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Present E-learning Systems

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Hello, my name is Judy LaJoie. I am an Associate Director of Nursing for Wound Care Services at the New York Methodist Hospital located in Brooklyn, New York. Today, I’d like to talk to you about adjunctive therapies in the care of the diabetic foot.

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First, I’d like to talk about the diabetic foot itself. Patients diagnosed with diabetes may see more common risk factors, which include arterial insufficiency, structural deformity, and sensory neuropathy. Risk of lower extremity amputation can be upwards of 40 times higher in a diabetic patient verses a patient without diabetes. Each year, 50-70,000 amputations are performed on people with diabetes in the U.S. So, as you can see this is a growing problem, not only in the U.S. but all over the world.

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Let’s talk about the cost of diabetic foot ulcers. Diabetic foot ulcers are the leading cause of hospitalization among diabetic patients, whether it be for gangrene, osteomyelitis, abscess, and ocellulitius. These wounds are conservatively estimated to cost the U.S. healthcare system over $1 billion per year. The tremendous toll of these ulcers demonstrates the need for better treatments; more comprehensive treatments, that’s where adjunctive treatments may come in. Increased healing time is directly proportional to increased costs. So, if we’re able to use an adjunctive treatment along with standard diabetic foot care, we may be able to decrease treatment time and avoid amputation.

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There are several adjunctive treatments that along with aggressive wound care can help practitioners and patients reach healing goals. Some of the adjunctive treatments that I’m going to talk about today include: compression therapy, hyperbaric oxygen treatment, anodyne therapy, silver therapy, platelet derived growth factors, electrical stim therapy, bi-layered growth factor delivery systems, off loading techniques, nutritional support, and hydrotherapy.

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In the following slides, we will address some of these adjunctive therapies and how they can better help the practitioner heal these problem diabetic wounds and help prevent lower extremity amputation.

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The first adjunctive treatment I’d like to talk to you about today is hyperbaric oxygen therapy. For a moment, first let’s go back and talk about oxygen. Oxygen is a necessity to the proper healing of bodily tissues. Skin, bone, and muscle all need a competent vasculature to help carry oxygenated blood to injured tissues. The use of hyperbaric oxygen helps deliver 100% oxygen under pressure to these damaged tissues. Please keep in mind, the oxygen that we breathe in the normal environment is only 21%. So you can see the use of 100% oxygen is definitely an increase over the norm. The use of this therapy promotes angiogenesis or the production of new blood vessels to help carry oxygenated blood to the injured area. Inflow should be addressed prior to hyperbaric oxygen therapy because if there’s a chance that the patient can be successfully and safely bypassed, that should be done prior to the start of HBO therapy to achieve the most optimal results.

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If you have a patient who may be a candidate for hyperbaric oxygen therapy, they must be very carefully screened to ensure that they will be a safe candidate for therapy. Their screening must include a full past medical history; you'll need to know if they have a seizure disorder, keeping in mind 100% oxygen can reduce a patient's seizure threshold. So if their on any type of anti-seizure medication their levels must be assessed prior to the start of therapy to ensure that their levels are therapeutic. They must be screened for how well controlled third diabetes is. You'll have to know this to ensure that there won't be a risk of hypoglycemia while in the chamber. There are some absolute contraindications to hyperbaric therapy; one of them is an active pneumothorax. Any patient with an active pneumothorax can not be treated. The pneumothorax needs to be resolved and then patient can be reassessed. Other contraindications to be aware of is if the patient is being treated with Doxorubicin for Adreomycin, if they’re being treated with Antabuse, Sysplatinum, and Mafinideacitate, or Sulfamylon; a through intake history must be performed to ensure that the patient can be safely treated.

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Once your patient has been noted to be a good candidate for HBO therapy, it is important to explain to them that this therapy is the daily treatment usually given on a Monday to Friday basis; normal treatment time is 1 hour 50 minutes. The number of prescribed treatments can be anywhere from 10 to 60 treatments, depending on what diagnosis you are treating the patient for. Usually, in the diabetic foot, it can be anywhere from 40 to 60 treatments. Treatment can be provided in either a monoplace, which is a one-person chamber or in a multi-place, which can hold several people at the same time. Please be mindful that there are different products on the market that market themselves as limb chambers where you would put only your foot, your leg, or an arm in the chamber. Please be aware that these products are not recognized by Medicare. In order for hyperbaric therapy to be effective, the entire body must be in the chamber and the patient must be breathing in the 100% oxygen under pressure for angiogenesis to be precipitated.

