-proven osteomyelitisA recent report estimated that the risk of hospitalization and lower-extremity amputation was ≈ 56 and 155 times greater for diabetic people who had a foot infection than for those without, respectivelyRisk factors for foot infections in individuals with diabetes.Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BADiabetes Care. 2006 Jun; 29(6):1288-93.1. Review Preventing foot ulcers in patients with diabetes.Singh N, Armstrong DG, Lipsky BA JAMA. 2005 Jan 12; 293(2):217-28.2.Resource utilization and costs associated with the treatment of diabetic foot ulcers. Prospective data from the Eurodiale Study.Prompers L, Huijberts M, Schaper N, Apelqvist J, Bakker K, Edmonds M, Holstein P, Jude E, Jirkovska A, Mauricio D, Piaggesi A, Reike H, Spraul M, Van Acker K, Van Baal S, Van Merode F, Uccioli L, Urbancic V, RagnarsonTennvall G3.Diabetologia. 2008 Oct; 51(10):1826-34.Review Unresolved issues in the management of ulcers of the foot in diabetes.Jeffcoate WJ, Lipsky BA, Berendt AR, Cavanagh PR, Bus SA, Peters EJ, van Houtum WH, Valk GD, Bakker K, International Working Group on the Diabetic FootDiabet Med. 2008 Dec; 25(12):1380-9.4.Photo: http://www.google.com/url?sa=i&rct=j&q=diabetic%2Bfoot%2Bulcer&source=images&cd=&cad=rja&docid=6t4SXUVElEAohM&tbnid=rkZrLwsogIBPwM:&ved=0CAMQjhw&url=http%3A%2F
  • Benjamin, L. 2012 Infectious Diseases Society of America Clinical Practice Guidelines for the diagnosis and Treatment of Diabetic Foot Infections. March 2012
  • Osteomyelitis risk factorsAppearance of a swollen, deformed red toe (sausage toe)Bone visible or palpable on probingInfected ulcer with an erythrocyte sedimentation rate of more than 70mm per hourNon-healing ulcer after a few weeks of appropriate care and off-loading of pressureRadiologically evident bone destruction beneath ulcerUlcer area greater than 2cm2 or more than 3mm deepUlceration presents over bony prominences for more than two weeksUlceration with unexplained leukocytosisLipsky BA, Berendt A, Deery HG, et al., for the Infectious Diseases Society of America. Diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2004;39(7):885-910Photo: http://www.google.com/url?sa=i&rct=j&q=osteomyelitis+diabetes&source=images&cd
  • Benjamin, L. 2012 Infectious Diseases Society of America Clinical Practice Guidelines for the diagnosis and Treatment of Diabetic Foot Infections. March 2012
  • May be we do not need this slideLipsky BA. A report from the international consensus on diagnosing and treating the infected diabetic foot. Diabetes Metab Res Rev. 2004;20 Suppl 1:S68–S77.
  • Most DFIs are polymicrobial, with aerobic gram-positive cocci, especially staphylococci, as the most causative organisms. Aerobic gram-negative bacilli are frequently copathogens in infections that are chronic or follow antibiotic treatmentObligate anaerobes may be copathogens in ischemic or necrotic wounds. Photo = http://everythingconspired.blogspot.com/2013/02/the-black-budget-and-killer-microbes.html
  • 1.Photo: http://www.google.com/url?sa=i&rct=j&q=wound%2Bcare%2Bdiabetic%2.Lipsky BA. Medical treatment od diabetic foot infections. Clin infect Dis 2004.
  • Photo: http://www.google.com/url?sa=i&rct=j&q=antibiotic&source=images&cd=&cad=
  • These are peer reviewed journal articlesThe articles are published online in Wiley Online Library having to meet certain criteria and is therefore reputableThe title is unbiased and states that the article is a systematic review of interventions for the management of infections in the diabetic foot. There is some conflict of interest between the authors. B.A. Lipsky has been a consultant for Merck, Pfizer, Cubist, DiPexium & J&J. A. R. Berendt was a visiting professor at University of Washington representing Pfizer. E. Senneville was an investigator in the EU-CORE database study by NOVARTIS. The sponsor does not have a vested interest in the outcomes.
  • The SIGN (Scottish Intercollegiate Guidelines Network)method used in this study was not detailed and did not accuarately explain what criterion was used to determine quality of the studyIn this systematic review, p-values were given for each study, however, this information is not sufficient to analyzewhether the study used an appropriate method of testing
  • The SIGN method used in this study was not detailed and did not accuarately explain what criterion was used to determine quality of the studyIn this systematic review, p-values were given for each study, however, this information is not sufficient to analyzewhether the study used an appropriate method of testing
  • * Information regarding statistical tests used for each study was not included. The only information that could be derived was whether the results were statistically significant or not from the p values and data given. • SIGN scores rated each study based on its design quality. There was no statistical assessment of the data across the studies, or description of each studies’ design. • The scores were provided without discerning what qualifies as high quality with low bias (++) vs. well conducted with low bias (+), only that the researchers had reached an agreement for the ratings.
