Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers. This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
The first patient has been dosed in a Phase III trial assessing ViroMed’s VM202, the first pivotal study of a gene therapy indicated for patients with nonhealing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD).
The Phase III trial (NCT02563522) is a double-blind, placebo-controlled, multicenter study designed to evaluate VM202 for safety and efficacy in 300 adults with a diabetic foot ulcer and concomitant PAD. Two hundred patients will be randomized to VM202 and the other 100 to placebo, ViroMed’s U.S. division VM BioPharma said yesterday. (more…)
When Dr. Breanne Everett began training to become a plastic surgeon she was shocked by the number of foot problems, including amputations, she was seeing among diabetic patients. She decided to look for a solution.
That led the 32-year-old physician to put her medical training on hold and make the transition into business and technology.
She invented a device to alert diabetic patients before a sore spot on their foot turned into a wound that could cause severe complications.
The Calgary company she founded — Orpyx — developed pressure-sensitive insole technology to feed information to patients and prevent the kinds of wounds that can lead to amputations in diabetics with peripheral neuropathy, which can cause numbness in the feet.
The company’s smart-sole foot protection system is attracting attention around the world with ongoing clinical trials in both the U.S. and U.K. The product is available through the company, which calls it the only device of its type on the market.
Electrical stimulation and pressure ulcer healing in SCI patients A systematic review of eight clinical trials of 517 patients with spinal cord injury (SCI) and at least one pressure ulcer indicates that electrical stimulation increases the healing rate of pressure ulcers. Wounds with electrodes overlaying the wound bed seem to have faster pressureulcer healing than wounds with electrodes placed on intact skin around the ulcer.
As a wound care specialist, you have learned about many skin conditions, some so unusual and rare that you probably thought you would never observe them. I’ve been a nurse for 38 years, with the last 10 years in wound care, and that’s certainly what I thought. But I was wrong. Let me tell you about my challenging patient with…
As full-thickness wounds heal, they begin to fill in from the bottom upward with granulation tissue. At the same time, wound edges contract and pull together, with movement of epithelial tissue toward the center of the wound (contraction). These epithelial cells, arising from either the wound margins or residual dermal epithelial appendages within the wound bed, begin to migrate in leapfrog or train fashion across the wound bed. Horizontal movement stops when…
Electrical stimulation and pressure ulcer healing in SCI patients A systematic review of eight clinical trials of 517 patients with spinal cord injury (SCI) and at least one pressure ulcer indicates that electrical stimulation increases the healing rate of pressure ulcers. Wounds with electrodes overlaying the wound bed seem to have faster pressureulcer healing than wounds with electrodes placed on intact skin around the ulcer.
Here is a round-up of resources that you may find helpful in your practice. New illustrations for pressure-injury staging The National Pressure Ulcer Advisory Panel (NPUAP) has released new illustrations of pressure injury stages. You can download the illustrations, which include normal Caucasian and non-Caucasian skin illustrations for reference. There is no charge for the illustrations as long as they are being used for educational purposes, but donations to…
By Nancy Morgan, RN, BSN, MBA, WOC, WCC, DWC, OMS Each issue, Apple Bites brings you a tool you can apply in your daily practice. Here’s an overview of cutaneous candidiasis. Cutaneous candidiasis is an infection of the skin caused by the yeast Candida albicans or other Candida species. Here’s a snapshot of this condition.
Topical application of silver nitrate is often used in wound care to help remove and debride hypergranulation tissue or calloused rolled edges in wounds or ulcerations. It’s also an effective agent to cauterize bleeding in wounds. Silver nitrate is a highly caustic material, so it must be used with caution to prevent damage to healthy tissues.
