Authors of a recent study at the Paul and Margaret Brand Research Center at Barry University School of Podiatric Medicine found therapeutic or protective footwear and insoles, coupled with additional footwear modifications and regular clinic visits, dramatically reduced the incidence of recurring foot ulcers among patients with diabetes.
Thirty-eight of 39 patients had no ulcer recurrence during the 6-month study conducted by Von M. Homer, MSc, BOCPD, and Jeffrey Jensen, DPM, FACAS, with assistance from Christina M. Pena, a podiatry student at the college in Miami Shores, Fla. Jensen was the school’s dean during the study. Homer is on the biomechanics clinical faculty and is the director of the college’s Motion Analysis Center.
Prevention for high-risk feet
“The goal of the project was to provide preventive care for the highest-risk diabetic feet, which, in turn, saves money for the state by preventing wound recurrence and amputation,” Pena said, adding that approximately 15% of diabetic patients develop foot ulcers.
The study began with 49 patients drawn from various wound care clinics in the South Florida area.
“The criteria we established for the study included patients who had non-insulin dependent diabetes mellitus, who had qualified for the Medicare Therapeutic Shoe Program and who had a healed forefoot wound within 3 months of their enrollment in the study,” Pena said.
Patients were excluded from the study if they had a history of rearfoot wound recurrence, open and unhealed wound sites and/or irregular foot types, such as Charcot foot or splay foot. Also eliminated were patients with partially amputated feet and severe fluctuating edema. Patients who had custom-made orthoses and footwear were also ruled out, as were non-ambulatory patients.
“Patients in the study with a wound that was healed within the last 3 weeks, had a previous amputation [or] multiple bony prominences with ulcerative calluses, and had more than a year-long history of recurring ulcers were deemed ‘highest risk,’” Pena said. “We monitored patients to keep track of the number of current wounds, newly developed wounds and healed wounds. The location of wounds and calluses and previous amputations, and where they were located, were also recorded.”
Offering education and rewarding compliance
Each participant was provided one pair of therapeutic shoes, one pair of diabetic inserts and a log booklet. Each day, they were to record important information such as the length of time the shoes were worn, how many hours they spent walking or whether they experienced discomfort. Patients also were to record whether they wore socks and whether they had any new areas of concern about their feet, such as redness or blistering.
During the 6-month period, patients returned to participating wound care clinics for follow-up every 30 days so Homer could assess the risk of wound recurrence and check to see if any modifications to the therapeutic or protective shoes and inserts were needed.
“All of the patients continued their routine wound-healing treatment throughout the study,” Pena said. “At each follow-up visit, their shoes and insoles were evaluated to see if modifications were necessary. Patients were monitored closely and provided specific shoe modifications based on their individual biomechanics and current and previous ulcer and callus locations.”
Throughout the study, patients were educated about the risks connected with diabetic ulcer complications. At each follow-up visit, the patients turned in their log booklets and received new ones. Patients received $25 gift cards as incentive to encourage compliance with prevention protocols, according to Pena.
Ten patients were deemed non-compliant and removed from the study. Pena noted that non-compliance is one of the main reasons for the ineffectiveness of diabetic shoe wear.
During the study, a documented wound developed in one patient who claimed he switched to sandals because his therapeutic shoes were uncomfortable.
“After this, his previously healed wound reopened,” Pena said. “His original wound had healed only a few weeks before he entered the study.”
Positive results from compliant patients
Throughout the study, the researchers found no other wound recurrences, even among high-risk patients. Homer and colleagues paid special attention to offloading previous ulcer sites in high risk patients, whose footwear modifications included extra-depth diabetic shoes, plastazote inserts, carbon fiber foot plates, Morton’s extension and met bar rockers, they reported.
Pena said the study demonstrated “the validity of the positive effects of selecting the proper footwear and offloading.” Even the high-risk patients experienced significant progress or total healing because of the application of appropriate footwear and inserts, she said.
“Patients said they noticed significant decreases in redness and blisters compared to previous years, leading us to conclude that the modifications throughout the 6-month study significantly improved how the shoes affected their feet,” Pena said.
Based on their study, Homer and colleagues concluded that current Medicare guidelines — to dispense one pair of therapeutic shoes and three inserts of durable medical equipment annually — are insufficient to stave off ulcer formation and recurrence. Having a previous ulcer puts patients with diabetes at high risk for a subsequent foot ulcer, they said.
Pena urged health care professionals to take extra precaution with these patients and to provide additional services, such as frequent shoe modifications by a orthotist, pedorthist, podiatrist or other licensed professional.
“Since time is a factor in reopening previously healed ulcers, we recommend these follow-ups and modifications at least be done in in a timely fashion,” she said.
Pena added, “Once skin closure has occurred, the healing process must be followed up, as the healing process is ongoing. These shoe modifications can also help keep new ulcers from forming.”
According to Pena, biomechanics plays a major role in callus and blister formation.
“If we can alter patients’ biomechanics by adjusting their shoe wear more frequently, we can keep these precursors from happening,” she said. “Even so, patient compliance is still the ultimate reason for success or failure of diabetic shoe wear.”– by Berry Craig
Disclosure: Homer, Jensen and Pena report no relevant financial disclosures.