Additional Reading: Studies
Numerous clinical studies have demonstrated that custom orthotic devices can help reduce foot pain, redistribute plantar pressure, support diabetic foot care, and lower the risk of ulcer recurrence in at-risk populations when appropriately prescribed as part of a comprehensive treatment plan. Evidence from randomized controlled trials, systematic reviews, and international diabetic foot guidelines supports the use of custom orthotic interventions for pressure management, biomechanical control, and wound prevention.
Cochrane Review: Custom-Made Foot Orthoses for Foot Pain One of the most cited systematic reviews on orthotic effectiveness. The review found evidence supporting custom orthoses for several painful foot conditions, including pes cavus and rheumatoid arthritis-related foot pain. Link: https://www.cochrane.org/evidence/CD006801_custom-made-foot-orthoses-treatment-foot-pain Plantar Fasciitis Randomized Controlled Trial Custom foot orthoses significantly reduced first-step pain and average daily pain in patients with plantar fasciopathy compared with control groups. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC6052580/
CareFUL Prevention Trial A multicenter randomized controlled trial demonstrating that plantar pressure-based custom orthoses reduced ulcer occurrence in high-risk diabetic patients with neuropathy and a history of ulceration. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC4067390/ Systematic Review of Orthoses for Diabetic Ulcer Prevention This review evaluated 10 randomized controlled trials involving 1,686 patients and concluded that custom orthoses can reduce diabetic foot ulcer recurrence when compared with standard care. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC13428632/
International Working Group on the Diabetic Foot (IWGDF) Guidelines The worldwide standard for diabetic foot management. These guidelines emphasize pressure offloading as one of the most important interventions for preventing and healing diabetic foot ulcers. Link: https://iwgdfguidelines.org/wp-content/uploads/2023/07/IWGDF-2023-06-Offloading-Guideline.pdf Plantar Pressure and Ulcer Prevention Review This review found a growing body of evidence supporting plantar pressure measurement and pressure-reducing orthotic interventions for reducing diabetic ulcer recurrence. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC11292392/
Cochrane Review: Custom-Made Foot Orthoses for Foot Pain One of the most cited systematic reviews on orthotic effectiveness. The review found evidence supporting custom orthoses for several painful foot conditions, including pes cavus and rheumatoid arthritis-related foot pain. Link: https://www.cochrane.org/evidence/CD006801_custom-made-foot-orthoses-treatment-foot-pain Plantar Fasciitis Randomized Controlled Trial Custom foot orthoses significantly reduced first-step pain and average daily pain in patients with plantar fasciopathy compared with control groups. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC6052580/
CareFUL Prevention Trial A multicenter randomized controlled trial demonstrating that plantar pressure-based custom orthoses reduced ulcer occurrence in high-risk diabetic patients with neuropathy and a history of ulceration. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC4067390/ Systematic Review of Orthoses for Diabetic Ulcer Prevention This review evaluated 10 randomized controlled trials involving 1,686 patients and concluded that custom orthoses can reduce diabetic foot ulcer recurrence when compared with standard care. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC13428632/
International Working Group on the Diabetic Foot (IWGDF) Guidelines The worldwide standard for diabetic foot management. These guidelines emphasize pressure offloading as one of the most important interventions for preventing and healing diabetic foot ulcers. Link: https://iwgdfguidelines.org/wp-content/uploads/2023/07/IWGDF-2023-06-Offloading-Guideline.pdf Plantar Pressure and Ulcer Prevention Review This review found a growing body of evidence supporting plantar pressure measurement and pressure-reducing orthotic interventions for reducing diabetic ulcer recurrence. Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC11292392/