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Now, let's move on to platelet derived growth factor therapy. The Science and Technology Dictionary defines PDGF as a glycolytic protein released by platelets and other cells that stimulates growth of cells of Mesenchymal origin. For example, bone, cartilage, vascular tissue, and connective tissue. Currently, there is an exogenous PDGF gel on the market, available by prescription that demonstrates biological activity similar to that of endogenous PDGF. This exogenous PDGF medication is called Regranex. Regranex is available by prescription as a gel in a 15 gram tube. The amount used varies upon the size of the ulcer’s area. The manufacturer’s guideline suggests the dosage to be used; this should be calculated by using length of wound times with of wound times 0.6. Using this calculation, each square centimeter of ulcer will require a 0.25 cm length of gel squeezed from a 15 gram tube. The dosage should be readjusted weekly depending on healing progression.

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The way that platelet derived growth factor therapy works is that the gel promotes recruitment and proliferation of chemotactic cells including monocytes and fibroblasts, necessary for stimulation of a variety of wound healing process and aiding in the creation of granulated tissue. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief, and infection control this gel increases the incidence of complete healing of diabetic ulcers. The dressing is placed once daily and after 12 hours, the dressing is removed, excess gel is removed with sterile normal saline and a normal saline moistened gauze is applied to the wound bed. This gel should not be used in patients with a known hypersensitivity to the gel or for a neoplasm.

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I’d now like to talk about compression therapy as an adjunct treatment for the diabetic foot ulcer. Venous stasis disease can further complicate a diabetic foot ulcer. Extra venous congestion in the foot needs to be addressed as this excess fluid can be a hindrance to wound healing. Careful consideration to arterial inflow must be addressed prior to the start of any level of compression therapy. You must be sure that the patient has a fairly competent arterial system so that when a compression device is placed that arterial insufficiency will not occur.

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As we mentioned in the slide prior to this one, before starting any type of compression therapy, you need to assess the arterial inflow. One fairly simple way of determining arterial flow is the Ankle Brachial Index. This exam compares the brachial blood-pressure to the pressure in the posterior tibial artery. The measurements are calculated and then assigned a ratio. An ABI index of 1.0 is considered normal, and between 0.8 and 1.0 is indicative of venous disease, while less than 0.8 usually indicates an arterial component. It is not uncommon to see non-compressionible arterial walls in the diabetic patient.

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Once arterial inflow has been addressed and is noted to be adequate then there are several different compression therapies that can be utilized. Please keep in mind that the patient should also not be in any acute stage of CHF prior to the start of the therapies that they may develop volume overload as a result of this compression therapy. We're going to talk about four different types of compression therapy. They are the four layer compression wrap, lymphedema pump's, compression garments, and non-elastic wraps.

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The first compression device I’d like to talk about is the Four-Layer Compression Wrap. These wraps provide 30-40mm of mercury to the extremity. They must be applied from the toe to the knee for adequate compression, keeping in mind that we’d like to keep a normal conduit going from the base of the toe to the knee to try to push out the excess fluid. They need to be re-applied on a weekly basis; keeping in mind that they may need more frequent changes early in the therapy if there’s a large amount of exudates. Wound care for the diabetic ulcer underneath the compression wrap must be therapeutic for 7 days, something like a long active silver dressing. Please keep in mind that good surrounding skin care is very important, as skin underneath the compression wrap may become macerated, if there’s a large amount of exudate or may become dry if the skin has become dried from the wrap being on for a week.

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Now, let’s talk about lymphedema pumps. These pumps utilize what’s called pneumatic medicine. Pneumatic medicine is a non-invasive utilization of air compression therapy to treat venous congestion. A special garment resembling a giant stocking is attached to a pump. The stocking is placed on the affected extremity and cells in the stocking gradually fill from toe to thigh to help relieve venous congestion and bring fluid back into the venous system. This pump is used daily, usually for one hour once or twice per day.

