Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial

Sacco

Lavery

et al. 2020

Self Cite

Background Prevention of diabetic foot ulcers is important. Preventative treatment mostly targets and aims to improve modifiable risk factors of foot ulceration. While effectiveness of interventions in ulcer prevention has been systematically reviewed, their effectiveness in improving modifiable risk factors is unknown. Methods The available medical scientific literature in PubMed, Excerpta Medica Database, and the Cochrane database was searched for original research studies on six interventions to treat modifiable risk factors for diabetic foot ulceration (ie, education for patients; education for professionals; self‐management; pre‐ulcer treatment; orthotic interventions; and foot‐ and mobility‐related exercises). We assessed interventions for eight outcomes (ie, patients' knowledge; treatment adherence; professionals' knowledge; pre‐ulcers; mechanical stress; neuropathy symptoms; foot/ankle joint mobility; and foot function). Both controlled and noncontrolled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers and extracted and presented in evidence and risk of bias tables. Results We included 72 publications (26 with a controlled study design and 46 noncontrolled). We found that structured education may improve foot self‐care behaviour of patients, yearly foot examinations, and foot disease knowledge of health care professionals. Callus removal reduces peak plantar pressure. Custom‐made therapeutic footwear can be effective in reducing plantar pressure and may reduce callus. Foot‐ and mobility‐related exercises may improve neuropathy symptoms and foot and ankle joint range of motion, while they do not seem to reduce peak plantar pressure; evidence for their effect on foot strength is conflicting. Conclusions Structured education for patients and health care professionals, callus removal, custom‐made therapeutic footwear, and foot‐ and mobility‐related exercises may be beneficial for improving modifiable risk factors for foot ulceration. However, we generally found low quality of evidence for interventions targeting modifiable risk factors for ulceration in persons with diabetes, with frequently inconsistent or limited results available per intervention and outcome.

Section: Discussionmentioning

confidence: 99%

Treatment of modifiable risk factors for foot ulceration in persons with diabetes: a systematic review

Sacco

Lavery

et al. 2020

Self Cite

“…So rather than a shift towards an increased research priority of prevention, the prevention to healing ratio in RCTs was only 1:36 in the last 4 y. With two published trial protocols, 7,8 and some ongoing trials identified from our systematic review of the trial registries, 9 it is hoped that more than two RCTs on prevention will be published in the coming 4 y. However, the growing discrepancy over the last 4 y is concerning, and shows that diabetic foot ulcer prevention remains underexposed in research.…”

Section: Ulcer Prevention Is Still Underexposed In Researchmentioning

confidence: 99%

The future for diabetic foot ulcer prevention: A paradigm shift from stratified healthcare towards personalized medicine

Woodburn

Bus

2020

Self Cite

Prevention of diabetic foot ulcers is important to reduce the burden of diabetic foot disease. However, we found that ulcer prevention is underexposed in research and clinical practice. Barriers to explain this are seen in patient's goal‐setting; in the lack of interdisciplinary teams for ulcer prevention; in sample sizes and funding for research; in industrial engagement; and in limited understanding of ulcer development. Rather than separately solving these barriers, we propose a paradigm shift from stratified healthcare towards personalized medicine for diabetic foot disease. Personalized medicine aims to deliver the right treatment to the right patient at the right time, based on individual diagnostics. Different treatment strategies should be available for different patients, delivered in an integrated, objective, quantitative and evidence‐based approach. More than on the classical risk factors of peripheral neuropathy and peripheral artery disease, individual diagnostics should focus on modifiable risk factors for ulceration. This includes structured biomechanical and behavioral profiling, while new research with (big) data science may identify additional risk factors, such as geographical or temporal patterns in ulceration. Industry involvement can drive the development of wearable instruments and assessment tools, to facilitate large‐scale individual diagnostics. For a paradigm shift towards personalized medicine in prevention, large‐scale collaborations between stakeholders are needed. As each ulcer episode not prevented costs about €10,000 in medical costs alone, such investments can be cost‐effective. We hope to see more discussions around this paradigm shift, and increasing investments of energy and money in diabetic foot ulcer prevention in research and clinical practice.

“…Apparently, the paucity of studies in this field remains. However, with some protocols for RCTs or descriptions of interventions published recently, and some other ongoing RCTs identified in our registry search, we hope that our next update will result in more included studies of high‐quality.…”

Section: Discussionmentioning

confidence: 99%

Prevention of foot ulcers in the at‐risk patient with diabetes: a systematic review

Raspovic

Lavery

et al. 2020

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168

330

Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to help prevent both first and recurrent foot ulcers in persons with diabetes who are at risk for this complication. We searched the available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane databases for original research studies on preventative interventions. We screened trial registries for additional studies not found in our search and unpublished trials. Two independent reviewers assessed data from controlled studies for methodological quality, and extracted and presented this in evidence and risk of bias tables. From the 13,490 records screened, 35 controlled studies and 46 non‐controlled studies were included. Few controlled studies, which were of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, there is benefit for the use of daily foot skin temperature measurements, and for therapeutic footwear with demonstrated plantar pressure relief, provided it is consistently worn by the patient. For prevention of ulcer recurrence, there is some evidence for providing integrated foot care, and no evidence for a single session of education.Surgical interventions have been shown effective in selected patients, but the evidence base is small. Foot‐related exercises do not appear to prevent a first foot ulcer. A small increase in the level of weight‐bearing daily activities does not seem to increase the risk for foot ulceration. The evidence base to support the use of specific self‐management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong. The evidence is weak for the use of other, sometimes widely applied, interventions, and is practically non‐existent for the prevention of a first foot ulcer and non‐plantar foot ulcer.