The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.
OBJECTIVE—This study was designed to test the safety, effectiveness, and costs of off-loading with a novel, off-the-shelf irremovable device in the management of diabetic foot ulceration (DFU).
RESEARCH DESIGN AND METHODS—We prospectively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic outpatients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up, number and severity of adverse events, healing time, costs and applicability of the device, and patients’ satisfaction between those randomly assigned to total contact casting (TCC; group A) or to the Optima Diab walker (group B). Deep or infected ulcers were excluded.
RESULTS—No difference between groups A and B was observed in healing rates at 12 weeks (95 vs. 85%), healing time (6.5 ± 4.4 vs. 6.7 ± 3.4 weeks), and number of adverse events (six versus four). Treatment was significantly less expensive in group B, which showed a mean reduction of costs of 78% compared with group A (P < 0.001). Practicability was more favorable in group B, with a reduction of 77 and 58% of the time required for application and removal of the devices, respectively (P < 0.001). Patients’ satisfaction with the treatment was higher in group B (P < 0.01).
CONCLUSIONS—The Optima Diab walker is as safe and effective as TCC in the management of DFU, but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot.
Neuropathic leg ulcers (NLUs) affect more than 10% of diabetic patients with peripheral neuropathy and represent the most common cause of ulceration of the leg in these patients. Though their pathogenesis is well known, related to the chronic neuropathic edema, the management of NLUs, mainly based on elastocompression, is still controversial, with lower healing rates than nondiabetic venous leg ulcers. The authors tested if a novel gel formulation, containing amino acids and hyaluronic acid (Vulnamin)gel; Errekappa, Milan, Italy), will improve the outcomes of NLUs when used together with elastocompression. Thirty patients affected by NLU were randomized into 2 groups, both treated with 4-layer elastocompressive bandaging: patients in group A were topically treated with the application of Vulnamin) gel, whereas patients in group B received only the inert gel vehicle. The healing rate at 3 months was evaluated as the primary endpoint, whereas the secondary endpoints were healing time, reduction in ulcer area and ulceration score in 4 weeks, number of infective complications, and overall satisfaction of patients. Healing rate was significantly (P < .05) higher in patients in group A when compared with those in group B; healing time, patients' satisfaction, and reduction in ulcer area and ulceration score in 4 weeks were also higher in patients in group A. However, no significant differences were found in the prevalence of infections and other adverse events. The use of Vulnamin) gel with elastocompression is safe and effective in the management of NLUs of diabetic patients.
Diabetes and aging reduce AJM although diabetes seems to reduce plantar flexion to a more specific extent. Reduced AJM is mostly associated with a previous history of FU. The evaluation of AJM is a valid and reliable ulcer risk scale that indicates which foot is at higher ulcer risk.
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