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Compressive Garments: The garments may be obtained at a medical/surgical supply store with a physician’s prescription. They usually provide from anywhere between 10-40mm of mercury pressure to relieve venous congestion in the lower extremity. This is a maintenance therapy for life. Once patient’s have been put into stockings, they have to be educated that this is not a short term fix. These stockings need to be placed on before getting out of bed in the morning and they need to be removed when going to bed at night, Having two pairs if these stockings is really ideal for patients because they’re able to wear one pair while the other pair is washed. There are all different types of compression garments on the market. If the patient has an active ulcer they have compressive garments that come with an inner liner so the dressing can be placed; the liner can be placed on top and the compressive garment on top of that so that the compressive garment doesn’t have any exudate track to it. They also come with zippers for those people who have arthritic hands and find it difficult to place these compressive garments on. They also make all different kinds of gadgets to make it easier for these compressive garments to be put on. They come custom made for different sizes. If your patient doesn’t fit the small, medium, or large size, there are compressive garments out there for everyone.

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Non-elastic Bandages: These bandages, also known as Unna Boot, are also used to reduce venous congestion. These paced bandages are usually impregnated with either zinc or calamine lotion and help to both reduce the level of edema and reduce local irritation as a zinc or calamine can be soothing to the skin. The same care must be taken to ensure the patient has adequate arterial flow prior to the placement of the Unna Boot.

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Anodyne Therapy: Anodyne therapy system is an FDA-cleared infrared medical device that increases circulation and decreases pain. The device employs illumination to apparently increase the localized levels of nitric oxide. Tests conducted demonstrate that the near infrared photo thermal energy delivered by the anodyne therapy system; can increase localized microcirculation by as much as 3200% after just 30 minutes.

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Anodyme therapy should not be used directly over any active malignancy; over or near the womb of a pregnant woman; or directly over a topical heating agent, such as Bengay, Icy Hot, or Capsacin. Completely remove these agents before applying Anodyme.

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Now I’d like to talk about one of the hot topics in wound care these days. Silver Therapy: Silver therapy is a known broad spectrum antimicrobial and is effective against many micro-organisms including resistant strains of MRSA and VRE as well as fungal overgrowth. There is no known resistance in nature to silver. The release of ionic silver into a wound bed helps to control the bio-burden of the wound. The bio-burden being the layer of organisms in the wound they being may be preventing the wound from healing. Since many chronic wounds are stunted by critical colonization, silver controls the bio-burden of the wound environments so that new, healthy granulation tissue can begin to form.

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Silver products for wounds have exploded on the wound care market. Today they come in all shapes and sizes. You can’t pick up any wound care journal without seeing at least 5 or 6 ads for different companies promoting their silver product. Silver can be found in collagen matrixes, in alginates for highly exitative wounds in powders, in hydrogets for dry wounds. Depending on the wound characteristics. An appropriate silver can be found and applied to the wound. There are enough products on the markets these days to cover all of the basics as far as wound care is concerned.

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Electrical stimulation therapy or E-stim: Electrical stimulation is indicated for chronic wounds, including pressure, diabetic, arterial, and venous ulcers. Negative polarity administered to the wound by electrical stimulation increases granulation and fibroblast activity, which have been documented to facilitate wound healing. It has been reported that electrical stimulation plus standard wound care has closed pressure ulcers in spinal cord injury patients. Negative polarity has been shown to enhance the healing of venous leg ulcers by increasing fibroblast activity and capillary density in patients who did not respond to standard wound case alone.

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Electrical stimulation affects the biological phases of wound healing. We’re going to take a look at how it affects the inflammatory phase. In the inflammatory phase it initiates the wound repair process by its effect on the current of injury, increases blood flow, promotes phagocytosis, enhances tissue oxygenation, reduces edema perhaps from reduced microvascular leakage, attracts and stimulates fibroblasts and epithelial cells, stimulates DNA synthesis, controls infection. HVPC proven bacteriocidal at higher intensities than use in clinic and may not be tolerated by patients. Solubilizes blood products including necrotic tissue.

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Depending on the healing phase and the patient, the settings are different. There are different protocols for different stages of healing. Please follow manufacturers guidelines based on current wound progression.

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Now I’d like to talk about bi-layered growth factor delivery systems. A current commercial product on the market today is called Apligraf. Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full thickness neuropathic diabetic foot ulcers of greater than 3 weeks duration, which have not adequately responded to conventional ulcer therapy and which extends through the dermis but without tendon, muscle, capsule, or bone exposure.

