Effects of three-dimensional image based insole for healthy volunteers: a pilot clinical trial

Insoles are used to treat various foot diseases, including plantar foot, diabetic foot ulcers, and refractory plantar fasciitis. In this study, we investigated the effects of 3-dimensional image-based (3-D) insole in healthy volunteers with no foot diseases. Additionally, the comfort of the 3-D insole was compared with that of a custom-molded insole. A single-center, randomized, open clinical trial was conducted to address the effectiveness of insole use in a healthy population with no foot or knee disease. Two types of arch support insoles were evaluated for their effectiveness: a 3-D insole and a custom-molded insole. Fifty Korean volunteers participated in the study and were randomly allocated into the “3-D insole” (n = 40) or “custom-molding insole” (n = 10) groups. All subjects wore 3-D insoles or custom-molded insoles for 2 weeks. The sense of wearing shoes (Visual Analog Scale [VAS] and score) and fatigue of the foot were used to assess the insole effects at the end of the 2-week study period. The 3-D insole groups showed significantly improved sense of wearing shoes (VAS, p = 0.0001; score, p = 0.0002) and foot fatigue (p = 0.0005) throughout the study period. Although the number of subjects was different, the custom-molding insole group showed no significant changes in the sense of wearing shoes (VAS, 0.1188; score, p = 0.1483). Foot fatigue in the 3-D insole group improved significantly (p = 0.0005), which shows that a 3-D insole might have favorable effects on foot health in a healthy population. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0008100