PriMatrix® and DFUs: New Multicenter Randomized Controlled Trial Finds Promising Outcomes

Over 34.2 million Americans have diabetes, according to the 2020 National Diabetes Statistics Report, and upwards of 15% to 25% will experience a diabetic foot ulcer (DFU) in their lifetime. These chronic non-healing wounds are not only prevalent, but they are also associated with staggeringly poor patient outcomes.

They are the leading cause of nontraumatic amputations in the U.S., which are thought to occur in 1 in 6 DFU patients, according to 2018 data, as cited by Kirsner 2018. Beyond the risk of losing a limb, they are associated with marked risk for loss of life as well.

The five-year mortality rate for DFUs is 30.5%, nearly equal to that of average cancer mortality rates (31%), according to a recent study published in the Journal of Foot and Ankle Research. Even more striking is that the five-year mortality rate for patients who undergo lower extremity amputation due to a DFU is alarmingly high at 56%.

What’s more, the standard of care of DFUs hasn’t improved much over 20 years, according a 2020 meta-analysis, which found that the percentage of ulcers healed remains as low as 33% at 12 weeks.

Given the potential severity and lasting impact DFUs can have on diabetic patients, research on better and more effective treatment and management options could greatly improve outcomes.

One of the Largest RCTs on DFUs

Dr. John Lantis, Professor and Site-Chief of Surgery at Mount Sinai Health System in New York, recently led 21 academic research centers, wound care clinics and private practices, and completed one of the largest DFU randomized controlled trials exploring the management of hard-to-heal, chronic wounds using a fetal bovine acellular dermal matrix, PriMatrix®, in combination with standard of care compared to standard of care alone.

Their study, published in the Journal of Wound Care, found that PriMatrix® plus the standard of care (SOC) was able to achieve a higher rate of complete wound closure for the management of DFUs when compared to the standard of care alone, which includes sharp debridement, infection elimination, use of dressings and offloading.

This RCT enrolled and randomized 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients. Of those, 103 patients were treated with PriMatrix® plus the SOC and 104 were treated with SOC alone.

Of this group, 161 completed the study per protocol (modified PP population, mPP) with 79 treated with PriMatrix® plus the SOC and 82 receiving the SOC alone. Patients were examined for up to 12 weeks or until their wounds reached complete closure.

Promising Results

In this study, researchers focused on patients with challenging DFUs that are more difficult to heal. For example, the average wound sizes of DFUs treated in the PriMatrix® + SOC and SOC groups were 3.60 cm² and 3.76 cm², respectively.

In addition, average wound durations were 264 days for the PriMatrix® + SOC group and 233 for the SOC group. Full-thickness wounds were also present in 96.2% and 93.2% of patients in the SOC group and PriMatrix® + SOC groups respectively.

Within the mITT population, Lantis et al found that using an average of 1.4 applications of PriMatrix (median number of 1 application), the PriMatrix® + SOC arm achieved a greater number of complete wound closures (45.6%) compared with the SOC alone (27.9%). The odds of achieving complete wound closure at 12 weeks were over two times greater for the PriMatrix® + SOC group compared to the SOC group.

The mPP population achieved similar results: The PriMatrix® + SOC group achieved complete wound closure at 59.5% compared to just 35.4% for the SOC group.

The most important finding of this study is that the PriMatrix arm achieved a higher closure rate compared to SOC alone with only one application of the product, as opposed to most other therapies on the market which use weekly applications for 12 weeks. This indicates a significant cost saving for the patients and the healthcare system.

Read the full study here.

Such findings could have great impact on patient outcomes. They could also alleviate the significant cost burden of DFUs on the healthcare system.

One study of neuropathic DFUs estimated that when associated costs of disability payments, productivity losses and various hospitalizations are factored in, annual total costs can amount to $20,570 per patient and $6.171 billion to the U.S. healthcare system.

Overall, DFUs are estimated to cost the U.S. healthcare system around $9-13 billion annually, as cited by Sen 2019.

For successful application, note the following warnings and precautions when using PriMatrix®:

• • Do not expose to chemicals or substances other than sterile, room temperature 0.9% saline.
  • Excessive heat can damage collagen. Do not hydrate in 0.9% saline warmed above room temperature. If, when hydrated, the product shrinks in size, DO NOT use the product as it may be damaged.
  • PriMatrix® should be used with caution in regions where an infection exists or is suspected. Treat any existing infection appropriately.
  • Do not resterilize as this may damage PriMatrix®.
  • Do not use if the product package is damaged or opened.
  • PriMatrix® is for single patient use only.
  • Rinse surgical gloves to remove glove powder prior to touching PriMatrix®.
  • Do not use product if past the date of expiration indicated on the product label.
  • Meshing of fenestrated PriMatrix® is not recommended.
  • PriMatrix® should not be applied directly on third degree burns.

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