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If you’re wondering when should you consider using Apligraf. I’d like to break for a minute and show you what we already know about apligrafs. In a large scale clinical trial, Apligraf was shown to heal more diabetic foot ulcers faster than conventional therapy alone. In a study that was performed by 12 weeks of treatment, 56% of diabetic foot ulcers treated with Apligraf were 100% closed compared to 39% of ulcers treated with conventional therapy. Conventional therapy was listed as debridement plus saline dressings alone and total off loading. So if you're thinking that your patient is a candidate for Apligraf some things to consider: you want to try and make the wound bed as ready for the Apligraf as possible, you want to be environmentally friendly to the Apligraf. If the wound needs to be debrided it should be done one week prior to application and not the day of the application to avoid the Apligraf floating off. You may also want to consider using an antimicrobial such as the Silver dressing to try to really prepare the wound bed to make it as clean as possible before applying the Apligraf to give it the best chance of taking.

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What happens after the Apligraf is applied to your diabetic foot wound? Well, the Apligraf covers and protects the wound. In fact, some patients that weren’t neuropathic said that they did have pain relief when the Apligraf was placed. It contains a combination of cytokines and growth factors found in human skin. Like human skin, Apligraf consists of living skin cells and structural proteins. But unlike human skin, Apligraf does not contain melanocytes, Langerhan’s cells, macrophages, and lymphocytes, or other structures such as blood vessels, hair follicles, or sweat glands.

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Here what I’ve done is I’ve basically just given you Apligraf verses human skin, side by side. Besides the obvious differences of the hair follicles and the sweat glands you can see that the Apligraf and the human skin have many of the same characteristics.

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Now I’d like to talk about off loading. Off loading as everybody knows is paramount in the care of the diabetic foot ulcer. Lack of sensation prevents the patient from realizing trauma being inflicted on the wound. Off loading these areas prevents constant micro-trauma, thus enabling the wound to heal. There're several different ways to offload the wound. If the patient is mobile, various shoes can assist in offloading. If the patient is confined to the bed, there are several different mattresses and devices to offload pressure evenly that are available.

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Let’s talk for a minute about how footwear is related to offloading. There are various types of footwear for offloading the affected area of the foot. Care must be taken to ensure that a new area of friction is not being created in the new footwear. Patients must be educated to perform daily foot infections to watch for these hotspots.

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Now I'd like to talk about nutritional support. Nutritional assessment should be performed on every “at risk” patients or those with existing wounds. You should really look at their pre-albumin versus their albumin as it's a better indication for malnutrition and so you would know where to go with wound healing and nutrition. The body must be in a positive nitrogen balance and order for a wound to heal. Calories, nutrients, protein, and fluid are all very important. You'd want to seek a consult from a registered dietitian for a more comprehensive picture.

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Now I'd like to talk about negative pressure wound therapy. In negative pressure wound therapy, negative pressure or suction is applied with a tube and sealed with an occlusive dressing over the wound. “Stretches” cells involved the wound healing process, which releases biochemical mediators of cell proliferation and pulls them together; thus healing the wound. The vacuum effect evacuates wound fluid, reduces edema, and helps form new blood vessels and granulation tissue. This can be useful for large deficits as the also can be useful for multiple deficits as it can be bridged together.

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Ultrasonic Debridement has been found to be effective, safe removal of necrotic, devitalized or infected tissue, fibrin and foreign materials. There’s minimal to no bleeding and it’s virtually pain free to the patient. After ultrasonic debridement, exceptional granulation tissue is seen.

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Surgical repair can also be thought of as an adjunctive treatment. Some surgical repairs include: free tissue transfer flap, myofasciocutaneous flap or rotation flap; random flap, split and full thickness skin grafts; primary and secondary approximation. These are done to hasten healing or to save a limb or life.

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Hydrotherapy: Hydrotherapy is the application of water or cleansing fluid to the wound bed for debridement of less than 50% necrotic tissue to the wound bed. Ways of delivering hydrotherapy: whirlpool. But whirlpool is somewhat an antiquated measure with infection control issues. Pulse lavages used in stage 3 and 4 pressure ulcers. It’s not recommended for venous ulcers. Hydrotherapy should be discontinued when the wound bed is finally clean.

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As I come to the end of my lecture on Adjunctive Therapies you can see that the use of these different types of adjunctive therapies along with aggressive wound care may make the difference between limb salvage and limb amputation.

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I’d like to thank you for your time today and I hope I’ve shed some light on adjunctive therapies to be used in the care of the diabetic foot. Thank You!