An estimated 1.2 million people with diabetes suffer from lower extremity ulcers each year, and of all the foot amputations in the United States, 84 percent, or 60,000 amputations, are related to diabetic foot ulcers.
The real tragedy in these numbers is that most amputations are preventable.
While these ulcers are psychologically, physically and financially draining to those who must deal with them, there is still reason for hope with prevention techniques and the boom of innovative products and services offered to treat them today.
When someone has an ulcer, the goal is to prevent it from developing into a problem which requires amputation. Therefore, the goal of this article is to create understanding of ulcers and offer a survey of some of the products which can help from resorting to amputation. (See below for some of the wound care product and service options.)
Ulcers can develop for a variety of reasons. In fact, it’s a misconception to think that someone has to have a physical cut in the skin for an ulcer to develop.
“People don’t have to injure their foot at all,” says Ron Scott, MD, of the Curative Wound Care Center at the Presbyterian Hospital in Dallas. Diabetics often have abnormal areas of calluses, corns or other foot deformations which, when in a constant state of friction, can cause internal hemorrhaging explains Scott. Callus formation and tingling sensations may be the first signs of these changes.
Any injured or infected area on the foot can develop an ulcer if not cared for properly. Layers of skin and foot tissue are gradually destroyed by infection, creating a hole. The hole may grow as deep as the bone and even infect the bone as well. This can all happen surprisingly quickly.
If an infection goes out of control, a surgeon may need to remove a part of the foot, or even the entire foot and leg, in order to prevent the infection from spreading and to save a person’s life.
Two diabetes-related problems directly contribute to the danger of foot ulcers: nerve damage and poor circulation. Diabetics often suffer from neuropathy which can manifest itself in reduced sensation in the extremities. Because of this nerve damage, people with diabetes may not feel minor sores and their development into ulcers.
Once a sore has developed, the healing process can be worsened by poor circulation. For a wound to heal properly, it needs fresh blood constantly circulated to the site. Peripheral vascular disease which causes decreased circulation is two-and-a-half to three times more common in persons with diabetes.
The emotional toll of these amputations is overwhelming, but it is not the only psychological aspect of the problem. After years of working with diabetic foot ulcers, Ron Scott is amazed by the complex relationship between psychological issues and foot ulcers. While people with diabetes often can’t feel the injuries, he wonders how someone can live with unsightly and often odorous wounds for such long periods of time.
“Many times it seems like patients somehow psychologically divorce themselves from that part of the body,” Scott says.
This “divorce” can lead to a neglecting of the wound, causing it to worsen and spread into surrounding areas. Constant maintenance is imperative for proper healing to occur.
Treatment: The Environment For Proper Healing
For a wound to heal properly, it must be kept clean. Dead tissue must be removed from a wound site continually to prevent the spreading of infection to surrounding skin, a process known as cell debridement. In addition, skin around a wound must be kept moisturized and in good shape.
“This is a major concern in wound care therapy and preventing amputation,” Ed Coghlin, spokesperson from wound care manufacturer MedLogic Global Corporation says. “The area around the wound must be kept intact to prevent spreading of sores and infection.”
If the wound is a naturally wet wound, then products must be used to absorb the discharge. On the other hand, if it is a dry wound then a moisturizing product should be used.
Also, deeper wounds will require more care. “It’s important to eliminate the ‘dead space,’ absorb discharge and maintain a moist wound surface for wounds that go deep,” says Mary Antensteiner from the wound care product manufacturer, PolyMem.
Treatment: Thinking Globally
The market for wound care products has boomed recently, but people often make the mistake of exclusively treating wounds and ulcers locally rather than looking at the big picture.
“People think they can only treat the wound itself,” says Robin Carmichael, RN, BSN from the wound care product company, Procyte. “But really you must tackle the underlying disorders which cause this ulcer,” she says.
The first and most important step is maintaining good BG control. This will improve circulation and increase the body’s natural capacity to heal. The more glucose there is in the blood, the harder it is for it to circulate freely. In severe cases, bypass surgery in the extremities may even be necessary to get sufficient blood flow to the lower legs and feet.
In addition to good BG control, proper nutrition is key to proper wound care therapy. “Persons with foot ulcers should definitely follow a nutritious diet,” advises Stephen H. Freed, RPh, CDE. “The body does great things when its getting the proper amounts of proteins, carbohydrates and fats.”
Freed emphasizes that good nutrition is an integral part of treating wounds and ulcers, even when wound care products are being used. “I had a patient who tried many products for healing an ulcer and was unsuccessful in his attempts. But when he combined the wound care products with eating right, his ulcer cleared up in six weeks. He was amazed when hair even started growing back on his toes,” says Freed.
Freed notes that when obtaining three nutritious meals a day in not possible, it is wise to take nutritional supplements. While the ADA, NIH and other organizations offer guidelines for a correct diet, alterations may be needed according to individual needs.
Treatment: Thinking Locally
Many different topical agents are on the market and each offers something a little different from the others.
