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Introduction |
Welcome to this discussion among podiatrists in which we will discuss current and emerging therapies for treating mild diabetic foot infections. Our primary goals are to understand how you currently treat this population and how a new therapy might impact treatment practices. Panel Intelligence discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, Panel Intelligence expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your Panel Intelligence home page after you've logged in. |
Q1: Current treatment practices |
What is your approach to treating patients with mild diabetic foot infections? Please discuss what therapies you use in what specific patient types. |
Panelist 2: A history of initial ulceration or injury to the foot is taken which usually precedes infection along with medical hx (glucose control, arterial blood flow, sensory evaluation). If a very mild infection in a well controlled patient- c&s, broad spectrum antibiotic, topical antibiotic, warm compresses. In a patient with pvd,neuropathy, poor control-above plus x-ray and omit warm compresses with daily office visits until infection is resolved |
Panelist 9: Paramount to treating any infection would be understanding the etiology. A general rule of treating mild diabetic foot infections would be debridement of all non viable, necrotic tissue in a patient with palpable pulses, offloading pressure with surgical shoe or boot, x-rays, topical wound care based on wound characteristics (macerated, dry, granular, fibrotic), deep culture of any purulence encountered and initial antibiotics such as Bactrim or Keflex. Follow-up in clinic in 2-3 days |
Panelist 11: A COMPLETE history first. Including medications, how well DM is controlled, Vascular status, etc. Etiology of ulcer (injury, etc). Systemic symptoms (fever, chills, etc).A thorough exam is a must: appearance of ulcer, depth, size, necrosis, fluctunace, probing or not to bone (this is being debated now in academic community, but I feel it is still very important), purulence, odor, etc, etc. Vascular status, hand doppler if necessary. Neurological status. X-rays, if warranted (deep ulcer, severe cellulitis, compromised vascular status, etc.)Obtain temperature, pulse, respiration, B/P, etc. Depending on the above, will probably get a deep tissue culture (not a superficial swab, unless overt purulence is noted).If hospitalization is not called for, will debride ulcer in office. Start broad spectrum antibiotics (Augmentin, Keflex). Wound care: irrigate with Sterile normal saline and apply Bactroban or Silvadene BID. Offload the ulcer area, if necessary. Will follow in the office in 2-3 days. Patient to call if infection gets worse. |
Panelist 8: culture wound, debridement of wound, broad spectrum antibiotics if think infection, radiographs, off loading if weight bearing area, consult about recent labs and blood work |
Panelist 8: culture the wound, Debridement the wound, broad spectrum antibiotics. If the wound has necrotic tissue may use enzymatic debridement, if wound has small amount devatlized tissue with pink granular base may use something with growth factor or acellular matrix material |
Panelist 10: Skin or skin related mild diabetic infections are evaluated in office for possible deep tissues involvement not inclusive to osteomyelitis, abscess, gas, etc... A set of X-rays are done of the involved foot or leg and clinical evaluation is carry on like any other infectious evaluation. Then antibiosis started with augmentin, Cipro, Dicloxazillin or similar. Insurance dictates antibiosis rational as long as is indicated, etc. |
Panelist 7: I clinically evaluate the situation on a case by case basis. I physically examine the wound including debridement if necessary. X-rays if necessary. Take a culture swab, if necessary (most mild infections I do not). Assess patients overall blood sugar control and other pertinent medical history (PVD, nutrition status, etc.) Assess if offloading is necessary. Start them on prophylactic antibiosis. Start them on local wound care depending on nature of wound. Finally assess home support system and compliancy. |
Panelist 1: If it is a mild infection, I consider soaks or wound topical cleaners. In most cases a topical antibiotic is enough. If the situation is slightly more complicated then a simple antibiotic by mouth may also be indicated. |
Panelist 16: Appropriate debridement of nonviable tissue and lavage. Topical antibiotic or silver dsg. |
Panelist 5: Oral antibiotics with debridement as needed |
Follow-up ALL: Dermacyn meeting needs |
Panelists listed several weaknesses of current therapies, including concerns with antibiotic resistance and compliance the therapy. Do you believe Dermacyn will address these concerns? Please explain. |
Panelist 7: Yes due to its wide spectrum of coverage. Still not sure of compliancy because I based my response on ease of use (patient friendly). I will know more after seeing this product. |
Panelist 11: Dermacyn may indeed help with the resistance problem. However, the compliance is another story. If it can be administered QD--maybe. |
Panelist 8: Yes may help with resistance problems, however compliance is another issue |
Panelist 2: patient compliance should be similar to existing TX, bacterial resistance is always a concern Dermacyn should fare as well as present TX. Concern I have is cost and ins. coverage. |
Panelist 9: I would need more detailed information and experience with the product but these are two very important daily concerns of those treating lots of wounds. |
