What’s Next in Diabetic Foot Ulcer Treatment? 

A Keck Medicine of USC podiatric surgeon discusses how old research is informing new innovations for wound healing and ulcer care.  

Diabetic foot ulcers can be as life-threatening as cancer, but they’re not often talked about with the same urgency.  

“About 30% of people with serious foot ulcers will die within five years. For those who have had an amputation, that percentage increases to 60%-80%. This is worse than all but the most aggressive cancers,” says David G. Armstrong, DPM, a podiatric surgeon with USC Surgery, part of Keck Medicine of USC, and an internationally recognized leader in the field of diabetic foot ulcers, limb preservation, tissue repair and wound healing. 

But innovative treatments are on the way. Below, Armstrong discusses recent developments in foot ulcer care that could help improve patient care and prevent amputations. 

Better wound classification 

When it comes to managing diabetic foot ulcers, the first step in improving treatment is improving classification of the problem. “You can’t manage what you can’t measure,” Armstrong says. One of the most important breakthroughs in treatments for foot ulcers has been the “WIfI” classification system, which stands for Wound, Ischemia and foot Infection. Defining the type of wound precisely makes defining treatment plans easier and allows for more standardized care, Armstrong says. 

Hepatocyte growth factor (HGF) gene therapy 

Versions of gene therapy, used to stimulate tissue regeneration, have been used in the past to treat gangrene and end-stage disease, but the benefit of this was limited since it’s difficult — or impossible — to bring back “dead” tissues, Armstrong explains. But a nationwide clinical trial has shown some promising results for HGF gene therapy in patients with foot ulcers and peripheral artery disease. 

The idea behind the study is that HGF — when inserted into wounds with mild to moderate vascular disease, rather than completely dead tissue like gangrene — would help promote angiogenesis (new blood vessel growth) and reduce inflammation, thereby aiding wound healing. In the Phase 2 study published in Circulation: Cardiovascular Interventions, results showed faster healing and higher healing rates compared to placebo. 

“This step back broadens the indication for this therapy and appears to show a real positive signal,” says Armstrong, lead author of the study. “Things like this are what make medicine, and scientific research, so exciting: when you’re able to use things that aren’t working as well as you’d hoped in one area, but take a step back and look at it with fresh eyes to see how it might be used to solve a different problem.” 

Researchers estimate that this kind of therapy could become available to people sooner rather than later because of its long existing history of safety, Armstrong says. Additionally, due to the initial successful results, the FDA has “fast-tracked” the study, meaning it will expedite the review to bring this therapy to clinics as fast as possible. 

Smart wearable technologies 

Wearable technologies are an exciting new development in the field of wound healing, Armstrong notes. For example, a smart shoe and insole system that monitors pressure and activity after wound healing is designed to detect early warning signs before skin breakdown occurs.  

Advanced wound debridement 

New technologies are being developed to “reset” chronic wounds so that they behave more like acute wounds, Armstrong says.  

“A chronic wound is like a slow-running computer,” Armstrong explains. “Just as you would reboot a computer, we want to surgically reset the wound so that all the biological processes that are happening in the background can get set back to normal, and hopefully the wound will respond like an acute wound rather than an old, chronic wound.” 

Energy-based, ultrasound-based and plasma-based debridement tools are aiding in this process. 

Preventing recurrence  

Chronic wounds are also like cancer in that they have a high prevalence of reoccurring, Armstrong says. The idea behind treating wounds and foot ulcers is to keep the possibility of recurrence top of mind: “Just as with cancer, our patients are in remission,” Armstrong says. 

“If both the care team and the patient understand that it’s a certainty that someone’s going to get another wound in their long life, then that changes the way you treat someone,” Armstrong says. “Then the goal is not to get rid of a wound once, but to make that wound as uncommon and uncomplicated as possible.” 

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