|Year : 2020 | Volume
| Issue : 3 | Page : 204-208
Plantar pressure analysis and customized insoles in diabetic foot ulcer management: Case series
Avijan Sinha1, Durga Kulkarni2, Priyanka Mehendale3
1 BPT, MPT (Ortho & Sports), Consulting Physiotherapist, Deenanath Mangeshkar Hospital, Pune, India
2 BPTh, Assistant physiotherapist to Avijan Sinha, Independent clinical physiotherapy practitioner, Pune, India
3 BPTh, MPTh (Musculoskeletal Sciences), Observer, Deenanath Mangeshkar Hospital, Pune, India
|Date of Submission||21-Jul-2019|
|Date of Web Publication||1-Sep-2020|
Dr. Avijan Sinha
Advanced Wound Care, Annex Building, Phase I, Deenanath Mangeshkar Hospital, Near Mhatre Bridge, Erandwane, Pune, Maharashtra.
Source of Support: None, Conflict of Interest: None
Nonhealing diabetic foot ulcers are a major health concern, reducing the quality of life of individuals and families. It is well-known that reduction and redistribution of plantar pressure prevents ulceration or its recurrence. However, studies regarding the use of customized insoles to off-load existing ulcers are limited. This case series highlights the potential of customized insoles in improving outcomes of diabetic plantar foot ulcers in three patients. Functional Ambulation Performance Score (FAPS) and plantar pressure readings obtained from barefooted gait analysis were noted. Customized insoles were crafted using fully customized insole (Boyner insole) technology at Advanced Wound Care Department, Deenanath Mangeshkar Hospital, Maharashtra, India for every subject as necessary. Gait analysis, wearing footwear with customized insoles, was performed immediately and repeated after 2 months for comparison. All three cases presented with improved FAPS, reduced plantar pressure at wound site, and accelerated healing after 4 months.
Keywords: Diabetic complication, plantar ulcers, wound off-loading
|How to cite this article:|
Sinha A, Kulkarni D, Mehendale P. Plantar pressure analysis and customized insoles in diabetic foot ulcer management: Case series. J Diabetol 2020;11:204-8
| Introduction|| |
Diabetes instigates sensory, motor, and autonomic neuropathy. This cumulatively causes repetitive microtrauma during weight-bearing and development of diabetic foot ulcers (DFUs). Further, peripheral vascular disease, primarily caused by atherosclerotic changes, is augmented by diabetic processes. Susceptibility to infection and peripheral vascular disease inhibit healing of the injury and may lead to gangrene. Therefore, acute wounds are subjected to several risk factors due to the effect of this systemic disease on several systems, and result into delayed healing or nonhealing chronic DFUs.
The large diabetic Indian population is at risk of developing chronic wounds. Studies regarding effective, advanced, and cost-effective strategies to combat this rampant chronic wounds’ problem in India are necessary. The plantar aspect of feet develops chronic wounds because of compromised vascularity, resulting from continuous weight-bearing pressures. Reducing plantar pressure is an effective ulcer prevention strategy in neuropathic feet with impaired protective sensation and elevated plantar loads and tissue stress. However, there are limited studies that justify the benefits of customized insoles’ usage in the management of preexisting DFUs. This case series attempts to evaluate the efficacy of customized insoles in improving wound outcomes in subjects presenting with DFUs persistent for a minimum of 3 months.
| Case Report|| |
Three adults diagnosed with diabetes and presenting with plantar DFUs persistent for at least 3 months were included in this study.
Barefooted two-dimensional gait analysis was performed for each of the participants at their respective first visits. The investigators studied the foot imprints and the pressure readings recorded by the pressure sensors using GAITRite®, a gait analysis tool. The dynamic pedobarographs were used to identify peak plantar pressures during weight-bearing. Functional Ambulation Performance Scores (FAPS) were also recorded.
The investigators counseled each of the subjects separately and described the nature and course of treatment. Importance of compliance to treatment was emphasized.
Customized insoles were prepared suitable to each participant’s specific requirement. Fully customized insole (Boyner) technology was used for this purpose. The insoles were molded for each patient with the patient in static weight-bearing position. Pied fragile feet insoles were used considering the underlying neuropathy and the need of soft support. The investigators added corrective elements at particular areas under the foot, such as arch support, as required. The insoles were then molded to off-load areas with excessive pressures and wounds. Another insole with similar adjustments was prepared for the opposite foot to ensure maximum level of symmetry and to provide comfort during walking. A pair of insoles with corrections and Velcro for fixation in footwear are shown in [Figure 1] and [Figure 2]. The subjects were followed up after 4 days. The patients took a trial of the footwear with insoles, after which the customized insoles were fixed inside the footwear. Gait analysis was performed wearing footwear with customized insoles. All the patients involved in this study were on simultaneous consultation and regular follow-up with a diabetologist, vascular surgeon, and orthopedic surgeon, as required. It is important to note that concurrent mainstream treatment continued to remain a vital part of management.
The subjects used these customized insoles in their shoes regularly for 2 months. After 2 months, gait analysis was repeated to assess any changes in gait parameters.
The FAPS, peak plantar pressure readings, and findings from wound inspection for each case were compared with respective scores at the previous two visits.
| Results|| |
At the time of follow-up after 4 months of intervention, all the three cases reported either complete healing or accelerated healing rates.
