Can The Active Off-Loading Insole Reinvent Care For Plantar Ulcers?

By Robi Garthwait, Contributing Editor

With the rate of diabetes cases skyrocketing and the number of lower-limb amputations also on the rise, a new insole may provide hope for those suffering the adverse effects of plantar ulcers. Used in conjunction with the company’s Active Off-Loading Walker (formerly known as the DH Walker), Woundcare Shoes or DH Pressure Relief Shoe, Royce Medical’s Active Off-Loading Insole has been deemed “the platinum solution for healing plantar ulcers.” Hoping to alleviate some of the pain and trauma associated with treating plantar ulcers, the company set out to provide an “active environment for plantar healing,” absent many of the limitations of a total contact cast. “I have used the Active Off-Loading Walker and DH shoe with the Off-Loading Insole extensively to facilitate healing neuropathic ulcers and to protect them from repetitive injury and re-ulceration once they are healed. My overall experience has been very good,” says Lawrence Lavery, DPM, an Associate Professor in the Department of Orthopaedics Surgery and Rehabilitation at Loyola University Medical Center. David G. Armstrong, DPM, concurs. “The quality of offloading that we have experienced with the Royce products, particularly the Active Off-Loading Walker, is equal to or superior to any other offloading device currently available,” notes Dr. Armstrong, a member of the National Board of Directors of the American Diabetes Association. Reducing Impact Of Shear Forces Royce Medical had several goals in mind when it created its Active Off-Loading Insole. One stated goal was to manage or reduce the shear forces that can harm the tissues of a granulating wound as well as the entire plantar surface. The creation of hexagonal suspension cells or “ActivHexs” within the insole appear to address the many problems associated with shear forces. Each insole consists of hundreds of ActivHexes that congruently adjoin along the plantar aspect of the foot to create a smooth plantar surface. According to Dr. Armstrong, “the multilaminar, multidurometer hexagonal plug inlays provide a good deal of robust force redistribution.” The company adds that the ActivHexes collectively respond by swaying independently as much as 10 to 20 degrees in response to shear forces. In essence, each ActivHex conforms to the nuance of the foot, enabling the insole to adjust and redirect shear forces to one or multiple zones in real time. How The Insole Addresses Specific Areas And Eliminates Uneven Peak Pressures Uneven weight distribution during the offloading of a granulating wound can have detrimental effects. Whether the wound itself grows or reopens, or secondary damage occurs around the wound perimeter, relieving pressure from adjacent soft tissues is of paramount concern. To address this issue, the Active Off-Loading Insole’s ActivHexes are removable, allowing for site specific offloading. In addition, using the In-Shoe F-Scan System, Royce was able to demonstrate that its insole creates no additional pressure at the wound perimeter and does not create an edge effect when the ActiveHexes are removed. Uneven peak pressures exclusive to an individual’s gait pattern occur during ambulation and can create hot spots on the patient’s plantar surface. Royce’s insole helps eliminate this problem through independent suspension delivered by the ActivHexes, which absorb vertical impact and distribute pressure evenly throughout the entire gait phase. As Dr. Lavery states, “The insole’s proven pressure reduction characteristics are the single most attractive aspect of this product.” Dr. Armstrong is similarly impressed. “In numerous trials of offloading modalities in our gait laboratory, we have not found a device that can, for all intents and purposes, provide superior pressure offloading. In fact, the Active Off-Loading Walker offloads the foot in the laboratory as well as a total contact cast in most areas of the forefoot,” explains Dr. Armstrong, the Director of Research and Education within the Department of Surgery, Podiatry Section at the Southern Arizona Veterans Affairs Medical Center in Tuscon, Ariz. Addressing Patient Compliance “The biggest problem with all removable devices is that they are removable,” notes Dr. Armstrong. “For that reason, we recommend converting many of these devices into ‘instant’ total contact casts by simply wrapping them with cohesive bandage or plaster/fiberglass casting tape to make them less easily removable.”

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