Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial

<i>Background and Objectives:</i> Patients with diabetes polyneuropathy are at a heightened risk for developing foot ulcers, often due to dynamic plantar foot pressure patterns that lead to increased pressure and shear forces in specific foot areas. This study aimed to evaluate the effec...

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Main Authors: Hany M. Elgohary, Ibtsam Allam, Ahmed M. N. Tolba, Faten Ali, Reem M. Alwhaibi, Hoda M. Zakaria, Walaa M. Ragab, Youssef Elbalawy
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Medicina
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Online Access:https://www.mdpi.com/1648-9144/60/12/2066
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author Hany M. Elgohary
Ibtsam Allam
Ahmed M. N. Tolba
Faten Ali
Reem M. Alwhaibi
Hoda M. Zakaria
Walaa M. Ragab
Youssef Elbalawy
author_facet Hany M. Elgohary
Ibtsam Allam
Ahmed M. N. Tolba
Faten Ali
Reem M. Alwhaibi
Hoda M. Zakaria
Walaa M. Ragab
Youssef Elbalawy
author_sort Hany M. Elgohary
collection DOAJ
description <i>Background and Objectives:</i> Patients with diabetes polyneuropathy are at a heightened risk for developing foot ulcers, often due to dynamic plantar foot pressure patterns that lead to increased pressure and shear forces in specific foot areas. This study aimed to evaluate the effects of foot insoles on peak pressure and the pressure–time integral in patients with polyneuropathy diabetic foot ulcers over a twelve-week period followed by an eight-week follow up. <i>Materials and Methods</i>: This was a prospective, randomized, double-blinded, controlled clinical trial involving 60 patients aged between 50 and 65 years of both genders. Inclusion criteria included midfoot ulcer grades II or III, a history of polyneuropathy diabetic foot ulcers lasting between six months and one year, diabetes duration of seven to ten years, glycated hemoglobin levels between 7% and 9%, and a body mass index (BMI) ranging from 25 to 30 kg/m<sup>2</sup>. Participants were randomly assigned to either the study group, which received foot insoles along with medication and wound care, or the control group, which received only medication and wound care. Measurements of peak pressure and pressure–time integrals were taken at the start of this study, after twelve weeks, and again eight weeks post-study. <i>Results</i>: The results indicated significant differences in peak pressure and pressure–time integral measurements for the rearfoot, midfoot, hallux, and both medial and lateral forefoot areas after twelve weeks of using foot insoles compared to the control group. This suggests that the use of foot insoles effectively reduces peak pressure and the pressure–time integral in these critical areas. <i>Conclusions</i>: The findings of this study support the use of foot insoles as a beneficial intervention for decreasing peak pressure and the pressure–time integral on the hallux, medial, and lateral forefoot in patients with polyneuropathic diabetic foot ulcers, and they could play a crucial role in preventing further complications.
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spelling doaj-art-8c3d7c2e5f6642da99640d9f3bead47d2024-12-27T14:39:02ZengMDPI AGMedicina1010-660X1648-91442024-12-016012206610.3390/medicina60122066Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical TrialHany M. Elgohary0Ibtsam Allam1Ahmed M. N. Tolba2Faten Ali3Reem M. Alwhaibi4Hoda M. Zakaria5Walaa M. Ragab6Youssef Elbalawy7Physical Therapy Department, Faculty of Applied Medical Sciences, Jerash University, Jerash 26110, JordanDepartment of Physical Therapy for Skin and Surgery, Faculty of Physical Therapy, Suez Canal University, Ismailia 41522, EgyptDepartment of Basic Science, Faculty of Physical Therapy, Delta University for Science and Technology, Gamasa 35511, EgyptDepartment of Physical Therapy for Internal Medicine and Geriatrics, Faculty of Applied Medical Science, Al al-Bayt University, P.O. Box 130040, Mafraq 24113, JordanRehabilitation Sciences Department, Health and Rehabilitation Sciences College, Princess Nourah Bint Abdulrahman University, Riyadh 11671, Saudi ArabiaDepartment of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University, Cairo 12613, EgyptDepartment of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University, Cairo 12613, EgyptDepartment of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University, Cairo 12613, Egypt<i>Background and Objectives:</i> Patients with diabetes polyneuropathy are at a heightened risk for developing foot ulcers, often due to dynamic plantar foot pressure patterns that lead to increased pressure and shear forces in specific foot areas. This study aimed to evaluate the effects of foot insoles on peak pressure and the pressure–time integral in patients with polyneuropathy diabetic foot ulcers over a twelve-week period followed by an eight-week follow up. <i>Materials and Methods</i>: This was a prospective, randomized, double-blinded, controlled clinical trial involving 60 patients aged between 50 and 65 years of both genders. Inclusion criteria included midfoot ulcer grades II or III, a history of polyneuropathy diabetic foot ulcers lasting between six months and one year, diabetes duration of seven to ten years, glycated hemoglobin levels between 7% and 9%, and a body mass index (BMI) ranging from 25 to 30 kg/m<sup>2</sup>. Participants were randomly assigned to either the study group, which received foot insoles along with medication and wound care, or the control group, which received only medication and wound care. Measurements of peak pressure and pressure–time integrals were taken at the start of this study, after twelve weeks, and again eight weeks post-study. <i>Results</i>: The results indicated significant differences in peak pressure and pressure–time integral measurements for the rearfoot, midfoot, hallux, and both medial and lateral forefoot areas after twelve weeks of using foot insoles compared to the control group. This suggests that the use of foot insoles effectively reduces peak pressure and the pressure–time integral in these critical areas. <i>Conclusions</i>: The findings of this study support the use of foot insoles as a beneficial intervention for decreasing peak pressure and the pressure–time integral on the hallux, medial, and lateral forefoot in patients with polyneuropathic diabetic foot ulcers, and they could play a crucial role in preventing further complications.https://www.mdpi.com/1648-9144/60/12/2066foot insolepeak pressurepressure–time integralpolyneuropathy diabetic foot ulcerpressure distribution
spellingShingle Hany M. Elgohary
Ibtsam Allam
Ahmed M. N. Tolba
Faten Ali
Reem M. Alwhaibi
Hoda M. Zakaria
Walaa M. Ragab
Youssef Elbalawy
Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
Medicina
foot insole
peak pressure
pressure–time integral
polyneuropathy diabetic foot ulcer
pressure distribution
title Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
title_full Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
title_fullStr Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
title_full_unstemmed Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
title_short Effect of Foot Insole on Planter Pressure Distribution in Patients with Neuropathic Diabetic Foot Ulcer: A Prospective, Randomized, Double-Blinded, Controlled Clinical Trial
title_sort effect of foot insole on planter pressure distribution in patients with neuropathic diabetic foot ulcer a prospective randomized double blinded controlled clinical trial
topic foot insole
peak pressure
pressure–time integral
polyneuropathy diabetic foot ulcer
pressure distribution
url https://www.mdpi.com/1648-9144/60/12/2066
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