Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Diabetic Neuropathy | Study protocol

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial

Authors: E. Q. Silva, E. Y. Suda, D. P. Santos, J. L. Veríssimo, J. S. S. P. Ferreira, R. H. Cruvinel Júnior, R. L. Monteiro, C. D. Sartor, I. C. N. Sacco

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals’ foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN.

Methods/design

The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot–ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality.

Discussion

The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot–ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks.

Trial registration

ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.
Appendix
Available only for authorised users
Literature
1.
International Diabetes Federation. IDF Diabetes Atlas. 8th ed. Brussels: International Diabetes Federation; 2017.
2.
Chey VA, Hastings MK, Commean PK, Ward SR, Mueller MJ. Intrinsic foot muscle deterioration is associated with metatarsophalangeal joint angle in people with diabetes and neuropathy. Clin Biomech. 2014;28(0):1055–60.
3.
Shun C, Chang Y, Wu H, Hsieh S, Lin W, Lin Y, et al. Skin denervation in type 2 diabetes: correlations with diabetic duration and functional impairments. Brain. 2004;127(7):1593–605.PubMedCrossRef
4.
Allen MD, Choi IH, Kimpinski K, Doherty TJ, Rice CL. Motor unit loss and weakness in association with diabetic neuropathy in humans. Muscle Nerve. 2013;48(2):298–300.PubMedCrossRef
5.
Allen MD, Kimpinski K, Doherty TJ, Rice CL. Length dependent loss of motor axons and altered motor unit properties in human diabetic polyneuropathy. Clin Neurophysiol. 2014;125(4):836–43.PubMedCrossRef
6.
Allen MD, Stashuk DW, Kimpinski K, Doherty TJ, Hourigan ML, Rice CL. Increased neuromuscular transmission instability and motor unit remodelling with diabetic neuropathy as assessed using novel near fibre motor unit potential parameters. Clin Neurophysiol. 2015;126(4):794–802.PubMedCrossRef
7.
Bus SA, Yang QX, Wang JH, Smith MB, Wunderlich R, Cavanagh PR. Intrinsic muscle atrophy and toe deformity in the diabetic neuropathic foot: a magnetic resonance imaging study. Diabetes Care. 2002;25(8):1444–50.PubMedCrossRef
8.
Boulton AJM. The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia. 2004;47:1343–53.PubMedCrossRef
9.
Ijzerman TH, Schaper NC, Melai T, Meijer K, Willems PJB, Savelberg HHCM. Lower extremity muscle strength is reduced in people with type 2 diabetes, with and without polyneuropathy, and is associated with impaired mobility and reduced quality of life. Diabetes Res Clin Pract. 2011;95(3):345–51.PubMedCrossRef
10.
Martinelli AR, Montavani AM, Nozabieli AJL, Ferreira DMA, Barela JA, Camargo MR, Fregonesi CEP. Muscle strength and ankle mobility for the gait parameters in diabetic neuropathies. Foot. 2013;23:17–21.CrossRefPubMed
11.
Leenders M, Verdijk LB, Van Der Hoeven L, Adam JJ, Van Kranenburg J, Nilwik R, et al. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013;14(8):585–92.PubMedCrossRef
12.
Guney A, Vatansever F, Karaman I, Kafadar IH, Oner M, Turk CY, et al. Biomechanical properties of Achilles tendon in diabetic vs. non-diabetic patients. Exp Clin Endocrinol Diabetes. 2015;123(7):428–32.PubMedCrossRef
13.
Watari R, Sartor CD, Picon AP, Butugan MK, Amorim CF, Ortega NRS, et al. Effect of diabetic neuropathy severity classified by a fuzzy model in muscle dynamics during gait. J Neuroeng Rehabil. 2014;11(1):11.PubMedPubMedCentralCrossRef
14.
