Small Intestinal Submucosa Wound Matrix for Chronic Wound Healing

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Author(s): 
Jason P. Hodde, MS, ATC/L and Reynald Allam, MD, MBA

Disclosure: This work was supported by Cook Biotech Incorporated. Dr. Allam is a paid consultant for Healthpoint, Ltd.

The native dermis is normally able to direct wound healing following damage but in chronic wounds, the dermal extracellular matrix (ECM) and cells within it are diseased and unable to provide the correct signals needed to stimulate and coordinate healing.1,2 In deep, chronic diabetic foot ulcers, pressure ulcers, or venous leg ulcers, the dermal ECM may be completely absent and wounds may not efficiently epithelialize because the wound healing signals that are usually present in the dermis have been lost. Functional ECM is essential to wound healing. The healing process is stalled if functional ECM is absent in chronic wounds. In these particular situations, therapeutic strategies must include the use of exogenous factors to act as a surrogate for the native dermis if healing is expected to occur.

The Chronic Wound Problem

The extent of the chronic wound problem and its impact on quality of life and financial impact on the worldwide economy is immense. For example, in individuals 65 years and older, venous leg ulcers affect approximately 1.69%3 of the population in the United States and cost approximately $9,600 to treat.4 In addition to the economic costs, most patients with chronic venous leg ulcers report pain (81%), itching (69%), and loss of sleep (67%) as a result of their wounds,5 as well as a significantly lower quality of life.6 Of the 13.8 million people in the United States diagnosed with diabetes,7 6% may develop foot ulcers over a 3-year period8 with an estimated annual cost of approximately $6 billion.9 More than 50% of people with diabetes and a foot ulcer are expected to develop a wound infection, and up to 20% will require some degree of amputation during the course of their disease.10 Pressure ulcers afflict approximately 15% of patients in acute care facilities11 and up to 29% in long-term care facilities,12 burdening the healthcare system with more than $8.5 billion in annual costs.13 Pressure ulcers are often associated with fatal septic infections and are reported to cause thousands of deaths each year in the United States.14
Observed together, these data indicate that chronic wounds are prevalent, costly, and have a significant negative impact on quality of life. Therefore, effective treatment strategies for chronic wounds could provide tremendous benefits to both patients and society as a whole. Unfortunately, complete healing rates for diabetic foot ulcers, venous leg ulcers, or pressure ulcers remain at approximately 25% to 50% following up to 20 weeks of treatment when standard wound care therapies and traditional synthetic dressings are used.15–17 These low rates suggest that standard of care is inadequate for many patients while highlighting the need for more aggressive management strategies in this population. Significant cost savings, decreased morbidity, and substantial increases in quality of life can be achieved with more rapid and complete ulcer healing.

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