For an ostomy pouching system to adhere properly, the skin around the stoma must be dry and intact. Otherwise, peristomal skin problems and skin breakdown around the stoma may occur. In fact, these problems are the most common complications of surgical stomas. They can worsen the patient’s pain and discomfort, diminish quality of life, delay rehabilitation, increase use of ostomy supplies, and raise healthcare costs. Peristomal skin problems also perpetuate a…
By Jeri Lundgren, BSN, RN, PHN, CWS, CWCN Many factors can contribute to the formation of a pressure ulcer, but it’s rare that one develops in an active, mobile patient. As the National Pressure Ulcer Advisory Panel 2014 guidelines state, “Pressure ulcers cannot form without loading, or pressure on the tissue. Extended periods of lying or sitting on a particular…
Imagine watching your skin tear, bleed, and turn purple. Imagine, too, the pain and disfigurement you’d feel. What if you had to live through this experience repeatedly? That’s what many elderly people go through, suffering with skin tears through no fault of their own. Some go on to develop complications. A skin tear is a traumatic wound caused by shear, friction, or blunt-force trauma that results in a partial-…
This issue marks the fourth anniversary of the “Best of the Best” issue of Wound Care Advisor, the official journal of the National Alliance of Wound Care and Ostomy. Fittingly, it comes during an Olympics year. Since 1904, the Olympics have awarded gold medals to athletes whose performance makes them the “best of the best.” This year, we’re proud to present our own “Best…
By Roxana Reyna, BSN, RNC-NIC, WCC, CWOCN As wound care clinicians, we are trained—and expected—to help heal wounds in patients of any age and to achieve positive outcomes. Basic wound-healing principles apply to all patients, whatever their age or size. The specific anatomy and physiology of vulnerable pediatric patients, however, requires detailed wound care. Unfortunately, little evidence-based research exists to…
Diabetic foot ulcers stem from multiple factors, including peripheral neuropathy, high plantar pressures, decreased vascularity, and impaired wound healing. Contributing significantly to morbidity, they may cause limb loss and death. (See Foot ulcers and diabetes.) Initially, hydrocolloid dressings were developed to function as part of the stomal flange. Based on their success in protecting peristomal skin, they were introduced gradually…
At the 2015 Wild on Wounds conference, the interactive workshop “Are You Ready for an Outpatient Reimbursement Challenge?” featured a lively discussion among participants about 25 real-life reimbursement scenarios. Here are the top 10 questions the attendees asked, with the answers I provided.
Q Why is it necessary for qualified healthcare professionals (QHPs) such as physicians, podiatrists, nurse practitioners, physician assistants, and clinical nurse specialists to identify the place of service where they provide wound care services and to correctly state the place of service on their claim forms?
We all lead busy lives, with demanding work schedules and home responsibilities that can thwart our best intentions. Although we know it’s our responsibility to stay abreast of changes in our field, we may feel overwhelmed when we try to make that happen. Keeping clinicians up-to-date on clinical knowledge is one of the main goals of the Wild On Wounds…
As a wound care specialist, you have learned about many skin conditions, some so unusual and rare that you probably thought you would never observe them. I’ve been a nurse for 38 years, with the last 10 years in wound care, and that’s certainly what I thought. But I was wrong. Let me tell you about my challenging patient with…
Value of systematic reviews and meta-analyses in wound care “Systematic reviews and meta-analyses—literature-based recommendations for evaluating strengths, weaknesses, and clinical value,” in Ostomy Wound Management, discusses evidence-based practice and how systematic reviews (SRs) and meta-analyses (MAs) can help improve management of wound care patients. The authors of the article explain evidence-based practice and provide useful definitions for key terms. They…
Start the New Year off right by checking out these resources. Pressure ulcer prevention education Access the following education resources from Wounds International: The webinar “Real-world solutions for pressure ulcer prevention: Optimising the role of support surfaces” includes: • an overview of the issue of pressure ulcers • what to consider when choosing a support surface • how to operationalize…
A fundamental rule of wound care is to treat the “whole” patient, not just the “hole” in the patient. To do this, we need to focus on a holistic approach to healing, which means evaluating everything that’s going on with the patient—from nutrition, underlying diseases, and medications to activity level, social interactions, and even sleep patterns. We know that as…
Developing a pressure ulcer can cause the patient pain, lead to social isolation, result in reduced mobility, and can even be fatal. According to the Agency for Healthcare Research and Quality, estimated costs for each pressure ulcer range from $37,800 to $70,000, and the total annual cost of pressure ulcers in the United States is an estimated $11 billion. Nurses…