Gomes AA, Onodera AN, Otuzi MEI, Pripas D. Electromyography and kinematic changes of gait cycle at different cadences in diabetic neuropathic individuals. Muscle Nerve. 2011;44(2):258–68.PubMedCrossRef
15.
Onodera AN, Gomes AA, Pripas D, Mezzarane RA, Sacco ICN. Lower limb electromyography and kinematics of neuropathic diabetic patients during real-life activities: stair negotiation. Muscle Nerve. 2011;44(2):269–77.PubMedCrossRef
16.
Akashi PMH, Sacco ICN, Watari R, Hennig E. The effect of diabetic neuropathy and previous foot ulceration in EMG and ground reaction forces during gait. Clin Biomech (Bristol, Avon). 2008;23(5):584–92.CrossRef
17.
Sacco ICN, Picon AP, Macedo DO, Butugan MK, Watari R, Sartor CD. Alterations in the lower limb joint moments precede the peripheral neuropathy diagnosis in diabetes patients. Diabetes Technol Ther. 2015;17(6):405–12.PubMedCrossRef
18.
Williams DSB, Brunt D, Tanenberg RJ. Diabetic neuropathy is related to joint stiffness during late stance phase. J Appl Biomech. 2007;23(4):251–60.PubMedCrossRef
19.
Sawacha Z, Guarneri G, Avogaro A, Cobelli C. A new classification of diabetic gait pattern based on cluster analysis of biomechanical data. J Diabetes Sci Technol. 2010;4(5):1127–38.PubMedPubMedCentralCrossRef
20.
Mueller MJ, Hastings M, Commean PK, Smith KE, Pilgram TK, Robertson D, et al. Forefoot structural predictors of plantar pressures during walking in people with diabetes and peripheral neuropathy. J Biomech. 2003;36:1009–17.PubMedCrossRef
21.
Halawa MR, Eid YM, El-hilaly RA, Abdelsalam MM, Amer AH. Relationship of planter pressure and glycemic control in type 2 diabetic patients with and without neuropathy. Diabetes Metab Syndr Clin Res Rev. 2018;12:99–104.CrossRef
22.
Pham H, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial. Diabetes Care. 2000;23(5):606–11.PubMedCrossRef
23.
Crawford F, Inkster M, Kleijnen J, Fahey T. Predicting foot ulcers in patients with diabetes: a systematic review and meta-analysis. Q J Med. 2007;100(2):65–86.CrossRef
24.
Bruun C, Siersma V, Guassora AD, Holstein P, Olivarius NDF. Amputations and foot ulcers in patients newly diagnosed with type 2 diabetes mellitus and observed for 19 years. The role of age , gender and co-morbidity. Diabet Med. 2013;30(8):964–72.PubMedCrossRef
25.
Sartor CD, Watari R, Pássaro AC, Picon AP, Hasue RH. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012;13(1):36.PubMedPubMedCentralCrossRef
26.
Kanchanasamut W, Pensri P. Effects of weight-bearing exercise on a mini-trampoline on foot mobility, plantar pressure and sensation of diabetic neuropathic feet; a preliminary study. Diabet Foot Ankle. 2017;8(1):1287239.PubMedPubMedCentralCrossRef
27.
Chang C-F, Chang C-C, Hwang S-L, Chen M-Y. Effects of Buerger exercise combined health-promoting program on peripheral neurovasculopathy among community residents at high risk for diabetic foot ulceration. Worldviews Evid Based Nurs. 2015;12(3):145–53.PubMedCrossRef
28.
Goldsmith JR, Lidtke RH, Shott S. The effects of range-of-motion therapy on the plantar pressures of patients with diabetes mellitus. J Am Podiatr Med Assoc. 2002;92(9):483–90.PubMedCrossRef
29.
Fayed EE, Mohamed Badr N, Mahmoud S, Hakim SA. Exercise therapy improves planter pressure distribution in patients with diabetic peripheral neuropathy. Int J PharmTech Res. 2016;9(5):151–9.
30.
Mueller MJ, Sinacore DR, Hoogstrate S, Daly L. Hip and ankle walking strategies: effect on peak plantar pressures and implications for neuropathic ulceration. Arch Phys Med Rehabil. 1994;75(11):1196–200.PubMedCrossRef
31.
Allet L, Armand S, Aminian K, Pataky Z, Golay A, de Bie RA, et al. An exercise intervention to improve diabetic patients’ gait in a real-life environment. Gait Posture. 2010;32(2):185–90.PubMedCrossRef
