Innovation in Diabetic Foot Ulcer Treatment

A common long-term complication associated with diabetes is diabetic foot ulcer. It results from peripheral neuropathy (nerve damage) and poor blood flow caused by elevated levels of blood sugar. Since peripheral neuropathy can cause numbness, someone with diabetes might not feel a foot injury, cut or even a blister before it turns into an open wound or ulcer. Ulcers form when skin tissue breaks down exposing the layers underneath.

Once peripheral neuropathy develops, the annual incidence of ulcer formation increases from less than one percent to greater than 7 percent. [1]  The estimate of the global prevalence of diabetic foot ulcers is 6.3 percent, with a higher incidence observed in individuals with type 2 diabetes than in those with type 1 diabetes.[2]

A diabetic foot ulcer can get worse over weeks or months without someone knowing because they do not feel the pain. In the initial stages, a diabetic foot ulcer can be treated successfully, increasing the chance of a full recovery. However, in advanced stages, the risk of complications like a foot or limb amputation are high. 

The earliest signs of a diabetic foot ulcer include:[3]

·         Swelling

·         Warmth or redness of the foot

·         Skin discoloration

·         Drainable or blood on your socks or in your shoes

·         Foul-smelling odor coming from the foot

·         A tender spot on your foot

The stages of a diabetic foot ulcer

Doctors use classification and scoring systems to determine the severity of a diabetic foot ulcer and determine proper diabetic foot ulcer treatment. There are several classification systems, but the Wagner Ulcer Classification System is used most often. It uses six grades (0 to 5) that focus on the depth of the ulcer penetration, the extent of the tissue necrosis, and the presence of infection and inflammation of the bone or osteomyelitis (OM).

The Wagner Scale[4]

• Wagner Grade 0: There is no open wound, but there may be potential risk factors, such as calluses, redness or swelling, often accompanied by neuropathy. Prevention involves proper foot care and relieving pressure to prevent an ulcer from developing.
• Wagner Grade 1: A superficial ulcer that has not moved beyond the surface layers of the skin. Diabetic foot ulcer treatment focuses on removing dead tissue (debridement), controlling infection, and relieving pressure to promote healing.
• Wagner Grade 2: At this stage, deep ulcer extended to ligament, tendon, or joint capsules. At this stage, foot ulcer treatment is more aggressive. Surgery may be necessary to remove infected or damaged tissue.
• Wagner Grade 3: The wound is in a critical stage since it penetrates the bone and can be accompanied by signs of infection or bone inflammation. The foot ulcer treatment includes antibiotics, surgical removal of the nonviable tissue, and potential bone reconstruction.
• Wagner Grade 4: Partial-foot gangrene. At this stage, there is tissue death in a specific area of the foot. Intervention is urgent, and usually involves specialized wound care, restoring blood flow in blocked arteries and veins, and potentially amputation to prevent further loss of tissue.
• Wagner Grade 5: Whole-foot gangrene. This stage, damage from infection is severe throughout through the foot, requiring amputation.

Empowering patients through education and innovation

Best practices in diabetic foot care involve are multidisciplinary. They involves detection and intervention for neuropathy and vascular disease, patient self-care education, and

technological innovations such as telemedicine and wearable devices to facilitate patient monitoring and timely interventions.

In his LinkedIn blog post, “Empowering Patients: The Role of Innovation in Diabetic Foot Care,” Dr. Mikel Daniels, president, CMO and Managing Member at WeTreatFeet Podiatry,

writes that technological and clinical innovation in dealing with diabetic foot care are resulting in marked improvements in patient outcomes and experiences. Still central to these innovations is empowering patients by providing them with real-time information on their foot health. With this information, patients are better equipped to prevent foot health complications rather than react to them once they develop. For example, he points out, there are new devices that offer alerts on pressure abnormalities or changes in temperature, which can make health interventions timelier thereby averting severe issues.[5]

Innovation in treating diabetic foot ulcers

Among innovative new treatments and technologies for diabetic foot ulcers are:

Smart dressings: Breakthroughs in smart dressing technology, which are enabled by advanced materials and biosensing innovations, are addressing the limitations of conventional therapies – wound debridement, pharmacological treatment, and surgical intervention – to improve diabetic foot ulcer healing. The new innovative dressings for diabetic foot ulcers provide: [6]

·         Real-time monitoring and dynamic therapy.

