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__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
The Following User Says Thank You to Craig Payne For This Useful Post:
Still not a great deal of solid evidence is there!
I'll grill the Endocrinologists and see what they have as I'm sure there should be something in the Diabetologica Journal. I think it just demonstrates that although Diabetic Foot Complications are the main reason a person with Diabetes will end up in hospital, there's not as much emphasis on getting those treatments right as there is for e.g. blood glucose, cholesterol, blood pressure etc.
One reason for this in the UK is that the money for the GPs is in getting those other levels down below a certain level, whereas, although it is regularly quoted about how expensive amputations are, there's no money in their prevention!
Press release Basilea Announces Positive Phase III Results for Ceftobiprole, its First-In-Class Anti-MRA Cephalosporin
Quote:
BASEL, Switzerland, March 2, 2006 (PRIMEZONE) -- Basilea Pharmaceutica Ltd. announces today positive results for its first comparative phase III trial with ceftobiprole. Ceftobiprole showed a high cure rate and was safe and well tolerated. This first-in-class anti-MRSA broad-spectrum cephalosporin is partnered with Cilag AG International, a Johnson & Johnson company.
"These exciting results are a very important and a positive step forward for Basilea and our partner, Cilag AG International. Ceftobiprole has performed consistently in line with our expectations to date. This positive trial is the first of a series of ongoing registration studies designed to demonstrate the effectiveness of ceftobiprole. Our goal is to bring this product to market as soon as possible because patients with serious hospital infections are in need of new treatment options," said Dr. Anthony Man, Basilea's CEO.
The phase III STRAUSS study (Study of resistant Staphylococcus aureus in skin and skin structure infections) demonstrated a high cure rate. In this study targeting Gram-positive infections 397 patients were treated with 500mg ceftobiprole and 387 patients with 1g vancomycin; both groups were treated twice daily for 7-14 days. Statistical non-inferiority was achieved with 93.3% of patients clinically cured on ceftobiprole, and 93.5% of patients treated with vancomycin. Over 25% of microbiologically evaluable patients were confirmed with methicillin-resistant Staphylococcus aureus (MRSA) infections. The ceftobiprole response rate in infections caused by MRSA was 91.9% compared with 90.0% for vancomycin. Adverse events were comparable between the two treatment groups.
"MRSA is a major cause of mortality and morbidity in severe hospital infections and is of increasing concern in the community. While ceftobiprole has a broad spectrum of activity, this study was specifically designed to highlight the Gram-positive activity, including MRSA. The positive results of this first, large-scale study are an important milestone toward registration of ceftobiprole," commented Dr. Rienk Pypstra, Chief Development Officer of Basilea.
The FDA granted ceftobiprole fast-track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species and for a second indication in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole is currently also in a second complicated skin infection trial (STRAUSS 2) targeting both Gram-positive and Gram-negative bacterial infections, [b]including patients with diabetic foot infections and in phase III clinical trials in nosocomial pneumonia (CHOPIN studies).
However, there was also this in the same issue: Systematic review of antimicrobial treatments for diabetic foot ulcers. Diabet Med. 2006 Apr;23(4):348-59
Quote:
Abstract Background Foot ulcers in diabetes are associated with increased mortality, illness and reduced quality of life. Ulcer infection impairs healing and antimicrobial interventions may cure infection, aid healing and reduce amputation rates. Objectives To systematically review the evidence for antimicrobial interventions for foot ulcers in diabetes. Methods We searched 16 databases, 11 Internet sites, three books, conference proceedings, a journal and bibliographies in November 2002. We included randomized controlled trials (RCTs) or controlled clinical trials (CCTs). Results Twenty-three studies investigated the effectiveness or cost-effectiveness of antimicrobial agents: intravenous antibiotics (n = 8); oral antibiotics (n = 5); topical antimicrobials (n = 4); subcutaneous granulocyte-colony stimulating factor (G-CSF) (n = 4); Ayurvedic preparations (n = 1): and sugar vs. antibiotics vs. standard care (n = 1). The trials were small and too dissimilar to be pooled. There is no strong evidence for any particular antimicrobial agent for the prevention of amputation, resolution of infection, or ulcer healing. Pexiganan cream may be as effective as oral ofloxacin for resolution of infection. Ampicillin and sulbactam cost less than imipenem/cilastatin, G-CSF cost less than standard care and cadexomer iodine dressings may cost less than daily dressings. Conclusions The evidence is too weak to recommend any particular antimicrobial agent. Large studies are needed of the effectiveness and cost-effectiveness of antimicrobial interventions.