32.
Pataky Z, De León Rodriguez D, Allet L, Golay A, Assal M, Assal JP, et al. Biofeedback for foot offloading in diabetic patients with peripheral neuropathy. Diabet Med. 2010;27(1):61–4.PubMedCrossRef
33.
Cerrahoglu L, Koşan U, Sirin TC, Ulusoy A. Range of motion and plantar pressure evaluation for the effects of self-care foot exercises on diabetic patients with and without neuropathy. J Am Podiatr Med Assoc. 2016;106(3):189–200.PubMedCrossRef
34.
Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Pássaro AC, et al. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014;15(1):137.PubMedPubMedCentralCrossRef
35.
Francia P, Anichini R, De Bellis A, Seghieri G, Lazzeri R, Paternostro F, et al. Diabetic foot prevention: the role of exercise therapy in the treatment of limited joint mobility, muscle weakness and reduced gait speed. Ital J Anat Embryol. 2015;120(1):21–32.PubMed
36.
Mueller MJ, Tuttle LJ, Lemaster JW, Strube MJ, McGill JB, Hastings MK, et al. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013;94(5):829–38.PubMedCrossRef
37.
Dijs HM, Roofthooft JMA, Driessens MF, Bock PGE, Jacobs C, Acker KLV. Effect of physical therapy on limited joint mobility in the diabetic foot. A pilot study. J Am Podiatr Med Assoc. 2000;90(3):126–32.PubMedCrossRef
38.
Iunes DH, Rocha CBJ, Borges NCS, Marcon CO, Pereira VM, Carvalho LC. Self-care associated with home exercises in patients with type 2 diabetes mellitus. PLOS One. 2014;9(12):e114151.PubMedPubMedCentralCrossRef
39.
Zhang X, Zhang Y, Gao X, Wu J, Jiao X, Zhao J, et al. Investigating the role of backward walking therapy in alleviating plantar pressure of patients with diabetic peripheral neuropathy. Arch Phys Med Rehabil. 2014;95(5):832–9.PubMedCrossRef
40.
Melai T, Schaper NC, IJzerman TH, de Lange TLH, Willems PJB, Lima Passos V, et al. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013;6(1):41.PubMedPubMedCentralCrossRef
41.
York RM, Perell-Gerson KL, Barr M, Durham J, Roper JM. Motor learning of a gait pattern to reduce forefoot plantar pressures in individuals with diabetic peripheral neuropathy. PM R. 2009;1(5):434–41.PubMedCrossRef
42.
Kruse RL, Lemaster JW, Madsen RW. Fall and balance outcomes after an intervention to promote leg strength, balance, and walking in people with diabetic peripheral neuropathy: “feet first” randomized controlled trial. Phys Ther. 2010;90(11):1568–79.PubMedCrossRef
43.
Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia. 2008;51(11):1954–61.PubMedCrossRef
44.
Liang R, Dai X, Zuojie L, Zhou A, Meijuan C. Two-year foot care program for minority patients with type 2 diabetes mellitus of Zhuang tribe in Guangxi, China. Can J Diabetes. 2012;36(1):15–8.CrossRef
45.
46.
Bus SA, Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016;32:16–24.PubMedCrossRef
47.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–4.PubMedCrossRef
48.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krle A-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015;38(6):506–14.PubMed
49.
50.
Randelli P, Arrigoni P, Lubowitz JH, Cabitza P, Denti M. Randomization procedures in orthopaedic trials. Arthroscopy. 2008;24(7):834–8.PubMedCrossRef
51.
Bus SA, Van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, et al. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2015;32(1):16–24.
52.
Picon AP, Ortega NRS, Watari R, Sartor C, Sacco ICN. Classification of the severity of diabetic neuropathy: a new approach taking uncertainties into account using fuzzy logic. Clinics. 2012;67(2):151–6.PubMedPubMedCentralCrossRef
