FDA approves shock wave device for treatment of diabetic foot ulcers

On December 28, 2017, the FDA gave approval for the Dermapace System, a shock wave device intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers. The device uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. Read more.

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Diabetic foot ulcers heal faster with probiotic supplementation

Findings from a randomized controlled trial revealed that patients with a diabetic foot ulcer, who received probiotic supplementation for 12 weeks, experienced faster wound healing coupled with an improved glycemic and lipid profile compared with patients assigned a placebo. Read more.

via Healio

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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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Control your claims: Pressure ulcer/wound care management

Diabetic Foot Ulcers

One of many dreaded tags from a Centers for Medicare & Medicaid Survey is F-Tag 314 — Pressure ulcers.

CMS writes, “Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.” (more…)

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Pressure ulcer staging

By Nancy Morgan, RN, BSN, MBA, WOCN, WCC, CWCMS, DWC
Staging pressure ulcers can get tricky, especially when we’re dealing with a suspected deep-tissue injury (SDTI). The National Pressure Ulcer Advisory Panel defines an SDTI as a “purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer, or cooler as compared to adjacent tissue… Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid, exposing additional layers of tissue even with optimal treatment.” (more…)

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Managing chronic venous leg ulcers — what’s the latest evidence?

Managing chronic venous leg ulcers — what’s the latest evidence?

Chronic venous leg ulcers (CVLUs) affect nearly 2.2 million Americans annually, including an estimated 3.6% of people over the age of 65. Given that CVLU risk increases with age, the global incidence is predicted to escalate dramatically because of the growing population of older adults. Annual CVLU treatment-related costs to the U.S. healthcare system alone are upwards of $3.5 billion, which are directly related to long healing times and recurrence rates of over 50%.

CVLUs are not only challenging and costly to treat, but the associated morbidity significantly reduces quality of life. That makes it critical for clinicians to choose evidence-based treatment strategies to achieve maximum healing outcomes and minimize recurrence rates of these common debilitating conditions. These strategies, which include compression therapy, specialized dressings, topical and oral medications, and surgery, are used to reduce edema, facilitate healing, and avert recurrence. (more…)

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Management of Patients With Venous Leg Ulcers

It is well documented that the prevalence of venous leg ulcers (VLUs) is increasing, coinciding with an ageing population. Accurate global prevalence of VLUs is difficult to estimate due to the range of methodologies used in studies and accuracy of reporting.1 Venous ulceration is the most common type of leg ulceration and a significant clinical problem, affecting approximately 1% of the population and 3% of people over 80 years of age2 in westernised countries. Moreover, the global prevalence of VLUs is predicted to escalate dramatically, as people are living longer, often with multiple comorbidities. Recent figures on the prevalence of VLUs are based on a small number of studies, conducted in Western countries, and the evidence is weak. However, it is estimated that 93% of VLUs will heal in 12 months, and 7% remain unhealed after five years.3 Furthermore, the recurrence rate within 3 months after wound closure is as high as 70%.4-6 Thus, cost-effective adjunct evidence-based treatment strategies and services are needed to help prevent these ulcers, facilitate healing when they occur and prevent recurrence.

The impact of a VLU represents social, personal, financial and psychological costs on the individual and further economic drain on the health-care system. This brings the challenge of providing a standardised leg ulcer service which delivers evidence-based treatment for the patient and their ulcer. It is recognised there are variations in practice and barriers preventing the implementation of best practice. There are patients not receiving appropriate and timely treatment in the initial development of VLUs, effective management of their VLU and preventing recurrence once the VLU has healed.

Health-care professionals (HCPs) and organisations must have confidence in the development process of clinical practice guidelines and have ownership of these guidelines to ensure those of the highest quality guide their practice. These systematic judgments can assist in policy development, and decision making, improve communication, reduce errors and improve patient outcomes.

Read more at Journal of Wound Care

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Reduction of 50% in Diabetic Foot Ulcers With Stem Cells

Diabetic Foot Ulcers

MUNICH — Local injection of mesenchymal stem cells derived from autologous bone marrow shows promise in healing recalcitrant neuropathic diabetic foot ulcers, a novel study from Egypt shows.

Presenting the results at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting, Ahmed Albehairy, MD, from Mansoura University, Egypt, said: “In patients who received the mesenchymal stem cells, ulcer reduction was found to be significantly higher compared with patients on conventional treatment after both 6 weeks and 12 weeks of follow-up. This is despite the fact that initial ulcer size was larger in the stem-cell–treated group.” (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: 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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A pressure ulcer by any other name

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…)

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