Each issue, Apple Bites brings you a tool you can apply in your daily practice. Here are examples of medications that can affect wound healing. Assessment and care planning for wound healing should include a thorough review of the individual’s current medications to identify those that may affect healing outcomes. Clinicians must then weigh the risks and benefits of continuing…
Diabetic foot ulcers stem from multiple factors, including peripheral neuropathy, high plantar pressures, decreased vascularity, and impaired wound healing. Contributing significantly to morbidity, they may cause limb loss and death. (See Foot ulcers and diabetes.) Initially, hydrocolloid dressings were developed to function as part of the stomal flange. Based on their success in protecting peristomal skin, they were introduced gradually…
Immobility affects all our body systems, including our skin. According to the National Pressure Ulcer Advisory Panel, many contributing factors are associated with the formation of a pressure ulcer, with impaired mobility leading the list. So what can clinicians do to prevent harm caused by immobility? One often-overlooked strategy is a restorative nursing program. (See About restorative nursing.) Moving up…
Being positive in a negative situation is not naïve. It’s leadership. — Ralph S. Marston, Jr., author and publisher of The Daily Motivator website Clinicians may encounter many challenges and stressors in the workplace—long hours, rotating shifts, inadequate staffing, poor teamwork, and pressure to achieve higher performance levels in an emotionally and physically demanding field. But hope exists. Positive psychology…
At the 2015 Wild on Wounds conference, the interactive workshop “Are You Ready for an Outpatient Reimbursement Challenge?” featured a lively discussion among participants about 25 real-life reimbursement scenarios. Here are the top 10 questions the attendees asked, with the answers I provided. Q Why is it necessary for qualified healthcare professionals (QHPs) such as physicians, podiatrists, nurse practitioners,…
Keeping clinicians up-to-date on clinical knowledge is one of the main goals of the Wild on Wounds (WOW) conference held each September in Las Vegas. Every year, I present the opening session, called “The Buzz Report,” which focuses on the latest-breaking wound care news—what’s new, what’s now, and what’s coming up. I discuss new products, practice guidelines, resources, and tools from the last 12 months in skin, wound, and ostomy management.
In the January issue, I discussed some of the updates from my 2015 Buzz Report. Now I’d like to share a few more, along with some of my favorite resources. (more…)
Diabetic foot ulcers stem from multiple factors, including peripheral neuropathy, high plantar pressures, decreased vascularity, and impaired wound healing. Contributing significantly to morbidity, they may cause limb loss and death. (See Foot ulcers and diabetes.)
Initially, hydrocolloid dressings were developed to function as part of the stomal flange. Based on their success in protecting peristomal skin, they were introduced gradually into other areas of wound care. They contain wafers of gel-forming polymers, such as gelatin, pectin, and cellulose agents, within a flexible water-resistant outer layer. The wafers absorb wound exudate, forming a gel and creating a moist healing environment. (more…)
Be sure you’re familiar with these valuable resources for you and your patients.
Colorectal cancer resources
Fight Colorectal Cancer has a comprehensive resource library for patients, including:
a link to “My Colon Cancer Coach,” which provides a personalized report to help guide patients in making treatment decisions
archives of webinars (past topics include healthy changes that may reduce recurrence, highlights from a GI cancer symposium, and making sense of acronyms)
a link to the National Comprehensive Cancer Network guidelines for patients
videos on colon cancer signs and symptoms, peripheral neuropathy, and a patient answer line
a family history worksheet
a newly diagnosed information card and a screening information card that can be downloaded
To begin appropriate treatment for chronic venous insufficiency (CVI), clinicians must be able to make the correct diagnosis. Part 1 (published in the March-April edition) described CVI and its presentation. This article provides details of the CVI diagnosis (including the differential diagnosis from other diseases), disease classification to help assess the extent of CVI, diagnostic studies used to diagnose CVI, and various treatment options to “rescue” the patient from CVI. (more…)
Each month, Apple Bites brings you a tool you can apply in your daily practice.
Description
According to the American Diabetes Association, all patients with diabetes should be screened for loss of protective sensation in their feet (peripheral neuropathy) when they are diagnosed and at least annually thereafter, using simple clinical tests such as the Semmes-Weinstein monofilament exam.