Panelist 1: Actually no. I do not think antibiotic resistance is a problem, but some patients are non-compliant no matter what is given. It is very difficult to change that. |
Panelist 16: Yes, from the data you have presented, Deracyn appears to fill the void of topical treatment and antibiotic resistance. |
Q2: Strengths and weaknesses of current therapies |
What are the greatest strengths and weaknesses of current therapies? Overall, how satisfied are you with current treatment options? |
Panelist 2: Oral antibiotic therapy is effective in most cases however, I have a concern for emerging resistant bacteria. Therefore treatment options must continually expand to address this issue. |
Panelist 9: Most mild infections resolve uneventfully and the patients do well. Complexity of wound care regimens and compliance are always issues. Multiple dose antibiotics seem to be a problem in our patient population -- any more than bid is usually not accomplished. |
Panelist 11: Most mild infections resolve with appropriate antibiotics and wound care. Offloading may be a problem, as well as compliance and ischemia. |
Panelist 10: There are a wide spread choices for antibiotic therapy and wound management as well as vascular treatment protocols for PVD. This is per se the strengths. The weakness is that most insurance coverages will cover basic necessities and do not cover a wide range of choices for infection control / irradication, wound management, etc... |
Panelist 7: Current strengths: great broad spectrum coverage of newer antibiotics with fewer side effects and cases of toxicity, newer ointments and dressings do more (promote growth, kill superficial infections, absorb drainage, etc). easier application and willingness of compliancy for patients and physicians Weakness: cost of a lot of the more advanced products are not affordable to everybody including minimal insurance coverage, still have to use multiple products to achieve results in certain situations driving cost of care up and losing compliancy Overall pretty satisfied but interested in seeing where the future lies in wound care |
Panelist 1: I am concerned with the overuse of antibiotics. Many of the current therapies are still sufficient and if physicians would use some of the older tried and proven antibiotics on the market we may stop the mutation of the newest antibiotics. By doing this the newer antibiotics will be effective when really needed. |
Panelist 8: Coverage with best antibiotic coverage, however seeing increasing about of community acquired MRSA which is a great concern |
Panelist 16: strengths: increased knowledge of appropriate tx by practitioners. Access to healthcare Weakness: patient compliance increased resistance of bacteria to abx |
Panelist 5: Many clinician are too liberal with oral antibiotics and I feel this contributes to resistance Satisfied |
Q3: Awareness of Dermacyn |
Have you heard of Dermacyn, a topical product manufactured by Oculus using its Microcyn technology? If so, what have you heard about this product and if you have used it, what has been your experience with this product? Note: Product currently has 510k approval for debridement. |
Panelist 2: I have not heard about this product |
Panelist 9: I may have seen an ad in a magazine but I must admit that I am not familiar at all with the product. |
Panelist 11: I am not aware of this product. |
Panelist 10: No experience with this product. Have not heard about it. |
Panelist 7: Heard of the product and seen in ads of our medical journal, but never used |
Panelist 1: Heard nothing. |
Panelist 7: heard of it through medical journals but never have used |
Panelist 8: I have not heard of this |
Panelist 16: I recently learned of Dermacyn at a wound meeting but have not used it. |
Panelist 5: Never heard of it |
Please click here to review product information (See Appendix A) |
Q4: Reaction to profile |
Based on the information presented, what is your impression of Dermacyn? Does this product fill any gaps in current treatment options? What do you see as this products greatest strengths and weaknesses? |
Panelist 2: I have a favorable impression of this product. Can be used as first line of tx for high risk diabetics. Strengths include antibiosis, debridement, promotes healing{granulation).Of course the weakness will be cost and ins. coverage |
Panelist 9: It seems like a good product. I would be curious if this was the only product used in the case study or as an adjunct. Strengths seem to be use in multiple stages of treatment and antibiotic against resistant strains. There was no info about ease of use, cost, etc. |
Panelist 11: Seems like an interesting treatment option. Would be interesting to see the exact spectrum of the medication, cytotoxicity, double blind clinical trial is always a plus. The cost and insurance coverage is important. What is the method of application, frequency? Can it be combined with other topical therapeutic modalities: Prisma, Promogran, Silvercell, etc. |
Panelist 10: Great product; need my own clinical experience on it, and cost / insurance coverage on my practice area. |
Panelist 10: Strengths; non-invasive / easy to apply by para-professional / wound care nurse, etc... |
Panelist 7: Interesting product, need more clinical pics and outcomes but overall initial presentation sparks interest. Fills gaps by covering a lot of modalities with one product. Strength: previous statements, weakness: and the cost is?...not sure yet without experience of use. |