·         On demand, drug release therapy, which responds to wound conditions to enhance precision treatment.

·         Internet of things (IoT)/AI integration enables personalized, intelligent wound management solutions.

Future smart dressings will target biocompatibility, self-healing, and remote monitoring.

Stem cell treatment: Stem cell therapy has emerged as a promising treatment for diabetic foot ulcers, which are difficult to treat. Stem cell therapy targets the underlying abnormal healing mechanisms, regulates cell signaling and promotes healing.

Based on a meta-analysis[7] of randomized controlled trials (RCTs) of diabetic foot ulcer stem cell treatment derived from bone marrow, peripheral blood, umbilical cord blood, adipose (fatty) tissue, or others, researchers found:

·         Stem cell therapy is a safe and effective treatment.

·         All randomized controlled trials (RCT) included adult stem cells

·         The cell type most frequently used was bone marrow-derived cells, followed by adipose derived cells

·         Local administration was common in the included RCTs

Also among stem cell therapy is placenta-derived cell therapy, which is a regenerative treatment derived from placenta cells. In another study, researchers conducted a systematic review to identify relevant research papers. The review showed the effectiveness of placental tissue samples for treating diabetic foot ulcers. The placental tissue can be applied topically, injected, or implanted, resulting in faster healing of wounds and regeneration of tissue. Studies found wounds closed quicker, healing times were shorter and outcomes were better with these treatments. [8]

Regenerative skin: Regenerative skin uses a patient’s own skin cells to create a regenerative skin graft designed to stimulate the growth of healthy tissue in chronic wounds. Last year, FDA granted breakthrough therapy designation (BTD) to PolarityBio’s SkinTE, a novel autologous (derived or transferred from the same individual’s body) heterogeneous skin construct for skin regeneration to treat Wagner grade 1 diabetic foot ulcers (DFU). .[9]

FDA Breakthrough Therapy Designation is one of the FDA’s most significant regulatory distinctions, aimed at expediting the development and review of treatments for serious or life-threatening conditions that demonstrate substantial potential to improve existing therapies.

If approved, SkinTE could aid grade 1 diabetic foot ulcer by regenerating and activating the tissues surrounding the wound to heal it completely

Extracorporeal Shock Wave Therapy (ESWT): ESWT uses high-energy sound waves applied externally to stimulate wound healing. It helps promote new blood vessel formation, tissue regeneration, and reduced inflammation.

A systematic review concluded that ESWT has the potential to improve healing in diabetic foot ulcers, although evidence at this time is insufficient to justify its use in routine clinical practice.[10]

Artificial intelligence: Over the past few decades, patients with diabetic foot ulcers who could not conveniently get to their physicians have used digital cameras to take photos of their wounds to send in for evaluation.  Now artificial-intelligence based technologies used with mobile apps are aiding the detection and monitoring of diabetic foot ulcers from captured images.

Innovative technologies employ machine learning algorithms to detect diabetic foot ulcers from foot photographs. Work is underway to refine machine learning to incorporate the classification systems for diabetic foot ulcers, as in the real-world settings, to promote AI-based diagnostics and prognostication. Also under development are prediction models of wound healing, which link the characteristics of diabetic foot ulcer images to the clinical and laboratory parameters of individual diabetic patients.[11]

Prevention for foot problems

These are just some of the innovative technologies being used or under development to detect and treat diabetic foot ulcers. Considering the elevated risk of getting a diabetic foot ulcer if you have diabetes, prevention is crucial. Proper foot care includes:

·         Check your feet daily.

·         Put feet up when sitting.

·         Trim nails carefully and treat corns and bunions with special care.

·         Avoid extreme hot and cold on your feet.

·         Take short lukewarm baths or showers and try not to scrub too hard when bathing or showering. Use a gentle cleanser.  Do not rub skin; blot it dry.

·         Use mild soaps. Fragrance free soaps to avoid irritations.

·         Make sure to dry your skin everywhere after washing. Dry well patting gently.

·         Use a humidifier during winter to add moisture back into the air.

·         Moisturize your skin. Best to moisturize right after shower or bath to lock water into your skin.

Diabetic foot ulcers are a significant health complication for many who are dealing with diabetes. Innovative technologies are emerging to aid prevention, detection and treatment.