The Semmes-Weinstein 5.07 monofilament nylon wire exerts 10 g of force when bowed into a C shape against the skin for 1 second. Patients who can’t reliably detect application of the 5.07, 10-g monofilament to designated sites on the plantar surface of their feet are considered to have lost protective sensation. (more…)
Guidelines for managing prosthetic joint infections released
The Infectious Diseases Society of America has released guidelines for diagnosing and managing prosthetic joint infections.
“Diagnosis and management of prosthetic joint infection: Clinical practice guidelines by the Infectious Diseases Society of America,” published in Clinical Infectious Diseases, notes that of the 1 million people each year who have their hips or knees replaced, as many as 20,000 will get an infection in the new joint.
The guidelines describe the best methods for diagnosing these infections, which are not easy to identify. Specifically, infection should be suspected in a patient who has any of the following: persistent wound drainage in the skin over the joint replacement, sudden onset of a painful prosthesis, or ongoing pain after the prosthesis has been implanted, especially if there had been no pain for several years or if there is a history of prior wound healing problems or infections.
Guidelines for treating infections are included and note that 4 to 6 weeks of I.V. or highly bioavailable oral antibiotic therapy is almost always necessary to treat prosthetic joint infections.
A decade of TIME
The TIME acronym (tissue, infection/inflammation, moisture balance, and edge of wound) was first developed more than 10 years ago to provide a framework for a structured approach to wound bed preparation and a basis for optimizing the management of open chronic wounds healing by secondary intention. To mark the event, the International Wound Journal has published “Extending the TIME concept: What have we learned in the past 10 years?”
The review points out four key developments:
• recognition of the importance of biofilms (and the need for a simple diagnostic)
• use of negative-pressure wound therapy
• evolution of topical antiseptic therapy as dressings and for wound lavage (notably, silver and polyhexamethylene biguanide)
• expanded insight into the role of molecular biological processes in chronic wounds (with emerging diagnostics).
The authors conclude, “The TIME principle remains relevant 10 years on, with continuing important developments that incorporate new evidence for wound care.”
Bed alarms fail to reduce patient falls
A study in Annals of Internal Medicine found that the use of bed alarms had no statistical or clinical effect on falls in an urban community hospital.
The 18-month trial included 16 nursing units and 27,672 inpatients. There was no difference in fall rates per 1,000 patient-days, the number of patients who fell, or the number of patients physically restrained on units using bed alarms, compared with control units.
Authors of “Effects of an intervention to increase bed alarm use to prevent falls in hospitalized patients: A cluster randomized trial” speculate the lack of response may be related to “alarm fatigue.”
Drug for HIV might help in Staph infections
A study in Nature reports that the drug maraviroc, used to treat HIV, might be useful for treating Staphylococcus aureus infections.
“CCR5 is a receptor for Staphylococcus aureus leukotoxin ED” found that the CCR5 receptor, which dots the surface of immune T cells, macrophages, and dendritic cells, is critical to the ability of certain strains of Staph to specifically target and kill cells with CCR5, which orchestrate an immune response against the bacteria. One of the toxins the bacterium releases, called LukED, latches on to CCR5 and subsequently punches holes through the membrane of immune cells, causing them to rapidly die.
When researchers treated cells with CCR5 with maraviroc and exposed the cells to the Staph toxin, they found maraviroc blocked toxic effects.
Dog able to sniff out C. difficile
A 2-year-old beagle trained to identify the smell of Clostridium difficile was 100% successful in identifying the bacteria in stool samples, and correctly identified 25 of 30 cases of patients with C. difficile, according to a study in BMJ.
“Using a dog’s superior olfactory sensitivity to identify Clostridium difficile in stools and patients: Proof of principle study” discusses how the dog was trained to detect C. difficile and concludes that although more research is needed, dogs have the potential for screening for C. difficile infection.
After-hours access to providers reduces ED use
Patients who have access to their primary healthcare providers after hours use emergency departments (EDs) less frequently, according to a study in Health Affairs.
“After-hours access to primary care practices linked with lower emergency department use and less unmet medical need” found that 30.4% of patients with after-hours access to their primary care providers reported ED use, compared with 37.7% of those without this access. In addition, those with after-hours access had lower rates of unmet needs (6.1% compared to 12.7%).
The findings come from the 2010 Health Tracking Household Survey of the Center for Studying Health System Change. The total sample included 9,577 respondents.
