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      Predicting the risk of future diabetic foot ulcer occurrence: a prospective cohort study of patients with diabetes in Tanzania

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          Abstract

          Objectives

          The aim of this study was to identify the parameters that predict the risk of future foot ulcer occurrence in patients with diabetes.

          Research design and methods

          1810 (male (M)/female (F): 1012/798) patients, with no foot ulcer at baseline, participated in this study. Data from a set of 28 parameters were collected at baseline. During follow-up, 123 (M/F: 68/55) patients ulcerated. Survival analyses together with logistic regression were used to identify the parameters that could predict the risk of future diabetic foot ulcer occurrence.

          Results

          A number of parameters (HR (95% CI)) including neuropathy (2.525 (1.680 to 3.795)); history of ulceration (2.796 (1.029 to 7.598)); smoking history (1.686 (1.097 to 2.592)); presence of callus (1.474 (0.999 to 2.174)); nail ingrowth (5.653 (2.078 to 15.379)); foot swelling (3.345 (1.799 to 6.218)); dry skin (1.926 (1.273 to 2.914)); limited ankle (1.662 (1.365 to 2.022)) and metatarsophalangeal (MTP) joint (2.745 (1.853 to 4.067)) ranges of motion; and decreased (3.141 (2.102 to 4.693)), highly decreased (5.263 (1.266 to 21.878)), and absent (9.671 (5.179 to 18.059)) sensation to touch; age (1.026 (1.010 to 1.042)); vibration perception threshold (1.079 (1.060 to 1.099)); duration of diabetes (1.000 (1.000 to 1.000)); and plantar pressure at the first metatarsal head (1.003 (1.001 to 1.005)), temperature sensation (1.019 (1.004 to 1.035)) and temperature tolerance (1.523 (1.337 to 1.734)) thresholds to hot stimuli and blood sugar level (1.027 (1.006 to 1.048)) were all significantly associated with increased risk of ulceration. However, plantar pressure underneath the fifth toe (0.990 (0.983 to 0.998)) and temperature sensation (0.755 (0.688 to 0.829)) and temperature tolerance (0.668 (0.592 to 0.0754)) thresholds to cold stimuli showed to significantly decrease the risk of future ulcer occurrence. Multivariate survival model indicated that nail ingrowth (4.42 (1.38 to 14.07)); vibration perception threshold (1.07 (1.04 to 1.09)); dry skin status (4.48 (1.80 to 11.14)); and temperature tolerance threshold to warm stimuli (1.001 (1.000 to 1.002)) were significant predictors of foot ulceration risk in the final model. The mean time to ulceration was significantly (p<0.05) shorter for patients with: dry skin (χ 2=11.015), nail ingrowth (χ 2=14.688), neuropathy (χ 2=21.284), or foot swelling (χ 2=16.428).

          Conclusion

          Nail ingrowth and dry skin were found to be strong indicators of vulnerability of patients to diabetic foot ulceration. Results highlight that assessments of neuropathy in relation to both small and larger fiber impairment need to be considered for predicting the risk of diabetic foot ulceration.

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          Most cited references34

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          The Semmes Weinstein monofilament examination as a screening tool for diabetic peripheral neuropathy.

          The purpose of this systematic review is to evaluate current evidence in the literature on the efficacy of Semmes Weinstein monofilament examination (SWME) in diagnosing diabetic peripheral neuropathy (DPN). The PubMed database was searched through August 2008 for articles pertaining to DPN and SWME with no language or publication date restrictions. Studies with original data comparing the diagnostic value of SWME with that of one or more other modalities for DPN in patients with diabetes mellitus were analyzed. Data were extracted by two independent investigators. Diagnostic values were calculated after classifying data by reference test, SWME methodology, and diagnostic threshold. Of the 764 studies identified, 30 articles were selected, involving 8365 patients. There was great variation in both the reference test and the methodology of SWME. However, current literature suggests that nerve conduction study (NCS) is the gold standard for diagnosing DPN. Four studies were identified which directly compared SWME with NCS and encompassed 1065 patients with, and 52 patients without diabetes mellitus. SWME had a sensitivity ranging from 57% (95% confidence interval [CI], 44% to 68%) to 93% (95% CI, 77% to 99%), specificity ranging from 75% (95% CI, 64% to 84%) to 100% (95% CI, 63% to 100%), positive predictive value (PPV) ranging from 84% (95% CI, 74% to 90%) to 100% (95% CI, 87% to 100%), and negative predictive value (NPV) ranging from 36% (95% CI, 29% to 43%) to 94% (95% CI, 91% to 96%). There is great variation in the current literature regarding the diagnostic value of SWME as a result of different methodologies. To maximize the diagnostic value of SWME, a three site test involving the plantar aspects of the great toe, the third metatarsal, and the fifth metatarsals should be used. Screening is vital in identifying DPN early, enabling earlier intervention and management to reduce the risk of ulceration and lower extremity amputation.
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            Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality.

            The evidence base for many aspects of the management of foot ulcers in people with diabetes is weak, and good-quality research, especially relating to studies of direct relevance to routine clinical care, is needed. In this paper, we summarise the core details required in the planning and reporting of intervention studies in the prevention and management of diabetic foot ulcers, including studies that focus on off-loading, stimulation of wound healing, peripheral artery disease, and infection. We highlight aspects of trial design, conduct, and reporting that should be taken into account to minimise bias and improve quality. We also provide a 21-point checklist for researchers and for readers who assess the quality of published work.
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              A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS).

              Annual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence.
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                Author and article information

                Journal
                BMJ Open Diabetes Res Care
                BMJ Open Diabetes Res Care
                bmjdrc
                bmjdrc
                BMJ Open Diabetes Research & Care
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2052-4897
                2020
                5 May 2020
                : 8
                : 1
                : e001122
                Affiliations
                [1 ]departmentSchool of Life Sciences and Education , Staffordshire University , Stoke-on-Trent, UK
                [2 ]Muhimbili University of Health and Allied Sciences , Dar es Salaam, Tanzania
                [3 ]Abbas Medical Centre , Dar es Salaam, Tanzania
                Author notes
                [Correspondence to ] Professor Roozbeh Naemi; r.naemi@ 123456staffs.ac.uk
                Author information
                http://orcid.org/0000-0002-2998-2883
                http://orcid.org/0000-0002-7072-1271
                Article
                bmjdrc-2019-001122
                10.1136/bmjdrc-2019-001122
                7228475
                32371531
                78f40813-55ac-4202-a40f-37cd5da183a3
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 18 December 2019
                : 28 February 2020
                : 24 March 2020
                Categories
                Pathophysiology/Complications
                1506
                1869
                Custom metadata
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                foot biomechancis,foot ulcer,neuropathy,africans
                foot biomechancis, foot ulcer, neuropathy, africans

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