Prospective Cohort Validation Study of a Novel Foot Offloading Device

Area of Science:

• Orthopedics
• Biomedical Engineering
• Rehabilitation Medicine

Background:

• Effective pressure offloading is critical for foot injury healing.
• Existing devices may lack customization and patient-specific support.
• Novel solutions are needed to improve patient outcomes and mobility.

Purpose of the Study:

• To evaluate the efficacy of a novel, customizable foot offloading device (PopSole) for pain relief and functional improvement in patients with chronic foot pain.
• To assess the impact of PopSole on patient-reported outcomes over a 4-week period.
• To determine the device's potential for enhancing daily activities and mobility.

Main Methods:

• Ten participants with chronic foot pain used the customizable PopSole device.
• Patients completed validated outcome questionnaires at baseline, 2 weeks, and 4 weeks.
• The device was adjusted for personalized pain area deflation, arch support, and metatarsal pad height.

Main Results:

• Significant improvements in pain and function were observed from baseline to week two (p < 0.05).
• The Foot & Ankle Ability Measure (FAAM) showed significant improvements in daily living and sports activities (p < 0.05).
• All participants reported pain relief and/or an improved ability to perform previously restricted standing activities.

Conclusions:

• The PopSole device offers rapid and sustained improvement in pain and function for individuals with chronic foot pain.
• Customizable pressure offloading and support can effectively enhance patient mobility and quality of life.
• Further research is warranted to assess long-term durability and explore applications in diabetic foot ulcer mitigation.