EXECUTIVE SUMMARY:: 1. Foot infections in patients with diabetes cause substantial morbidity and frequent visits to health care professionals and may lead to amputation of a lower extremity.
2. Diabetic foot infections require attention to local (foot) and systemic (metabolic) issues and coordinated management, preferably by a multidisciplinary foot-care team (A-II) (). The team managing these infections should include, or have ready access to, an infectious diseases specialist or a medical microbiologist (B-II).
3. The major predisposing factor to these infections is foot ulceration, which is usually related to peripheral neuropathy. Peripheral vascular disease and various immunological disturbances play a secondary role.
4. Aerobic Gram-positive cocci (especially Staphylococcus aureus) are the predominant pathogens in diabetic foot infections. Patients who have chronic wounds or who have recently received antibiotic therapy may also be infected with Gram-negative rods, and those with foot ischemia or gangrene may have obligate anaerobic pathogens.
5. Wound infections must be diagnosed clinically on the basis of local (and occasionally systemic) signs and symptoms of inflammation. Laboratory (including microbiological) investigations are of limited use for diagnosing infection, except in cases of osteomyelitis (B-II).
6. Send appropriately obtained specimens for culture before starting empirical antibiotic therapy in all cases of infection, except perhaps those that are mild and previously untreated (B-III). Tissue specimens obtained by biopsy, ulcer curettage, or aspiration are preferable to wound swab specimens (A-I).
7. Imaging studies may help diagnose or better define deep, soft-tissue purulent collections and are usually needed to detect pathological findings in bone. Plain radiography may be adequate in many cases, but MRI (in preference to isotope scanning) is more sensitive and specific, especially for detection of soft-tissue lesions (A-I).
8. Infections should be categorized by their severity on the basis of readily assessable clinical and laboratory features (B-II). Most important among these are the specific tissues involved, the adequacy of arterial perfusion, and the presence of systemic toxicity or metabolic instability. Categorization helps determine the degree of risk to the patient and the limb and, thus, the urgency and venue of management.
9. Available evidence does not support treating clinically uninfected ulcers with antibiotic therapy (D-III). Antibiotic therapy is necessary for virtually all infected wounds, but it is often insufficient without appropriate wound care.
10. Select an empirical antibiotic regimen on the basis of the severity of the infection and the likely etiologic agent(s) (B-II). Therapy aimed solely at aerobic Gram-positive cocci may be sufficient for mild-to-moderate infections in patients who have not recently received antibiotic therapy (A-II). Broad-spectrum empirical therapy is not routinely required but is indicated for severe infections, pending culture results and antibiotic susceptibility data (B-III). Take into consideration any recent antibiotic therapy and local antibiotic susceptibility data, especially the prevalence of methicillin-resistant S. aureus (MRSA) or other resistant organisms. Definitive therapy should be based on both the culture results and susceptibility data and the clinical response to the empirical regimen (C-III).
11. There is only limited evidence with which to make informed choices among the various topical, oral, and parenteral antibiotic agents. Virtually all severe and some moderate infections require parenteral therapy, at least initially (C-III). Highly bioavailable oral antibiotics can be used in most mild and in many moderate infections, including some cases of osteomyelitis (A-II). Topical therapy may be used for some mild superficial infections (B-I).
12. Continue antibiotic therapy until there is evidence that the infection has resolved but not necessarily until a wound has healed. Suggestions for the duration of antibiotic therapy are as follows: for mild infections, 12 weeks usually suffices, but some require an additional 12 weeks; for moderate and severe infections, usually 24 weeks is sufficient, depending on the structures involved, the adequacy of debridement, the type of soft-tissue wound cover, and wound vascularity (A-II); and for osteomyelitis, generally at least 46 weeks is required, but a shorter duration is sufficient if the entire infected bone is removed, and probably a longer duration is needed if infected bone remains (B-II).