The FAPS and peak pressure readings are presented in [Figure 3] and [Figure 4]. [Figure 4] shows the peak pressure values at the respective wound sites that are represented as percentage of overall peak pressure. [Figure 5]A and [B] shows the wound site of case III before and after intervention, respectively.
|Figure 3: Functional ambulation performance score (before insoles, immediately with insoles, and 2 months later with insoles)|
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|Figure 4: Peak pressure at respective wound sites (before insoles, immediately with insoles, and 2 months later with insoles)|
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|Figure 5: Case III: (A) Wound site before use of customized insoles. (B) Wound site after use of customized insoles|
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| Discussion|| |
It is evident that customized insoles were effective in achieving improved outcomes in all the three cases involved in this study. Needless to say, regular follow-up and consistent use of these insoles in footwear is imperative. Few patients may require long-term use of such insoles, and procuring a new set of insoles periodically becomes necessary to prevent ulcer recurrence. Although, a wide variety of off-loading devices have already been described to be effective in literature, such customized insoles have certain advantages over them.
Walking on an unprotected wound is detrimental to healing. Nevertheless, the advantages of optimum physical activity and risks associated with prolonged immobilization cannot be ignored. Such therapeutic insoles not only provide adequate off-loading to facilitate healing, but also allow functional activity such as walking that should be undertaken by the elderly diabetic population for overall well-being and maintenance of good health. It is recommended that these customized products should be inserted into footwear for both, indoor and outdoor usage.
Although, total contact casts (TCCs) are known to be the ideal method for off-loading plantar diabetic ulcers till date; their use has often been associated with problems including weekly change or modification, risk of ischemia, new ulcerations, foot deformities, joint stiffness, muscular atrophy and weakness, and movement restriction., Customized insoles overcome these drawbacks and require less frequent modifications compared to TCC. Regular follow-up every 3 months and review of the product as required is strongly recommended. These insoles have shown to remain effective for 1–1.5 year. Also, TCCs are not suitable for patients requiring daily applications of advanced adjunctive wound-healing therapies. Custom insoles could possibly prove to be beneficial in such cases; especially when wound areas are small enough to allow offloading using such insoles.
Adherence to wearing any prescribed off-loading device is of utmost importance. Improvement in walking has been described as the most important footwear-related characteristic, influencing adherence. FAPS improved in all the three cases after intervention with customized insoles. Another factor influencing adherence is cosmetic appearance and ease of use. The insoles were inserted within widely accepted footwear. This ensured minimum effect on the cosmesis. Also, donning and doffing of shoes with these insoles does not require any special training or experience and is easy to use.
This study underlines that customized insoles are not simply prophylactic against DFUs, but also have noteworthy therapeutic value. India is considered to be the “diabetes capital of the world.” Besides systemic conditions, inadequate and inappropriate treatment of acute wounds, lifestyle patterns, and other demographic factors (low literacy rates, poor health-care access, lack of adequate manpower, and inadequate health infrastructure) inflame the diabetic wound crisis. This strategy provides an insight into a practical solution for this challenge, considering the financial costs, lack of need of frequent follow-ups, and no hindrance to daily activities.
Although the patients were counseled regarding the importance of regular use of the product, this study was limited by the lack of frequent follow-up with subjects to ensure adherence to intervention. It may also be realized that this intervention will not be of significant advantage to off-load plantar wounds covering a large surface area of the foot. Another limitation of this intervention was that such customized insoles are not typically waterproof. Hence, it becomes very important to counsel the patients and caregivers regarding proper care of the product to ensure maximum efficacy and to extend durability of the product.
| Conclusion|| |
Customized insoles to off-load DFUs and to redistribute plantar pressures applying the biomechanical principle in conjunction with mainstream wound management strategies such as infection control, dressing of wounds, and trimming of calluses could possibly be an effective strategy to combat active plantar ulcers.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Bowering CK Diabetic foot ulcers. Pathophysiology, assessment, and therapy. Can Fam Physician 2001;47:1007-16.
Wilcox T, Newman JD, Maldonado TS, Rockman C, Berger JS Peripheral vascular disease risk in diabetic individuals without coronary heart disease. Atherosclerosis 2018;275:419-25.
Posnett J, Franks P The burden of chronic wounds in the UK. Nursing Times 2008. Available from: https://www.nursingtimes.net/the-burden-of-chronic-wounds-in-the-uk/573423.article.[Last accessed on 13 November 2019].
Paton JS, Stenhouse EA, Bruce G, Zahra D, Jones RB A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: A participant-blinded randomised controlled trial. J Foot Ankle Res 2012;5:31.
Najafi B, Grewal GS, Bharara M, Menzies R, Talal TK, Armstrong DG Can’t stand the pressure: The association between unprotected standing, walking, and wound healing in people with diabetes. J Diabetes Sci Technol 2017;11:657-67.
Mavrogenis AF, Megaloikonomos PD, Antoniadou T, Igoumenou VG, Panagopoulos GN, Dimopoulos L, et al
. Current concepts for the evaluation and management of diabetic foot ulcers. EFORT Open Rev 2018;3:513-25.
[Internet]. https://iwgdfguidelines.org/guidelines/guidelines/. 2019 [cited 16 October 2019]. Available from: https://iwgdfguidelines.org/wp-content/uploads/2019/05/03-IWGDF-offloading-guideline-2019.pdf. [Last accessed on 13 November 2019].
Van Netten JJ, Lazzarini PA, Armstrong DG, Bus SA, Fitridge R, Harding K, et al
. Diabetic foot Australia guideline on footwear for people with diabetes. J Foot Ankle Res 2018; 11:2.
Yesudian CA, Grepstad M, Visintin E, Ferrario A The economic burden of diabetes in India: A review of the literature. Global Health 2014;10:80.
Shukla VK, Ansari MA, Gupta SK Wound healing research: A perspective from India. Int J Low Extrem Wounds 2005;4:7-8.
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]