A Closer Look At The Efficacy Of Bioengineered Alternative Tissues For DFUs

Melissa Skratsky, DPM, and Stephanie Wu, DPM, MSc

In recent years, the rise of bioengineered alternative tissues (BATs) has opened a new avenue toward the management of diabetic foot ulcers. These authors examine the evidence on the efficacy of these advanced wound care products.

The management of chronic diabetic wounds poses a formidable challenge to the healthcare community. In the United States, projections indicate that upward of 30.3 million individuals will be diagnosed with diabetes by 2030. Approximately 15 to 25 percent of these individuals are at risk of developing an ulceration at some point in their lifetime.1,2

   With foot ulcers accounting for one-quarter of diabetes-related hospital admissions, preceding 70 to 80 percent of diabetes-related amputations and being associated with a high rate of morbidity and mortality, it stands to reason that heroic efforts must combat this problem.2-5 The potential number of individuals suffering from chronic, recalcitrant wounds becomes even more staggering when factoring in increases in life expectancy and the incidence of comorbid states, the rise in obesity and the likelihood of recurrent ulcerations.

   Suffice it to say, this challenge is by no means short lived and treatment of diabetic foot ulcers should continue to be a major public health goal.

   Wounds of diabetic neuropathic etiology are difficult to treat even when one follows the fundamentals of good clinical care. Providing a moist wound environment, appropriate offloading of pressure sites, frequent debridement, restoring adequate blood flow to the area and eliminating the risk of infection do not guarantee definitive closure as alterations in the wound’s local biological milieu can impede healing.

   The local wound environment and the inflammatory response of a chronic ulceration are much different than that of an acute wound. Aberrations in protease regulation, cytokine release, fibroblast morphology and the composition of the extracellular matrix are all thought to play roles in the impairment of wound healing. Unfortunately, time is of the essence and the longer these ulcerations remain open, the more complicated and costly their treatment becomes and the greater the chance of developing detrimental limb- and life-threatening sequelae.

   While numerous advanced wound healing modalities are currently available, practicing clinicians are left wondering what products truly improve mean healing times and what percentage of wounds actually achieve closure in the expected 16 to 20 weeks. New biologic dressings for diabetic neuropathic ulcers seem to be introduced to the market on an almost daily basis. However, not every product has had appropriate evaluation and high-level, evidence-based research supporting or refuting the product’s use may be lacking.

   With all these questions looming and clouding physician judgment about appropriate therapeutic selection for their patients, let us take a closer look at various bioengineered alternative tissues and review the published medical literature to determine their efficacy for diabetic foot ulcerations.

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