Neuropathic pain in patients with DPN might contribute to risk of falling
The presence of neuropathic pain in patients with diabetic peripheral neuropathy (DPN) contributes to gait variability, which could in turn contribute to the risk of falling, according to “Increased gait variability in diabetes mellitus patients with neuropathic pain.”
The study, published in the Journal of Diabetes and Its Complications, compared patients with at least moderate neuropathic pain with those who had no pain. Researchers used a portable device to measure gait parameters, such as step length and step velocity.
Amputation rates decrease significantly in patients with PAD
“Temporal trends and geographic variation of lower-extremity amputation in patients with peripheral artery disease (PAD): Results from U.S. Medicare 2000–2008” found that amputation rates have decreased significantly, but that significant patient and geographic variations remain.
The study, published in the Journal of the American College of Cardiology, found that among 2,730,742 older patients with identified PAD, the overall rate of lower extremity amputation decreased from 7,258 per 100,000 patients to 5,790 per 100,000. Predictors of lower-extremity amputation included male sex, black race, diabetes mellitus, and renal disease.
By Carrie Carls, BSN, RN, CWOCN, CHRN; Michael Molyneaux, MD; and William Ryan, CHT
Every year, 1.9% of patients with diabetes develop foot ulcers. Of those, 15% to 20% undergo an amputation within 5 years of ulcer onset. During their lifetimes, an estimated 25% of diabetic patients develop a foot ulcer. This article discusses use of hyperbaric oxygen therapy (HBOT) in treating diabetic foot ulcers, presenting several case studies.
HBOT involves intermittent administration of 100% oxygen inhaled at a pressure greater than sea level. It may be given in a:
• multi-place chamber (used to treat multiple patients at the same time), compressed to depth by air as the patient breathes 100% oxygen through a face mask or hood (more…)
New wound-swabbing technique detects more bacteria
The new Essen Rotary swabbing technique takes a few seconds longer to perform than traditional techniques, but improves bacterial count accuracy in patients with chronic leg ulcers, according to a study published by Wounds International.
“Evaluation of the Essen Rotary as a new technique for bacterial swabs: Results of a prospective controlled clinical investigation in 50 patients with chronic leg ulcers” reports that Essen Rotary detected significantly more bacteria compared to standard techniques and was the only one to identify five patients with methicillin-resistant Staphylococcus aureus (MRSA), compared to three detected by other techniques.
The Essen Rotary technique samples a larger surface area of the wound, which is beneficial for detecting MRSA.
“The Essen Rotary may become the new gold standard in routinely taken bacteriological swabs especially for MRSA screenings in patients with chronic leg ulcers,” the study authors write.
Reducing HbA1c by less than 1% cuts cardiovascular risk by 45% in patients with type 2 diabetes
A study presented at the American Diabetes Association 72nd Scientific Sessions found lowering HbA1c an average of 0.8% (from a mean of 7.8% to 7.0%, the treatment target) reduced the risk of cardiovascular death by 45% in patients with type
2 diabetes.
The absolute risk of mortality from a cardiovascular event was 9.9 events per 1,000 person-years in patients with decreasing HbA1c compared to 17.8 events in patients with stable or increasing HbA1c.
“HbA1c reduction and risk of cardiovascular diseases in type 2 diabetes: An observational study from the Swedish NDR” examined data from 18,035 patients in the Swedish National Diabetes Register.
CMS revises hospital, nursing home comparison websites
The Centers for Medicare & Medicaid Services (CMS) has enhanced two websites designed to help the public make informed choices about their health care. Hospital Compare and Nursing Home Compare now have better navigation and new comparison tools. The two sites include data on quality measures, such as frequency of hospital-acquired infections, and allow the user to compare hospitals on these measures.
Improvements include easy-to-use maps for locating hospitals, a new search function that enables the user to input the name of a hospital, and glossaries that are easier to understand. It’s now also possible to access the data on the sites through mobile applications.
CMS maintains the websites, which are helpful for anyone who wants to compare facilities, not just patients on Medicare or Medicaid.
For more information, read the article in Healthcare IT News.