13. If an infection in a clinically stable patient fails to respond to 1 antibiotic courses, consider discontinuing all antimicrobials and, after a few days, obtaining optimal culture specimens (C-III).
14. Seek surgical consultation and, when needed, intervention for infections accompanied by a deep abscess, extensive bone or joint involvement, crepitus, substantial necrosis or gangrene, or necrotizing fasciitis (A-II). Evaluating the limb's arterial supply and revascularizing when indicated are particularly important. Surgeons with experience and interest in the field should be recruited by the foot-care team, if possible.
15. Providing optimal wound care, in addition to appropriate antibiotic treatment of the infection, is crucial for healing (A-I). This includes proper wound cleansing, debridement of any callus and necrotic tissue, and, especially, off-loading of pressure. There is insufficient evidence to recommend use of a specific wound dressing or any type of wound healing agents or products for infected foot wounds.
16. Patients with infected wounds require early and careful follow-up observation to ensure that the selected medical and surgical treatment regimens have been appropriate and effective (B-III).
17. Studies have not adequately defined the role of most adjunctive therapies for diabetic foot infections, but systematic reviews suggest that granulocyte colony-stimulating factors and systemic hyperbaric oxygen therapy may help prevent amputations (B-I). These treatments may be useful for severe infections or for those that have not adequately responded to therapy, despite correcting for all amenable local and systemic adverse factors.
18. Spread of infection to bone (osteitis or osteomyelitis) may be difficult to distinguish from noninfectious osteoarthropathy. Clinical examination and imaging tests may suffice, but bone biopsy is valuable for establishing the diagnosis of osteomyelitis, for defining the pathogenic organism(s), and for determining the antibiotic susceptibilities of such organisms (B-II).
19. Although this field has matured, further research is much needed. The committee especially recommends that adequately powered prospective studies be undertaken to elucidate and validate systems for classifying infection, diagnosing osteomyelitis, defining optimal antibiotic regimens in various situations, and clarifying the role of surgery in treating osteomyelitis (A-III).(Table is included in full-text article.).
The CREST guidelgines (clinical resource efficiency spport team) have recommendations for practice and page 16 has the antibiotic recommendations and can be found on their website. http://www.crestni.org.uk/publicatio...betic_foot.pdf
Superficial ulcer:- flucloxacillin 500mg qds or co-amoxiclav 625mg tds for 7-17 days with frequent reassessment.
Deep ulcer:- flucloxaxillin 500mg ds, ciprofloxacin 500mg bd and metronidazole 400mg. Triple therapy regimen, the duration of therapy usually depends on severity but should be considered for 6 weeks.
Deep ulcer plus active cellulitis: regiemen as above but i.v. antibiotics essential, usually based on sensitivity testing.
For patients with a penicillin allergy:- erythromycin 500mg qds or clarithromycin 500mg bd.
Its all on their web site and is usefull as a guideline.
Thanks for this - better than anything else out there, but it has no evidence to back it up unfortunately - perhaps they published their references elsewhere??
Prodigy guidance and NICE state that there is a sytematic reveiw underway at present which should help in the future, but NICE stated this in 2004, and still no sign, so let's hope it's here soon!
Unfortunately, I've already handed-in my non-medical prescribing coursework which I needed it for, but it's good for clinical practice and development of guidelines.
I've asked our mirobiology dept to analyse most commonly found micro-organisms from swabs of DFU's (I know swabs not v.reliable, but still no access to soft tissue biopsy here at the moment), and I'm going to devise our own guidelines hopefully!
The next sticking point is guidance on dressing selection - minefield!!!!!