53.
Botega NJ, Bio MR, Zomignani MA, Garcia C, Pereira WA. Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD. Rev Saude Publica. 1995;29(5):355–63.PubMedCrossRef
54.
Sartor CD, Oliveira MD, Campos V, Ferreira JSSP, Sacco ICN. Cross-cultural adaptation and measurement properties of the Brazilian version of the Michigan neuropathy screening instrument. Braz J Phys Ther. 2018;22(3):222–30.PubMedCrossRef
55.
Shaffer S, Harrison A, Brow K, Brennan K. Reliability and validity of SEMMES-WEINSTEIN Monofilament testing in older community-dwelling adults. J Geriatr Phys Ther. 2005;28:112–3.CrossRef
56.
Bakker K, Apelqvist J, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012;28:225–31.PubMedCrossRef
57.
Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening test for peripheral neuropathy in the diabetes clinic. Diabetes Care. 2001;24(2):250–6.PubMedCrossRef
58.
Ferreira AFB, Laurindo IMM, Rodrigues PT, Ferraz MB, Kowalski SC, Tanaka C. Brazilian version of the Foot Health Status Questionnaire (FHSQ-BR): cross-cultural adaptation and evaluation of measurement properties. Clinics. 2008;63(5):595–600.PubMedPubMedCentralCrossRef
59.
Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990;45(6):M192–7.PubMedCrossRef
60.
Mickle KJ, Munro BJ, Lord SR, Menz HB, Steele JR. ISB Clinical Biomechanics Award 2009: toe weakness and deformity increase the risk of falls in older people. Clin Biomech. 2009;24(10):787–91.CrossRef
61.
Stebbins J, Harrington M, Thompson N, Zavatsky A, Theologis T. Repeatability of a model for measuring multi-segment foot kinematics in children. Gait Posture. 2006;23(4):401–10.PubMedCrossRef
62.
Giacomozzi C, Macellari V, Leardini A, Benedetti MG. Integrated pressure-force-kinematics measuring system for the characterisation of plantar foot loading during locomotion. Med Biol Eng Comput. 2000;38(2):156–63.PubMedCrossRef
63.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91.PubMedCrossRef
64.
Haukoos JS, Newgard CD. Advanced statistics: missing data in clinical research—Part 1: an introduction and conceptual framework. Acad Emerg Med. 2007;14(7):662–8.PubMed
65.
Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, et al. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2010;53(3):458–66.PubMedCrossRef
66.
De León Rodriguez D, Allet L, Golay A, Philippe J, Assal J-P, Hauert C-A, et al. Biofeedback can reduce foot pressure to a safe level and without causing new at-risk zones in patients with diabetes and peripheral neuropathy. Diabetes Metab Res Rev. 2013;29(2):139–44.PubMedCrossRef
67.
68.
Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018;6(2):130–42.PubMedCrossRef
Metadata
Title
Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial
Authors
E. Q. Silva
E. Y. Suda
D. P. Santos
J. L. Veríssimo
J. S. S. P. Ferreira
R. H. Cruvinel Júnior
R. L. Monteiro
C. D. Sartor
I. C. N. Sacco
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4115-8

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials

Study protocol

Reducing violent discipline by teachers using Interaction Competencies with Children for Teachers (ICC-T): study protocol for a matched cluster randomized controlled trial in Tanzanian public primary schools

Correction

Correction to: Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial

Study protocol

A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU

Study protocol

Modulation of gut microbiota through nutritional interventions in Behçet’s syndrome patients (the MAMBA study): study protocol for a randomized controlled trial

Study protocol

Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study