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…)
Carol Emanuele beat cancer. But for the last two years, the Philadelphia woman has been fighting her toughest battle yet. She has an open wound on the bottom of her foot that leaves her unable to walk and prone to deadly infection.
In an effort to treat her diabetic wound, doctors at a clinic in Northeast Philadelphia have prescribed a dizzying array of treatments. Freeze-dried placenta. Penis foreskin cells. High doses of pressurized oxygen. And those are just a few of the treatment options patients face.
“I do everything, but nothing seems to work,” said Emanuele, 59, who survived stage 4 melanoma in her 30s. “I beat cancer, but this is worse.” (more…)
Let us start off this post with a typical scenario. You walk into any facility or institution and you see a patient slouched in their wheelchair, with no wheelchair cushion. You notice part of their brief hanging out of the top of their pants, so you assume the patient may be incontinent. So let’s think about this for a minute. We most likely have friction, shear, and moisture going on with this patient.
This scenario is the perfect recipe for a pressure injury. So what can we do to help this patient and prevent a pressure injury from developing? We must first identify the cause, and then remove the cause. The cause in this example is shearing, friction, moisture, and pressure. We will remove the pressure injury causes with interventions such as using a 4 inch viscoelastic wheelchair cushion, Dycem® non-slip matting to keep the patient in place, and offloading the patient every hour while up in wheelchair. (more…)
Accurate assessment and documentation of wounds is essential for developing a comprehensive plan of care. Photography now plays a key role in wound care. The use of digital photography has enhanced the reliability and accuracy of wound documentation. Though a wound assessment in patient files includes details such as location, depth, odor, condition of surrounding tissue and other details, a visual record can be worth even more.
Digital photography is becoming a more prevalent documentation tool. According to an article published in McKnight’s, forensic nursing experts recommend using photographs to document injury. The photos show both how an injury occurred and how it is healing.
The National Pressure Ulcer Advisory Panel (NPUAP) also supports photography as a more accurate means for assessment of wound dimensions and wound base over time.
A visual confirmation to the written record, these images:
Facilitate better diagnosis
Enhance clinical documentation
Help to monitor the progress of wound healing
Help prevent litigation in wound management
Allow inter-disciplinary communication among the wound care team
Research shows that a skin-graft harvesting system aids chronic wound recovery and reduces care costs by accelerating the healing process.
More than six million cases of chronic wounds cost $20 billion each year in the United States. Diabetic ulcers, pressure sores, surgical site wounds, and traumatic injuries to high-risk patients account for most wounds that won’t heal. (more…)
The National Pressure Ulcer Advisory Panel (NPUAP) describes support surfaces as “specialized devices for pressure redistribution designed for management of tissue loads, microclimate, and/or other therapeutic functions.” These devices include specialized mattresses, mattress overlays, chair cushions, and pads used on transport stretchers, operating room (OR) tables, examination or procedure tables, and gurneys. Some support surfaces are part of an integrated bed system, which combines the bed frame and support surface into a single unit. (more…)
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 support the work of NPUAP are appreciated. (more…)
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. (more…)
On April 13, 2016, the National Pressure Ulcer Advisory Panel (NPUAP) announced changes in pressure ulcer terminology and staging definitions. Providers can adapt NPUAP’s changes for their clinical practice and documentation, but it’s important to note that, as of press time, the Centers for Medicare & Medicaid Services (CMS) has not adopted the changes. This means that providers can’t use NPUAP’s updates when completing CMS assessment forms, such as the Minimum Data Set (MDS) or Outcome and Assessment Information Set (OASIS). Instead, they must code the CMS assessment forms according to current CMS instructions and definitions. In addition, there is no ICD-10 code for pressure injury. (more…)
The panel that created the document identified 10 interventions strongly recommended for clinical practice; however, panel members noted that, “there is a paucity of reliable, well-conducted clinical trials which have produced clear evidence related to the effects of biofilm presence.” (more…)
Antibiotic resistance is a pressing public health threat not only in the United States, but worldwide. According to the World Health Organization (WHO), it is one of the major threats to human health.
Despite these concerns, antibiotics continue to be widely used—and overused. In long-term care, for instance, antibiotics are the most frequently prescribed medications, with as many as 70% of residents receiving one or more courses per year. And antibiotics are consistently ordered for suspected pressure ulcer infections.
Here is what clinicians who care for patients with wounds can do to help reduce antibiotic resistance. (more…)
Just when we think we’ve figured out pressure ulcer staging, it changes again. In April 2016, the National Pressure Ulcer Advisory Panel (NPUAP) held a consensus conference on staging definitions and terminology. The purpose: to analyze and discuss the rationale for the panel’s changes. One of the key changes is replacing the term “pressure ulcer” with “pressure injury.” So instead of calling it a pressure ulcer staging system, NPUAP will refer to it as a pressure injury staging system. The panel explained that the new terminology “more accurately describes pressure injuries to both intact and ulcerated skin.” Other changes include: (more…)