Diabetic foot infections should always be regarded as serious, and treated vigorously. Culture may be unhelpful because of polymicrobial infections and superficial colonisation but may guide therapy particularly if Staphylococcus aureus or multiresistant pathogens are found. Anaerobic organisms are almost always involved, often with mixed Gram-positive and Gram-negative aerobic organisms. Surgical debridement is often necessary and antibiotic therapy should be effective against the mixed aerobic and anaerobic organisms frequently responsible. Underlying osteomyelitis should be considered. Vascular supply should be assessed.
For mild to moderate infection with no evidence of osteomyelitis, use
metronidazole 400 mg orally, 12-hourly
PLUS
cephalexin 500 mg orally, 6-hourly.
Alternatively, use
amoxycillin+clavulanate 875+125 mg orally, 12-hourly.
For patients with penicillin hypersensitivity, use
ciprofloxacin 500 mg orally, 12-hourly
PLUS
clindamycin 600 mg IV, 8-hourly.
For severe potentially limb-threatening infection, use
piperacillin+tazobactam 4+0.5 g IV, 8-hourly
OR
ticarcillin+clavulanate 3+0.1 g IV, 6-hourly.
Alternatively, and for patients with penicillin hypersensitivity, use
ciprofloxacin 750 mg orally, 12-hourly
PLUS EITHER
clindamycin 900 mg IV, 8-hourly
OR
lincomycin 900 mg IV, 8-hourly.
Depending on the organisms subsequently isolated from deep tissue specimens, other antibiotic combinations may be indicated. The duration of treatment will depend upon the response.
There is also a reference list attached to the site
__________________ Stephen Tucker Eastern Health
Podiatry Manager
Speak to your LOCAL infection control/Pharmacy officers, there will be local guidelines, the bugs involved vary from place to place.
You should also read the numerous articles published by Lipsky, which is research and EVIDENCE based about the use of antibiotics in ulceration in Diabetes.
There have been several published in The Diabetic Foot journal.
I have to say though from clinical experience I would have to agree with tthe last post wrt the antibiotics of choice. Fluclox is not the best choice for Diabetes. See Lipsky.....
The crest guidelines are excellent and are helpful when discussing infection with less experienced practtioners (eg SHOs ect who automatically prescribe Fluclox for every infection).
You should set a protocol with your local diabetes team (and I mean Team) they all need to work together and then get it out to the local GPs to make sure you all sing from the same hymn book.
THis can make a massive difference to the infection rates in Diabetes.
Not sure who your comments are directed to, but I don't agree that the CREST guidelines are excellent, as they are not referenced. Also, we do not have local guidelines and I have read all of Lipsky and used his 'evidence', but I was acutally looking for systematic review / meta-analysis level evidence of which I can assure you, as it brought me just this side of insanity, there is none!
I do work within a 'team' and I am forming local guidance, but local guidance doesn't cut it in acadaemia!
I could easily set out my own guidance, but it would be based mainly on clinical experience and limited research - if NICE can't commit to guidance and specifically says there is none of a specifically high enough level, I would be inclined to agree with them, wouldn't you?
Let's just hope I don't have to fail my Non-Medical Prescribing for the sake of 'no evidence'!
yes I would agree BUT we have to work with whats available.
The crest Guidelines are good (yes I agree not referenced) Have you tried contacting the secretariat for the refernces as it says full refs are available?
This MAY help....! ?
I would guess that there have been systematic reviws because we all work to local protocols. The US would be the only area where this research would be done.
We can all live in hope though.
Good Luck with your Prescribing. I got mine without doing exactly what you have done, so you should be ok.
sAW A PT TODAY IN HOUSE WITH TWO KNEE IMPLANTS AND A ROD IN HIS LEFT TIBIA HIS LEFT FOOT IS HYPERPIGMENTED X-RAY SHOW POOR BONE STOCK POSSIBLE FRACTURES OF SEVERAL METS. TX WITH TWO COURSES OF Ab WITHOUT X-RAY, oH YES NUMB FOOT GREAT PULSE PINS AND NEEDLES ONLY SWELLS WHEN HE WALKS ON IT . rEQUESTED IS A WBC LABELED TcSCAN AN MR WITH CONTRAST(MAYBE A POOR IDEA )AND ESR WBC ARE WNL pT GETTING IV Ab UNASYN . hOW MANY VOTE OSTEO AND HOW MANY CHARCOT
Sounds like Charcot to me as he has swelling,great pulses and loss of sensation.The multiple fractures appear to be the famous "bag of bones"related to Charcot foot.An Xray sounds like a good idea to me.