So, how does one choose the proper medication?
“There are several factors to consider when choosing a wound care product. It should be a combination of what your needs are, your budget, and what will be convenient for you to use,” says Freed. “Every wound is different, so the healing agents needed will vary and only you and your health care professional can make the correct decisions.”
Many people try to self-treat wounds with these topical agents. However, a medical professional should definitely be consulted on proper routes for treatment. Professionals can provide patients with access to the treatments that will work best for them. While some wound care products are offered over the counter, the majority are only available by prescription.
“One thing that people have to remember,” Scott says, “is that even with the best treatments, you have to stay off of your feet while treating lower extremity ulcers. When your doctor says ‘stay off your feet,’ even two steps is two steps too many.”
Daring to be Different: Alternative Wound Care Therapies
The thought of maggots and leeches makes most people’s skin crawl. But as it turns out, these reviled little creatures can help diabetic patients clear up stubborn wounds and ulcers.
“These treatments certainly have their merit, but convincing the nurses, much less the patients, to work around maggots and leeches is quite a chore,” Scott says. “I remember once when a dozen of the leeches got loose in the hospital refrigerator – not a pleasant situation.”
Maggot therapy consists of mixing live fly larvae into a wound’s dressing and covering it with gauze. Maggots feast on the dead tissue and leave the healthy tissue behind. They also secrete an ammonia-like, anti-microbial chemical which helps cleanse the wound. When the dressing is cut away two or three days later, the engorged maggots are now up to 10 times their original size and are easily removed.
Doctors use leeches by attaching them to the open wound and acting as an anesthetic and anticoagulant. They also work to take up excess blood at the wound site.
Another therapy being used in Canada, the United Kingdom and currently under FDA review in the United States, seems that it would be potentially even more controversial than leech and maggot therapy. It consists of using skin cells from the foreskins of circumcised infants and placing them into a bio-reactor to generate dermal skin layers. Doctors place these skin layers on a wound to act as a surrogate layer of skin which speeds healing at the wound site.
In the end, many new treatments and products are being offered to prevent an amputation. While having one of these wounds is extremely taxing on someone, he or she should remember that hope shouldn’t be lost and innovative help is increasingly becoming available.
The following is a compilation of several of the products on the market for treating diabetic ulcers. Product information and descriptions come from the manufacturers and providers of these products and services and do not necessarily reflect the views of this paper.
Advanced Tissue Sciences innovative therapy distributed by Smith & Nephew
This new technological process places artificially grown dermal skin on a wound to instigate healing. After parental consent, skin cells from the foreskins of circumcised newborns are placed in a bio-reactor and grown into the dermal skin layer. This therapy is on the market in Canada, the United Kingdom and is currently awaiting FDA approval in the United States. They also anticipate launching the product into other European countries.
For more information, call (619) 450-5793.
ArtAssist the arterial assist device by ACI Medical
Wound healing is often slower and more difficult in people with diabetes because of poor circulation in the extremities. The ArtAssist is a non surgical, non pharmaceutical and non invasive treatment option that increases blood flow below the knee 2.5 to three times. The device provides intermittent pressure to the lower leg and foot, a procedure that has been shown to improve arterial blood flow in clinical trials.
The ArtAssist provides pneumatic pressure via cuffs housed in a lower-leg cast and sandal-like shoe. Therapy takes place with the user in a comfortable sitting position. All the user needs to do is turn the device on and sit down – all timing and pressure controls are built in. The device must be prescribed by physician and can be rented from ACI.
For more information call (800) 667-9451 or visit ACI’s website at www.acimedical.com.
Biafine Wound Dressing Emulsion (WDE) from Medix
Biafine WDE is a fluid, but firm, emulsion that conforms to the contours of wounds. It is water soluble and can be washed away without damaging sensitive newly formed tissue in the wound site. During treatment, it cleanses and absorbs wound discharge, removes dead cells and tissue debris and maintains a moist healing environment. It also contains a nontoxic, herbal based fragrance that removes the unpleasant odor sometimes associated with wound discharge.
Its make-up allows dead tissue to enter the emulsion rather than forming a harmful layer between the wound and the newly forming tissue. It can be used for diabetic ulcers, burns (except third degree) and radiodermatitis.
For more information call (888) BIAFINE (242-3463).
Curative Wound Care Centers
Curative manages more than 170 outpatient wound care centers in hospitals across the United States and Puerto Rico. Curative offers a technically advanced treatment program which it claims consistently yields better clinical outcomes at lower costs than traditional treatment approaches.
Curative has also developed the Procuren growth factor therapy, which is only used at the Curative Wound Care Centers. The therapy consists of obtaining blood platelets from the patient’s own blood and making a medication to be placed topically on the wound. The medication stimulates growth at the sore site. While Curative only uses Procuren with 20 to 25 percent of their patients, diabetics often receive this treatment since it works well on persons with neuropathy or circulation problems.
Call (800) 579-5959 to find the center nearest you.