IOM releases report on accelerating new drug and diagnostics development
The Institute of Medicine (IOM) released “Accelerating the development of new drugs and diagnostics: Maximizing the impact of the Cures Acceleration Network—Workshop Summary.” The report is a summary of a forum that brought together members of federal government agencies, the private sector, academia, and advocacy groups to explore options and opportunities in the implementation of Cures Acceleration Network (CAN). The newly developed CAN has the potential to stimulate widespread changes in the National Institutes of Health and drug development in general.
Focus on individualized care—not just reducing swelling—in lymphedema patients
As a result of two extensive literature reviews, a researcher at the University of Missouri found that emphasizing quality of life—not just reducing swelling—is important for patients with lymphedema. Many providers and insurance companies base treatment on the degree of edema, but the volume of fluid doesn’t always correspond with the patients’ discomfort. Instead, an individualized plan of care should be developed.
The researchers found that Complete Decongestive Therapy (CDT), a comprehensive approach for treating lymphedema that includes skin and nail care, exercise, manual lymphatic drainage, and compression, may be the best form of specialized lymphedema management. For more information about CDT, watch for the November/December issue of Wound Care Advisor.
Plague case in Oregon draws national attention
An article about a case of the plague in Oregon has appeared on Huffington Post. A welder contracted the disease as a result of unsuccessfully removing a mouse from a stray cat’s mouth. Part of his hands have, in the words of the article, “darkened to the color of charcoal.” Later tests confirmed the cat had the plague.
Plague cases are rare in the United States. According to the Centers for Disease Control and Prevention, an average of 7 human cases are reported each year, with a range of 1 to 17 cases. Antibiotics have significantly reduced morality. About half of cases occur in people ages 12 to 45.
Use of negative pressure wound therapy with skin grafts
“Optimal use of negative pressure wound therapy for skin grafts,” published by International Wound Journal, reviews expert opinion and scientific evidence related to the use of negative pressure wound therapy with reticulated open-cell foam for securing split-thickness skin grafts.
The article covers wound preparation, treatment criteria and goals, economic value, and case studies. The authors conclude that the therapy has many benefits, but note that future studies are needed “to better measure the expanding treatment goals associated with graft care, including increased patient satisfaction, increased patience compliance and improved clinical outcomes.”
Mechanism for halting healing of venous ulcers identified
Researchers have identified that aberrantly expressed microRNAs inhibit healing of chronic venous ulcers, according to a study in The Journal of Biological Chemistry.
Six microRNAs were plentiful in 10 patients with chronic venous ulcers. The microRNAs target genes important in healing the ulcers. In an article about the study, one of the researchers said, “The more we know about the molecular mechanisms that contribute to [the development of venous ulcers], the more we can rationally develop both diagnostic tools and new therapies.”
Hemodialysis-related foot ulcers not limited to patients with diabetes
Both patients with diabetes and those without are at risk for hemodialysis-related foot ulcers, according to a study published by International Wound Journal.
Researchers assessed 57 patients for ulcer risk factors (peripheral neuropathy, peripheral arterial disease, and foot pathology, such as claw toes, hallux valgus, prominent metatarsal heads, corns, callosities, and nail pathologies) at baseline, and noted mortality 3 years later.
In all, 79% of patients had foot pathology at baseline, and 18% of patients without diabetes had peripheral neuropathy. Peripheral arterial disease was present in 45% of diabetic and 30% of nondiabetic patients. Nearly half (49%) of patients had two or more risk factors. Only 12% of patients had no risk factors. The presence of peripheral arterial disease and peripheral neuropathy increased risk of mortality.
The authors of “Prevalence of risk factors for foot ulceration in a general haemodialysis population” state that the high prevalence of risk factors in nondiabetic patients indicates that they are at risk for developing foot ulcers.
Study identifies risk factors for mortality from MRSA bacteremia
A study in Emerging Infectious Diseases found that older age, living in a nursing home, severe bacteremia, and organ impairment increase the risk of death from methicillin-resistant Staphylococcus aureus (MRSA) bacteremia.
Consultation with a specialist in infectious disease lowers the risk of death, and MRSA strain types weren’t associated with mortality.
“Predicting risk for death from MRSA bacteremia” studied 699 incidents of blood infection from 603 patients who had MRSA bacteremia.
