Integra LifeSciences Holding Corporation announced positive clinical outcomes for PriMatrix Dermal Repair Scaffold for the management of hard to heal diabetic foot ulcers (DFUs). This study is one of the largest DFU randomized controlled trials (RCTs) ever completed with more than 100 patients per treatment group and demonstrated that in most cases, one application of PriMatrix plus standard of care (SOC) healed 60 percent of DFUs in 12 weeks versus 35 percent of DFUs that healed in 12 weeks with SOC for the per protocol analysis.
 
This data was recently published by lead investigator, John Lantis, M.D., FACS, from Mount Sinai Health System in New York, in the Journal of Wound Care, the definitive wound-care journal and leading source of up-to-date research and clinical information on everything related to tissue viability.
 
Diabetic foot ulceration is a major health and economic problem that significantly impacts both patients and the health care system. According to the 2020 National Diabetes Statistics Report, 34.2 million Americans have diabetes.¹ Estimates suggest that as high a number as 15 percent of patients with diabetes may develop a DFU in their lifetime.^2,3 An estimated 40 percent of patients with DFUs experience a recurrence within one year and 65 percent within five years, with 15 percent of patients undergoing an amputation during a 10-year follow-up period.⁴
 
“The hallmark of this study, which was designed to prove the clinical efficacy and safety of PriMatrix in managing DFUs, shows that PriMatrix has demonstrated statistically and, most importantly, clinically significant results against standard of care,” said John Lantis, M.D., FACS, principal investigator, professor and site chief of surgery, Mount Sinai West Hospital, Icahn School of Medicine. “The differentiating result is that, in most cases, only one application of PriMatrix is needed, underscoring the potential cost-effectiveness of using PriMatrix in managing DFUs. This marks the second prospective PriMatrix DFU study, which represents Integra’s continued commitment to addressing the significant unmet needs associated with patients suffering from chronic wounds.”
 
PriMatrix is a unique scaffold for the management of wounds that includes diabetic foot ulcers. Derived from fetal bovine dermis, this novel acellular dermal matrix provides an ideal environment to support cellular repopulation and revascularization processes critical in wound healing. PriMatrix is particularly rich in Type III collagen, a collagen found in fetal dermis that is active in developing and healing tissues.
 
“Diabetic foot ulcers are one of the most significant and devastating complications of diabetes that leave surgeons and patients with a critical need for effective solutions beyond standard of care," said Robert T. Davis, Jr., executive vice president and president, Tissue Technologies. “This recently published clinical data demonstrates that PriMatrix is an adaptable solution to address the most challenging DFUs in a single application. It also further supports PriMatrix’s clinical and economic value to our customers who are treating patients in hospitals and wound care clinics, providing strong evidence for payors to expand reimbursement coverage.”
 
References
¹ Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2020. 
² Reiber, G. E. The epidemiology of diabetic foot problems. Diabet. Med. J. Br. Diabet. Assoc. 13 Suppl 1, S6-11 (1996). 
³ Singh, N. Preventing Foot Ulcers in Patients with Diabetes. JAMA 293, 217 (2005). 
⁴ Rayman, G. et al. Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes Metab. Res. Rev. 36, e3283 (2020).