Robbie, I am glad you agree about the CREST guidelines. I am from N.Ireland and they are evidence based, although now working in Oz and I have found them a great guideline to show the GPs here, as they only ever prescribe fluclox 250mg.
Evidence based practice is always the best practice, and the CREST guidelines are that. Robbie is right in that if you are looking for references, ask the people who have written antibiotic guidelines. There is no point in re inventing the wheel, when it works perfectly well. Just ask for the blue prints!!!!
In the US i have been using the same Ab as in your guide line for the little stuff out side of hospital in house I call My friends in the ID world and let then make the call. If i do admit as a rule of thumb i use unasyn zosyn timentin vanco and rarely ancef something called tigercycline has also poped up as of late .
Tuckersm
Information from the Therapeutic Guidelines Series on Antibiotic Use http://etg.hcn.net.au/ available through the Clinician's Health Channel to all Public Sector employees in Victoria
sorry need that ref looked at site but could not see the wood for the trees so could you find it for me.
Foot infections are a major cause of morbidity in diabetic patients. Staphylococcus aureus is the most important pathogen in mild infections; moderate to severe infections are frequently polymicrobial. Multidrug resistance is an increasing problem in isolates from diabetic feet. Worldwide, up to 30% of patients with diabetic foot infection (DFI) are colonised with methicillin-resistant S. aureus (MRSA), whilst extended-spectrum beta-lactamase-producing Gram-negative bacteria are also common in some countries. This emergence of drug resistance has coincided with the launch or imminent availability of many new antibiotics. Most of these were developed to target multidrug-resistant Gram-positive bacteria, although some have a spectrum of activity that includes Gram-negative bacteria and anaerobes. There is a variable amount of experience with these agents in treating skin and skin-structure infections (SSSIs), especially for DFI. However, at least some have a spectrum of activity and/or pharmacological properties that suggest that they may be of value in managing DFIs. The aim of this paper is to review evidence for the efficacy of new antibiotics in the management of SSSIs, including any data relating specifically to the diabetic foot, and to consider where they might fit into the therapeutic armory against DFI.
PURPOSE: The clinical efficacy of a modified vancomycin dosing protocol with a conventional regimen for managing patients with diabetic foot infections caused by methicillin-resistant Staphylococcus aureus (MRSA) was evaluated.
METHODS: This prospective study was conducted from January 2002 to December 2004 at the diabetic ward of Chang Gung Memorial Hospital-Linkou in Taiwan. All diabetic patients with MRSA-related diabetic foot infections confirmed by wound cultures were enrolled in this study. Patients treated with the conventional protocol (from 2002 to 2003) received vancomycin 10-15 mg/kg (up to 1 g) over 60 minutes every 12 hours if their serum creatinine (SCr) concentration was 0.4-1.4 mg/dL according to the estimation of creatinine clearance (CL(cr)). Patients treated with the modified vancomycin dosing protocol (from 2003 to 2004) received vancomycin according to their SCr level, age, and concurrent gentamicin dosage. Data analyzed included patients' age, sex, body weight, SCr level, CL(cr), serum vancomycin peak and trough levels, vancomycin dosage, treatment period, and duration of hospital stay.
RESULTS: A total of 85 patients were enrolled in this study. The conventional protocol group achieved substantially higher serum vancomycin levels than those recommended by the British National Formulary (BNF). Although the vancomycin dosage in the modified protocol was lower than that in the conventional protocol, trough and peak vancomycin levels remained within the range recommended by the BNF. The duration of hospitalization and treatment did not significantly differ between the two groups.
CONCLUSION: A modified vancomycin dosing protocol for treating diabetic foot infections caused by MRSA was superior to the conventional dosing regimen in achieving therapeutic serum levels of vancomycin.
