Diabetic Foot Ulcer Management

Analysts have estimated that 20% of the money spent on diabetes in the United States alone is for foot care. Frost & Sullivan’s health care analysts have identified these companies as innovators in diabetic foot ulcer management.

According to the International Diabetes Federation, a diabetic foot ulcer is a disease-related complication that affects approximately 15% of the 425 million diabetics globally. An ulcer takes about 12 to 14 weeks to heal, but for 15% of affected patients medication management is not enough to tackle the severity of their condition and amputation is the only solution. The average cost of treatment ranges from $16,500 for patients without severely impaired circulation to about $63,000 for patients undergoing an amputation.

Frost & Sullivan’s Transformational Health business unit tracks the wound care market. Analysts have estimated that 20% of the money spent on diabetes in the United States alone is for foot care. The major pain points associated with ulcer management globally are the high costs of care and the lack of experts to administer care, especially in rural areas or less-developed economies. The pipeline of new products also is lacking in this relatively mature market. The standards of care for diabetic foot ulcers have remained stagnant, mostly limited to debridement, pressure offloading, infection management and revascularization.

Frost & Sullivan’s health care analysts have identified these companies as innovators in diabetic foot ulcer management.

Sanuwave Health (Suwanee, Ga.)

Sanuwave Health is a regenerative medicine company that has developed the dermaPACE system, an innovative technology that uses high-energy shock waves to manage diabetic foot ulcers. Blood vessels and nerves in the lower extremities are likely to show damage in patients suffering from diabetes for several years. By sending extracorporeal shock waves of high-energy pulses to the wound site, the company was able to stimulate cellular regeneration and wound healing using its proprietary pulse acoustic cellular expression (PACE) technology. During treatment, four to eight short bursts of the shock wave energy are applied in a non-invasive manner over a two- to 10-week period. DermaPACE showed an impressive 44% wound closure rate, compared to a mere 30% in patients who received a sham treatment, over a treatment period of 24 weeks. The unique value proposition is the platform’s immense scalability: it also can be used to stimulate soft tissues and bones for musculoskeletal regeneration.

The U.S. Food & Drug Administration (FDA) approved the dermaPACE system in January, making it the first-of-its-kind device available in the country. It has also received regulatory clearance for marketing in Europe, Canada, Australia, and New Zealand.

PulseFlow Technologies (Buckinghamshire, U.K.)

With its Class II medical device, PulseFlow DF, the company is using wearable technology to bring together two recognized treatment strategies for foot ulcer management: offloading and intermittent pneumatic compression. Offloading provides the benefits of normal gait pattern and reduces the impact of shear forces from direct loading to accelerate healing time. By using an intermittent plantar compression inflation mechanism, the company is able to improve functionality. The device unit is part of customized footwear offered to patients in nine sizes, and comes with built-in software for real-time data capture so a physician can monitor and engage with patients and schedule follow-up treatment. The ergonomically designed, lightweight footwear is also equipped with system alarms and a bioimpedance sensor that ensures functionality and patient compliance to the treatment regimen. By offering the device built into shoes in pairs, the company ensures that a patient is able to maintain good balance and normal gait, decreasing the risk of contralateral problems. Frost & Sullivan recognized that the technology empowers a patient to lead an active lifestyle while minimizing repeat tissue breakdown.

Integra LifeSciences (Plainsboro, N.J.)

With FDA approval of Integra’s Omnigraft Dermal Regeneration Template (IDRT) in 2016, the company is offering a wound closure and permanent dermis regeneration solution for diabetic foot ulcers that last longer than six weeks. The solution, when offered along with standard care for diabetes, ensures better wound healing without exposure of the joint capsule, bone or tendon. During clinical trials, 51% of patients who opted for Omnigraft IDRT experienced wound healing within six weeks, compared to 32% in patients who opted for standard care. It also demonstrated an overall wound closure rate of 59%. The silicone, cow collagen and shark cartilage components of IDRT help in cell migration, regeneration and growth of new cells by acting as a scaffold when placed in direct contact with the wound. As one of the first products approved by the FDA and European health care authorities for regeneration of dermal tissue, the company hopes to treat about 1 million diabetic foot ulcers globally every year.

The Road Ahead

Frost & Sullivan research confirms a growing demand for diabetic foot ulcer management as the global diabetic population increases to an expected 300 million by 2025. Research universities and companies are developing other innovative solutions, such as regenerative bandages, advanced wound dressing and light beam therapy for wound healing and closure.

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