  • * Information regarding statistical tests used for each study was not included. The only information that could be derived was whether the results were statistically significant or not from the p values and data given. • SIGN scores rated each study based on its design quality. There was no statistical assessment of the data across the studies, or description of each studies’ design. • The scores were provided without discerning what qualifies as high quality with low bias (++) vs. well conducted with low bias (+), only that the researchers had reached an agreement for the ratings.

Dfi v0.95 Dfi v0.95 Presentation Transcript

  • By: Flora Blumin, Melissa Connell, Srikanth Venkanhagari, Hae Yoon, John Chamoun, Jagrutkumar Vyas, Marissa Egipciaco, Dan Do, Camille Zambrana, Jitenkumar Nathani, Kimberly Regis and Michael Ruden A systematic review of the effectiveness of interventions in the management of infection in the diabetic foot
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • • Lifetime risk of developing foot ulcer in DM pts: 15- 25% • Frequency of infection: 40%-80% • DFIs account for most common cause of diabetes- related hospital admission • Most infections involved soft tissue; however, ~ 20% progress to osteomyelitis Diabetic Foot Infections (DFIs)
  • • High glucose levels in the blood provide nutrients for microorganisms to proliferate • High glucose levels also affect nerve conduction, leading to diabetic neuropathy • DFI typically originate as a wound which goes undetected due to neuropathy Diabetic Foot Infections
  • •Skin and Soft Tissue infection • Early recognition of the area and tissue involvement could prevent the progression of the infection • Osteomyelitis • Common yet serious complication associated with DFI • Delay in diagnosis leads to increased risk for amputation Diabetic Foot Infections
  • •Presence of infections: ≥ 2 • Carlor (heat), Rubor (redness), Tumor (swelling), Dolor (pain) •Infections classification: • Mild (superficial and limited in size and depth) • Moderate (deeper or more extensive) • Severe ( accompanied by systemic signs or metabolic perturbations) Diabetic Foot Infections
  • International consensus on the diabetic foot classification of foot wound infections Grade 1 • No symptoms, no signs of infection • Lesion only involving the skin (no subcutaneous tissue lesion or systemic disorders) with at least two of the following signs: • Local warmth • Erythema > 0.5 cm - 2 cm around the ulcer Grade 2 • Local tenderness or pain • Local swelling or induration • Purulent discharge (thick, opaque to white or sanguineous secretion) • Other causes of inflammation of the skin must be eliminated (for example: trauma, gout, acute Charcot foot, fracture, thrombosis, venous stasis) • Erythema > 2 cm and one of the findings described above or Grade 3 • Infection involving structures beneath the skin and subcutaneous tissue, such as deep abscess, lymphangitis, osteomyelitis, septic arthritis or fasciitis • There must not be any systemic inflammatory response (see Grade4) • Regardless of the local infection, in the presence of systemic signs corresponding to at least two of the following characteristics: • Temperature > 39°C or < 36°C • Pulse > 90 bpm Grade 4 • Respiratory rate > 20/min • PaCO2 < 32 mmHg • Leukocytes > 12 000 or < 4 000/mm3 • 10% of immature leukocytes
  • •Polymicrobial: •Aerobic gram-positive cocci (i.e staphylococci) •Aerobic gram-negative bacilli: chronic or post treatment •Obligate anaerobes: ischemic or necrotic wounds Diabetic Foot Infections
  • •Appropriate antibiotic therapy •Surgical drainage •Debridement and resection of dead tissue •Appropriate wound care •Correction of metabolic abnormalities Diabetic Foot Infections
  • • Clinically uninfected wounds should NOT be treated with antibiotic therapy • Clinicians select an empiric antibiotic regimen on the basis of the severity of the infection • Mild-moderate: antibiotic naïve aerobic GPC coverage • Severe: Broad spectrum empiric antibiotic therapy, pending culture results • Empiric therapy for Pseudomonas aeruginosa is usually unnecessary except for high risk • Empiric therapy to MRSA indicated with prior history of MRSA Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • •Title: A systematic review of the effectiveness of interventions in the management of infection in the diabetic foot •Authors: E.J. G. Peters, B.A Lipsky, A.R. Berendt, J.M. Embil, L.A. Lavery, E. Senneville, V. Urbancic- Rovan, K. Bakker, W.J. Jeffcoate •Published in Diabetes/Metabolism Research and Reviews 2012; 28 (Supplement 1): 142-162 Diabetic Foot Infections
  • Article Objective: Conduct a systematic review to compare treatment regimens in the management of diabetic foot infections Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • •Database used: Pubmed and Embase •Inclusion Criteria: •Studies in any language for interventions for treatment of DFIs •Patient over age of 18 years or older patient with DM •Eligible studies: RCTs, case control, cohorts, ITS, CBA •Exclusion Criteria: •Uncontrolled case series, study with historical control and case reports •Studies where patients with DFIs formed part of the total population were excluded if the data for the subgroup with diabetes were not separately described Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • • Methodoligcal quality: Dutch Cochrane Center scoring list • Level of evidence: SIGN • Scoring system: • ++: high quality, low risk of bias • +: well conducted, low risk of bias • - : low quality, high risk of bias Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • •A total of 29 papers were chosen for review based on the inclusion criteria. Later, four papers were identified and added manually to the review. •Of the final 33 papers, 29 were randomized controlled trials and 4 were cohort studies. •A total of 6, 637 patients were enrolled in a total of 33 trials. Diabetic Foot Infections
