The US has a diabetic wound problem.

An estimated 1 million patients with diabetes in the US develop a foot ulcer annually. These patients have a 15-fold increased risk for amputation; the American Diabetes Association estimates that every 3 minutes and 30 seconds, a limb is amputated due to diabetes. A fifth to almost half of patients will lose additional limbs between 1 and 5 years post-surgery.

Comprehensive assessment and timely intervention are key to preventing significant complications, preserving lower extremities, and reducing the risk for mortality.

“The problem is often that clinicians don’t look at the whole patient; they just look at the hole in the patient,” said Matthew J. Regulski, DPM, director of the Wound Care Institute of Ocean County and wound care podiatry specialist at RWJBarnabas Health, both in Toms River, New Jersey.

The solution? Assess and refer.

A prompt referral to a foot and ankle podiatrist with a background in wound care is imperative, especially if a patient presents with a wound that has been open for longer than 4 weeks, with sensory loss (indicative of neuropathy), or has had prior ulcerations and/or amputations. Given the frequency of recurrence, it’s also important that primary care physicians (PCPs) work closely with a multidisciplinary team after the wound closes to prevent future complications.

Time Is Tissue

Diabetic wounds occur most often in patients with type 2 diabetes. A perfect storm of persistent systemic inflammation, tissue hypoxia, peripheral neuropathy, and hyperglycemia converges to impair wound healing, placing patients at risk for complications, hospitalization, and amputation.

“We’ve recognized that time is tissue, that the first 4-week marker of treating a diabetic foot ulcer is the most critical and telling if the ulcer will heal or not,” said Elizabeth Faust, MSN, CRNP, wound nurse practitioner, owner of Lizzie Wounds, LLC, in Douglasville, Pennsylvania, and president-elect of The Save A Leg, Save A Life Foundation.

The strategy goes well beyond the wound itself.

“You have neuropathy, biomechanical deformity, and vascular disease on top of it,” said Regulski. “When we see someone for the first time for a foot ulceration, we have to treat the biofilm (which are present in up to 80% of chronic wounds and often temporarily antibiotic-resistant), we have to take pressure off the foot, and we have to get vascular studies to see if their blood flow is good.”

As time is of the essence, clinical evaluation, pulse assessment, and probing the wound are the extent of the PCP’s initial role in this primary stage, said Ronald Sherman, DPM, MBA, a podiatric surgeon in the Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Hospital, and assistant professor of surgery at Johns Hopkins Medicine, both in Baltimore. He said that he sees patients daily whose wounds have persisted due to inappropriate or ineffective initial treatment.

A Recurrent Issue

Depending on the depth and severity of the wound, a diabetic foot ulcer might take anywhere from 3 to 20 weeks or more to heal. Factors such as congestive heart failure, peripheral artery disease, or end-stage kidney disease can interfere with proper healing, as can ongoing gait issues. 

Because recurrence is common (affecting as many as 40% of patients within a year to 60% within 3 years), posttreatment prevention is essential. 

Routine, comprehensive foot evaluations are recommended to identify early signs that predict ulcer recurrence; they include calluses, blistering, and hemorrhage — all of which might indicate that patients might not be adhering to prescribed footwear or that the footwear is causing some sort of mechanical stress.

We know that “half of all diabetic ulcers are caused by vascular disease or trauma and the other half, by the way a person with diabetes walks,” said Sherman. He recalled a patient who, for all intents and purposes, had healed. But through the use of biomechanical and motion capture technology, he and his colleagues were able to assess the patient’s pressure areas.

“The reason patients have these pressure areas is due to poor gait mechanics,” he said. Force also matters; if the shoe doesn’t fit properly, there’s friction, which produces heat, which then leads to an ulcer or callus,” he explained.

Changing the Paradigm Through Innovative Technology

In addition to ongoing foot assessment and care, early identification of new lesions, ensuring that footwear is not causing undue stress and pressure, and helping patients adhere to treatment can help prevent recurrence. Tight glycemic control and diet are critical, as are regular check-ins with foot and wound specialists.

Innovations in the field hold promise for improved patient outcomes.

When it comes to dressings, there are many standard care products to manage initial treatment of wounds, with selection based on the degree of fluid in and around the wound, the probability of wound healing, and the ability to achieve an appropriate moisture balance in the wound bed. They range from calcium alginate or gelling fiber dressings to foams and wound fillers.

Collagen is another category which has been shown to reduce harmful matrix metalloproteinases that affect proteins providing structural support to cells and tissues, protect growth factors, and promote tissue ingrowth. All of these dressings are available with different types of antimicrobial agents that target exudate bacteria. 

The FDA recently approved a bioengineered collagen dressing with Manuka honey and hydroxyapatite sheet (VERIS) for the management of acute and chronic wounds, including diabetic ulcers. Kayla Graff, CEO of SweetBio, the company responsible for developing and bringing the technology, told Medscape Medical News that the product promotes patient access because it is covered by insurance, can be sent directly to the patient’s home, dissolves daily, and may help improve compliance through repetitive behavior.

“There’s a lot of new dressings out there and one of the biggest are cellular tissue products or skinsubs, which have had a lot of fraudulent activity associated with their use,” Faust said. “The collagen/Manuka honey product is safe and provides the therapeutic index of what we desire in standard of care for diabetic foot ulcers.”

“They could not believe how quickly their wounds healed,” she said. Preliminary and postmarketing data echo Faust’s experience, with complete wound closure rates observed by week 4 in some patients.

“Another favorite product for diabetic foot ulcers is an offloading boot (Foot Defender) codesigned by Nike,” said Faust. “The company is working with centers like UCLA to conduct studies using artificial intelligence (AI) and sensing technology to determine how long patients are wearing it, if they are healing, how much they are walking, their activity levels, and degree of compliance.”

Physicians might also want to consider the SmartMat by Podimetrics, an at-home, remote monitoring device that patients step on daily, which measures temperature data and hot spots to determine early signs of inflammation and ulcer risk.

“The point is most of the current standards of care are based on the last century,” said Sherman. “Technology is evolving; it’s going to be a game changer.”

Regulski and Sherman reported having no relevant financial relationships. Graff is CEO of SweetBio. Faust reported receiving consulting/speaker fees from Smith & Nephew, SweetBio, Perceptive Solutions, HoverTech, Frontier Medical Group, Bechtel Medical LLC, Kerecis, vTail, Mölnlycke Health Care, and MediWound Ltd.

Liz Scherer is an independent health and medical journalist. She frequently reports for Medscape Medical News, Medscape Canada, and Medscape Europe.