Re: Evidence base for Antibiotic selection in Diabetic foot ulceration
Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital.
Saltoglu N, Dalkiran A, Tetiker T, Bayram H, Tasova Y, Dalay C, Sert M. Clin Microbiol Infect. 2009 Oct 14. [Epub ahead of print]
Quote:
In this prospective, randomized, and open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-four in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n=30 evaluated) (4.5 g IVq8h) or imipenem/cilastatin (IMP, n=32 evaluated) (0.5 g IVq6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP groups. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Clinical response, the primary outcome, was obtained in 14 (46.7%) patients in Pip-Tazo group and in 9 (28.1%) patients in IMP group (relative risk, RR: 1.6 [95% confidence interval, 95%CI: 0.84-3.25], p=0.130).Two patients in the IMP group and none in the PIP-Tazo group relapsed (RR: 2 [0.94-4.24], p=0.058). Eighty-nine microorganisms were isolated; 38 (42%) were Gram-positive and 51(57%) were Gram-negative. Among patients with positive culture, 47 (96%) had complete and 2 (4%) had partial microbiological response. Microbiological response rates were similar in two groups (p=1.000). The amputation was performed in 18 (60%) and 22 (69%) patients in Pip-Tazo and IMP groups (p=0.739). Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, though statistically non-significant given the sample size studied, we showed that Pip-Tazo is superior to IMP in terms of clinical response rate for the treatment of severe DFI. There was no significant difference between treatment groups with regard to microbiological response, relapse and amputation rates.
Re: Evidence base for Antibiotic selection in Diabetic foot ulceration
Accounting for the Development of Antibacterial Resistance in the Cost Effectiveness of Ertapenem versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in the UK.
Jansen JP, Kumar R, Carmeli Y. Pharmacoeconomics. 2009;27(12):1045-56.
Quote:
Increased antibacterial use is associated with a greater likelihood of reduced effectiveness as a result of resistance development in the future. The objective of this study was to evaluate the cost effectiveness of ertapenem versus piperacillin/tazobactam in the treatment of diabetic foot infections (DFIs) from the UK NHS perspective, accounting for the development of antibacterial resistance over time. A decision-tree model was developed to estimate the cost effectiveness of ertapenem versus piperacillin/tazobactam at different timepoints in the 36 months following introduction of treatment. Development of antibacterial resistance was incorporated in the analysis using a previously published compartment (susceptible-infected-susceptible) model. The development of resistance was a function of the clearance rate of pathogens and the size of the proportion of the population prescribed the antibacterial.The microbiological clearance rate and clinical success rates were assumed to be related and were obtained from the SIDESTEP study. These data included resistant pathogens (either acquired or intrinsic resistance) such as Enterobacteriaceae, meticillin-resistant Staphylococcus aureus, enterococci and Pseudomonas aeruginosa. Model outcomes over time included lifetime QALYs, direct medical costs (year 2006 values) and cost per QALY saved. Clinical efficacy of second-line treatment, direct medical costs and utilities were derived from other existing studies. Probabilistic sensitivity analyses were undertaken to estimate the uncertainty of model outcomes. Costs and QALYs were discounted at 3.5% per annum. The model suggested savings of pound407 (95% uncertainty interval [UI] -337, 1501) per patient when DFIs were treated with ertapenem instead of piperacillin/tazobactam after 1 month's treatment. Probabilistic sensitivity analysis suggested a 91% probability of the incremental cost per QALY saved being within a threshold for cost effectiveness of pound20 000. After 3 years it is expected that the antibacterial resistance profile with piperacillin/tazobactam would increase at a greater rate than with ertapenem. As a result, the cost savings with ertapenem are expected to increase to pound3465 (95% UI 2502, 4564), and ertapenem will additionally result in greater clinical success rates and lifetime QALY savings (1.16; 95% UI 0.46, 2.06). Ertapenem appears to be a cost-saving and possibly an economically dominant therapy over piperacillin/tazobactam for the treatment of patients with DFIs from the UK NHS perspective
Evidence base for Antibiotic selection in Diabetic foot ulceration
Linear Mode