Panelist 1: The information given is interesting but still not enough data or clinical information to make any decision. If the product performs as indicated, it would hopefully solve a problem of getting oral antibiotics to the wound when circulation does not support the use of the oral antibiotic. Greatest strength is the ease of delivery. The weakness could be the targeting of healthy tissue at the same time. I am not sure if Dermacyn is tissue cellular specific. |
Panelist 8: Yes, I think that this looks good. I would very much like to be able to try this product. The benefit of possible strength is or the potential to save a limb. |
Panelist 16: Overall, favorable. Cost is a factor as well as ease of use and ability to obtain the product. Are the insurance companies going to reimburse for it? |
Panelist 5: Favorable, yes it does, it can be used as an adjunct treatment. I like that it is approved elsewhere |
Click here to review clinical trial information (See Appendix B) |
Q5: Reaction to trial design |
What is your impression of the clinical trial design presented? What is your impression of the treatment arms and endpoints? As presented in the slides: Goal: defining the primary/secondary endpoints for pivotal study Design: open label, comparative controlled study • 3 arms (Microcyn (n=15-20), Saline solution + Oral Levofloxacin (n=15-20), Microcyn + Oral Levofloxacin (n=15-20) • Treated for 10 days and 14 days follow-up Outcomes: Clinical infection cure and improvement, microbiologic success, safety |
Panelist 2: Trials appear to be acceptable in both design and treatment parameters. |
Panelist 9: I think 25 - 30 patients in each group would be better. I also question the use of Levofloxacin -- that would not be my first choice drug for mild diabetic foot infections. Any cultures to be taken? How is "microbiologic success" defined? |
Follow-up ALL: Sample size |
One of you mentioned larger sample sizes would be more appropriate (25-30 in each group versus 15-20); do others agree? Please explain. |
Panelist 7: Yes, I agree. |
Panelist 11: Large sample sizes are always a plus. Both doctors and patients appreciate this and tend to be more loyal to the product. |
Panelist 8: Yes I agree also |
Panelist 2: I agree larger sample size would give more weight to efficacy of this drug. |
Panelist 9: More patients is always better. I think 10-15 would cause some skepticism and criticism whereas 30 is more respectable. |
Panelist 1: Larger sample sizes are not the issue. I would rather give a patient a small starter followed up with an Rx. Larger samples simply gives the patient something for free and the old theory that something for nothing is often worth nothing will hold true. Patients need to purchase more of the product so by doing so will make them not want to waste money so a patient is more apt to use a product that cost money out of the pocket. |
Panelist 16: It seems like the trial is statistically significant though I don't recall the P values for the studies. I don't think that the size of the trial is too small. |
Panelist 7: Sounds like a good way to test drug and be able to follow clinical outcomes |
Panelist 1: I wasn't overly impressed with the slides. Full clinical reports need to be reviewed further for me to make an informed decision. Outcomes appear on the surface to be sufficient, but I would like more date before making a strong decision |
Panelist 8: Both clinical trial design and arms and endpoints look ok |
Panelist 16: I'm curious why you choose levaquin and not something more suitable for gram (+). |
Follow-up ALL: Comparison product |
Several of you mention using levofloxacin as a comparison is a trial design weakness. What do you suggest should be used, and why? |
Panelist 7: Something more first line-diabetic would be Augmentin, Flagyl, or 4th Generation Cephs. These have a tendency to have better overall comprehensive coverage. |
Panelist 11: please see my original response |
Panelist 8: maybe consider this along with a broader drugs as well is another option |
Panelist 2: this antibiotic is typically not a first line tx choice, such as keflex, augmentin. I would like to see how Dermacyn does against other topicals without the effect of an oral antibiotic |
Panelist 9: Again, Levofloxacin is not my first choice for mild infections. Keflex would be a better choice in my opinion. |
Panelist 1: Ulcers are often antibiotic specific. Not all ulcers have the same form or level of bacteria therefore a study with only one antibiotic type is not sufficient. Various antibiotic studies should be performed so a comparison can be made between more than one drug. |
Panelist 16: Levaquin has poor coverage of gram positive bacteria, specifically Staph. aureus being more prone for Penicillin resistance. A broader spectrum oral abx like Keflex or Augmentin may be a better choice. |
Panelist 16: see my above response the computer (or I) didn't register it |
Panelist 11: The design of the double blind study looks OK, but, of course we will need to see the details. Comparing to levofloxacin is somewhat surprising, since this is not a drug of choice for empiric diabetic foot infection. Also, would be nice to compare it to other topicals, like Silvadene, Bactroban, Polysporin, etc. |
Panelist 5: I don't understand much of the much of the terms |
Q6: Impact of results |
Will the Phase 2 results, if outcomes are positive, will this be sufficient for you to use this product? Why or why not? |
Panelist 2: no, should proceed to phase 3 even though this appears to be a very promising product |
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