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Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial
by
López-Moral, Mateo
,
Lázaro-Martínez, José Luis
,
Molines-Barroso, Raúl J.
in
Adolescent
,
Adult
,
Aged
2019
Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot.
Between June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit.
Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event.
Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot.
A total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263).
We recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence.
ClinicalTrials.gov NCT02995863.
Journal Article
Reflex zone therapy of the feet : a comprehensive guide for health professionals
\"The classic reflexology reference with new material and new illustrations\"--Provided by publisher.
A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID)
2020
Background
The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death.
Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates.
Methods/design
This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years.
Discussion
VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected.
Trial registration
Registered January 6, 2017 at ClinicalTrials.gov,
NCT03012529
.
Journal Article
Whose feet?
by
Tarsky, Sue, author
,
Tarsky, Sue. Whose are these
in
Foot Juvenile literature.
,
Animals Juvenile literature.
,
Foot.
2019
Babies can spot the differences between animals and people in this pure fun book with a built-in guessing game and underlying educational aspect. Straightforward words and appealing, large illustrations bring smiles and chortles, a perfect opportunity for parents to cuddle up with little ones.
The management of neuropathic ulcers of the foot in diabetes by shock wave therapy
by
Pascone, Michele
,
Notarnicola, Angela
,
Maggio, Giulio
in
Aged
,
Blood Vessels - physiology
,
Care and treatment
2009
Background
Diabetes is becoming one of the most common chronic diseases, and ulcers are its most serious complication. Beginning with neuropathy, the subsequent foot wounds frequently lead to lower extremity amputation, even in the absence of critical limb ischemia. In recent years, some researchers have studied external shock wave therapy (ESWT) as a new approach to soft tissue wound healing. The rationale of this study was to evaluate if ESWT is effective in the management of neuropathic diabetic foot ulcers.
Methods
We designed a randomized, prospective, controlled study in which we recruited 30 patients affected by neuropathic diabetic foot ulcers and then divided them into two groups based on different management strategies. One group was treated with standard care and shock wave therapy. The other group was treated with only standard care. The healing of the ulcers was evaluated over 20 weeks by the rate of re-epithelization.
Results
After 20 weeks of treatment, 53.33% of the ESWT-treated patients had complete wound closure compared with 33.33% of the control patients, and the healing times were 60.8 and 82.2 days, respectively (p < 0.001). Significant differences in the index of the re-epithelization were observed between the two groups, with values of 2.97 mm
2
/die in the ESWT-group and 1.30 mm
2
/die in the control group (p < 0.001).
Conclusion
Therefore, ESWT may be a useful adjunct in the management of diabetic foot ulceration.
Trial registration
Current Controlled Trials ISRCTN21800909
Journal Article
Whose feet?
by
Hess, Nina
,
Kanzler, John, 1963- ill
in
Foot Juvenile literature.
,
Animals Juvenile literature.
,
Foot.
2004
Introduces feet and describes how their differences allow animals to do special things, such as a mole's long, thick claws that are made for digging and a bat's strong feet that can hook into rocks.
Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study
2017
Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3kPa (p<0.001, 95% CI [31.1, 51.5]) for milled and 40.5kPa (p<0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices.
Clinical trial registration: ISRCTN19805071, www.ISRCTN.org.
Journal Article
Australian guideline on prevention of foot ulceration: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease
2022
Background
There are no current Australian guidelines on the prevention of diabetes-related foot ulceration (DFU). A national expert panel aimed to systematically identify and adapt suitable international guidelines to the Australian context to create new Australian evidence-based guidelines on prevention of first-ever and/or recurrent DFU. These guidelines will include for the first-time considerations for rural and remote, and Aboriginal and Torres Strait Islander peoples.
Methods
The National Health and Medical Research Council procedures were followed to adapt suitable international guidelines on DFU prevention to the Australian health context. This included a search of public databases after which the International Working Group on the Diabetic Foot (IWGDF) prevention guideline was deemed the most appropriate for adaptation. The 16 IWGDF prevention recommendations were assessed using the ADAPTE and GRADE systems to decide if they should be adopted, adapted or excluded for the new Australian guideline. The quality of evidence and strength of recommendation ratings were re-evaluated with reference to the Australian context. This guideline underwent public consultation, further revision, and approval by national peak bodies.
Results
Of the 16 original IWGDF prevention recommendations, nine were adopted, six were adapted and one was excluded. It is recommended that all people at increased risk of DFU are assessed at intervals corresponding to the IWGDF risk ratings. For those at increased risk, structured education about appropriate foot protection, inspection, footwear, weight-bearing activities, and foot self-care is recommended. Prescription of orthotic interventions and/or medical grade footwear, providing integrated foot care, and self-monitoring of foot skin temperatures (contingent on validated, user-friendly and affordable systems becoming available in Australia) may also assist in preventing DFU. If the above recommended non-surgical treatment fails, the use of various surgical interventions for the prevention of DFU can be considered.
Conclusions
This new Australian evidence-based guideline on prevention of DFU, endorsed by 10 national peak bodies, provides specific recommendations for relevant health professionals and consumers in the Australian context to prevent DFU. Following these recommendations should achieve better DFU prevention outcomes in Australia.
Journal Article