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Gene Therapy for Non-Healing Diabetic Foot Ulcers Starts Phase III Trial

Diabetic Foot Ulcers

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…)

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Antibiotic use in pressure injury infections

antibiotic overuse pressure injury infection

Antibiotic overuse contributes to the problems of antibiotic resistance and healthcare acquired infections, such as Clostridium difficile. Antibiotic stewardship programs improve patient outcomes, reduce antimicrobial resistance, and save money. These programs are designed to ensure patients receive the right antibiotic, at the right dose, at the right time, and for the right duration. (more…)

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Pressure Injury Prevention: Managing Shear and Friction

pressure injury intervention

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…)

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Accuracy of the Ankle-brachial Index in the Assessment of Arterial Perfusion of Heel Pressure Injuries

Abstract: Background. The evaluation and treatment of heel pressure injuries are a significant and expensive sequela of the aging population. Although the workup of patients with lower extremity tissue loss usually involves an assessment of the arterial blood flow by means of noninvasive vascular testing, the results may be misleading in patients with heel pressure injuries when the ankle-brachial index (ABI) does not provide direct information about perfusion of the rearfoot. The objective of this retrospective, observational investigation was to determine if noninvasive vascular testing provides accurate and reliable results in patients with heel pressure injuries. (more…)

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Skin substitutes: Understanding product differences

Skin substitutes (also called tissuebased products and dermal replacements) are a boon to chronic wound management when traditional therapies have failed. When selecting skin substitutes for their formularies, wound care professionals have many product options—and many decisions to make.

Repair of skin defects has been a pressing concern for centuries. As early as the 15th century BC, Egyptian physicians chronicled procedures and herbal treatments to heal wounds, including xenografts (skin from another species). The practice of applying allografts (human cadaver skin) to wounds was first documented in 1503. In 1871, autologous skin grafting (skin harvested from the the person with the wound) was tried. Next came epithelial- cell seeding, which involves scraping off the superficial epithelium of healthy skin and transplanting the cells onto the wound. (more…)

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Frequently asked questions about support surfaces

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…)

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Clinician Resources: Pressure-Injuries, Ostomy, Lymphedema, Delirium

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…)

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Clinical Notes: Healing SCI Patients, antiseptics on mahout, diabetes

Electrical stimulation

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…)

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Understanding NPUAP’s updates to pressure ulcer terminology and staging

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…)

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Clinical Notes: biofilm, bariatric surgery, statins and more

Management of biofilm recommendations

The Journal of Wound Care has published Recommendations for the management of biofilm: a consensus document,” developed through the Italian Nursing Wound Healing Society.

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…)

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Clinical Notes: Moldable Skin Barrier, hypoglycemia, diabetic food ulcers

Moldable skin barrier effective for elderly patients with ostomy

A study in Gastroenterology Nursing reports that compared to a conventional skin barrier, a moldable skin barrier significantly improves self-care satisfaction scores in elderly patients who have a stoma. The moldable skin barrier also caused less irritant dermatitis and the costs for leakage-proof cream were lower.

The application of a moldable skin barrier in the self-care of elderly ostomy patients” included 104 patients ages 65 to 79 who had a colostomy because of colorectal cancer.

Risk factors for severe hypoglycemia in older adults with diabetes identified

(more…)

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