Cutinova wound dressings from Biersdorf/Jobst, Inc.
A moist wound environment tends to heal faster and reduce the chances of infection. Cutinova dressings are made from polyurethane, a highly absorbent material that helps create a clean moist environment that promotes healing, conforms to individually fit every wound and does not stick to wounds. Cutinova offers several dressings designed to provide a moist healing environment for different types of wounds at every stage of severity.
For more information call (800) 537-1063.
Cytolex topical antibiotic cream by Magainin Pharmaceuticals Inc.
Cytolex is a magainin peptide, part of the first new class of antibiotics to be introduced in 17 years. Cytolex has completed clinical trials, and it has been submitted for FDA approval. It will be the first antibiotic specifically labeled for the treatment of infection in a diabetic foot if cleared by the FDA. Because of its unique biochemical mechanism of action, Cytolex provides a significant reduction in the risk of antibiotic resistance, a complication that can arise when patients are exposed to systemic antibiotics for long periods. If approved, the company hopes to have the product out by early 1999.
The DiaB Line by Carrington Laboratories
Carrington makes DiaB Nutri, a dietary supplement in tablet form; DiaB Klenz, a spray wound cleaner for the removal of dead tissue from diabetic foot and leg ulcers; DiaB Gel, a wound care preparation for the management of diabetic ulcers; and DiaB Cream, a post-healing moisturizing cream that smooths and softens dry skin and calluses.
DiaB Gel, Cream and Nutri all make use of Acemannan, Carrington’s stabilized, pharmaceutically produced aloe vera extract that has the same favorable effects on burns and wounds as fresh aloe vera leaves. The gel and cream also keep wound sites moist to promote healing.
For more information call Caraloe Inc., Carrington’s consumer division at (800) 444-ALOE (2563), or visit its website at www.aloevera.com.
Iamin Hydrating Gel by the ProCyte Corporation
Contains patented copper peptide ingredient which gives the product its unique blue color. The technology has been shown, at the cellular level, to play a key role in vital wound repair processes. It enhances the natural, moist healing environment and enhances essential micronutrition.
For more information, call (800) 848-3668
Multidex powder/gel wound dressing by De
Multidex wound dressings are available in gel (for dry wounds) and powder (for moist wounds) form. The dressings are nontoxic, control odor, completely fill in wound holes, and are not absorbed into the body. They can be used for all chronic, acute and burn wounds (except third degree burns). Both dressings create and maintain a moist environment that is beneficial for tissue growth.
DeRoyal Consumer Products, a division of DeRoyal Industries, Inc., provides Multidex wound care packets that contain all the supplies needed to treat wounds at home for seven days. Packets are available for wounds under 1 1/2 inches and wounds 1 1/2 to 2 1/2 inches in diameter.
For more information call (800) 251-9864.
Optiscan-2000 a foot periscope from Optiscan Ltd.
The Optiscan consists of an eyepiece connected to an illuminated wand by a fiber optic cable. The wand is designed to pass along the contours of the foot and magnify areas to twice their size. This allows patients to check for abnormalities in hard to reach areas on the top and bottom of feet without the assistance of others. A measurement grid in the eyepiece allows users to precisely track the appearance and growth of any abnormalities and report them objectively to their doctors.
For more information call (800) 801-5600.
PolyMem “pink” dressing by Ferris
PolyMem dressing works to disinfect, moisturize and loosen dead tissue at wound sites. Because it disinfects wound sites, dressing and bandage changes are not needed as frequently thereby lessening the chances of disturbing growing tissue. The PolyMem bandage is thin enough to allow the wound to “breath” and is transparent. As a result, one can see when a bandage needs to be changed without having to disrupt the dressing and aggravate delicate healing tissue. In addition, Ferris claims that bandage removal is significantly less uncomfortable because of PolyMem’s moisturizers.
Ferris also manufactures PolyWic, a dressing for packing deep cavity wounds.
For more information call (800) POLYMEM (765-9636)
Regranex Gel sold by Johnson & Johnson subsidiary Chiron
Regranex is a topical gel which is currently waiting for FDA approval. According to Chiron, the gel significantly increased the rate of complete healing by 43 percent in clinical trials. The active ingredient is a genetically engineered platelet-derived growth factor, a naturally occurring protein in the body that stimulates diabetic ulcer healing.
For more information, call (800) 596-9341
Superskin liquid film dressing by MedLogic Corp.
It protects the intact skin around the edges of all types of wounds and prevents tears and wound from spreading. It stays on the skin for 24 to 36 hours. The liquid film dressing forms an impermeable bond and prevents the skin around wound from becoming too moist and consequently from being destroyed.
For more information, call (800) 625-6442
TheraSock double sock system by TheraFoot Technologies
TheraSock’s sock-within-a-sock design provides a buffered sock system which reduces the “skin shear” that leads to blisters, corns, calluses and other skin injuries. According to TheraFoot, TheraSocks provide superior comfort, support and pressure relief.
For more information call (888) 466-0001.