  • • Blinding: • 10 double blind study • 1 assessor blind • 1 patient blind • 2 investigator blind • 6 open blind study Diabetic Foot Infections
  • • Meta-analysis were not performed due to heterogeneity of: • The study designs • Interventions • Follow-up • Outcomes • The 33 studies were divided into individual topics and the results with p-values were summarized in Appendix B • The researchers provided a descriptive analysis of the results for various topic Diabetic Foot Infections
  • • Early surgical intervention • Health economics • Topical treatment with antiseptic agents • Granulocyte-colony stimulating factor • Procaine plus polyvinyl-pyrrolidone • Hyperbaric Oxygen Therapy • Antibiotic Choice Based on Boney biopsy • Comparison of antibiotic regimens: • Skin and soft tissue infection alone • Skin and soft tissue with osteomyelitis infection Diabetic Foot Infections
  • • Differences found in following studies were statistically significant • Tan et al., Faglia et al., Tice et al., Martinez-de jesus et al., Piagessi et. al., Erstad and Mclntyre et al. and Lipsky et al. Diabetic Foot Infections
  • •Tan et al. • Amputation rate in antibiotic use vs surgical intervention (27.6% vs. 13.0 %) •Faglia et al. • Amputation rate in early vs delayed drainage (1/43 pt vs. 23/63 pt) •Tice et al. • Total cost of hospitalization in Ertapenem vs Zosyn use ($356 vs. $503) Diabetic Foot Infections
  • •Martindez-de jesus et al. • Odor reduction in superoxide vs other disinfectants (100% vs 25%) • Surrounding cellulitis reduction in superoxide vs other disinfectant (81% vs 44%) •Piaggessi et al. • Duration of antibiotic use with Dermacyn vs Povidone (10.1 +/- 6.1 weeks vs 15.8 +/- 7.8 weeks) • Healing rate at 6 month with Dermacyn vs Povidone (90% vs 55%) • Healing time with Dermacyn vs Povidone (10.5 +/- 5.9 days vs 16.5 +/- 7.1 days) Diabetic Foot Infections
  • •Erstad and Mclntyre et al. • Cure rate of symptoms for Cefoxitin vs Unasyn (21% vs 6%) • Total hospitalization day of Cefoxitin vs Unasyn (12 vs 21) •Lipsky et al. • Cure rate in Linezolid vs Augmentin (81% vs 68%) ** • Cure rate in patient without osteomyelitis in Linezolid vs Augmentin (87% vs 72%) ** ** significantly more incidence of anemia, thrombocytopenia and discontinuation of therapy reported with Linezolid. Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation✓ 1 2 3 4 5 6 7 Article Overview
  • •Surgical interventions • Trial design can pose problems • Early surgery is accepted yet the trial evidence to substantiate the benefit is weak • Two studies may had a high chance of bias • Use of SIGN criteria for documenting study quality • Quality of study design vs. study conduct Diabetic Foot Infections
  • •Antimicrobial agents • Number of subjects limits their usefulness • Marred by the use of small and heterogeneous populations • Low score for study design • Poorly described or had a high risk of bias • Various choices of treatment in different countries and settings Diabetic Foot Infections
  • •Important conclusion • Emerging observational evidence of gram negative species • Impact on the selection of antibiotic regimens • Possibility to treat selected patients with DFI in an outpatient setting with oral Abx • No great difference between antibiotic regimens with a broad or narrow spectrum of activity • Short duration of treatment – even with bone infection Diabetic Foot Infections
  • •Future research suggestion • Robust, well designed, comparative trial • Help clinicians make an optimal choice of both empiric and targeted Abx regimen • Choice of specific agents, the route, and duration of administration Diabetic Foot Infections
  • Diabetes Foot Infection Disease State Overview Clinical Applicability Study Design Results Evaluation Methods Discussion/Limitation ✓ 1 2 3 4 5 6 7 Article Overview
  • • No major differences presented in comparison to the current DFI guidelines produced by the IDSA • No difference in using a specific antibiotic agent, route of administration, or duration of therapy in diabetic foot osteomyelitis. • Treatment duration for soft tissue infection ≈ 2 weeks • Mild infections – 1-2 weeks • Moderate to severe infections – 2-3 weeks • Cost effectiveness • Comparison of ertapenem vs. Zosyn (Tice et al.) • Zosyn total costs were slightly higher due to more frequent dosing, including preparation and administering • Comparison of ceftriaxone and metronidazole vs. ticarcillin/clavulanate in skin and soft-tissue infections (Clay et al.) • Potential cost savings of $61 per patient treated with ceftriaxone and metronidazole vs ticarcillin/clavulanate Diabetic Foot Infections
  • Changes to practice settings are not recommended at this time Diabetic Foot Infections
  • THANK YOU!