Neuropathic Ulcers Research Articles

Offloading of diabetes-related neuropathic foot ulcers at Swedish prosthetic and orthotic clinics.

This study aimed to assess (1) the use of different offloading interventions in Sweden for the healing of diabetes-related plantar neuropathic forefoot ulcers, (2) factors influencing the offloading intervention choice, and (3) the awareness of current gold standard offloading devices. An online questionnaire was distributed via SurveyMonkey to 51 prosthetic and orthotic clinics in Sweden. Thirty-five (69%) practitioners responded to the questionnaire. Eighty-six percent of the practitioners provided modified off-the-shelf footwear combined with insoles to treat diabetes-related plantar neuropathic forefoot ulcers. A total contact cast (TCC) was provided by 20% of the practitioners, and a nonremovable knee-high walker was provided by 0%. Multiple practitioner-, patient-, intervention-, and wound-related factors were considered when practitioners provided offloading interventions to patients with this type of ulcer. The majority of the practitioners did not or were unsure whether they considered TCC or a nonremovable knee-high walker to be the gold standard treatment. Practitioners mainly provided the offloading intervention that the International Working Group on the Diabetic Foot strongly recommends not be provided, namely, modified off-the-shelf footwear with insoles. In contrast, TCC and nonremovable knee-high walkers, as the gold standards, were vastly underutilised. Therefore, the pattern of providing offloading interventions was almost exactly opposite to the recommendations of evidence-based guidelines. Different factors were considered when providing offloading interventions to patients with diabetes-related plantar neuropathic forefoot ulcers. The practitioners' lack of awareness regarding gold standard devices may have contributed to the underutilisation of TCC and nonremovable knee-high walkers.

Dose-Response Relationship of Photobiomodulation Therapy on Matrix Metalloproteinase in Healing Dynamics of Diabetic Neuropathic Ulcers-An invivo Study.

Individuals with diabetic foot ulcers have overlapped the inflammatory, proliferative and remodeling phase, making the tissue vulnerable to delayed healing responses. We aimed to establish the dose-response relationship of photobiomodulation therapy of different doses and matrix metalloproteinases in the healing dynamics of diabetic neuropathic ulcers. Diabetes was induced in 126 Albino Wistar rats, and neuropathy was induced to the hind paw by a sciatic nerve injury method. An excisional wound was created on the neuropathy-induced leg. Photobiomodulation therapy of dosages 4, 6, 8, 10, 12 and 15 J cm-2 and wavelength 655 nm and 808 nm was irradiated. Photobiomodulation therapy of dosages 4, 6 and 8 J cm-2 showed better wound healing properties with optimized levels of matrix metalloproteinases-1 and 8. We observed a strong dose response in the experimental group treated with 6 and 8 J cm-2 . The findings from the present study conclude that photobiomodulation therapy of dosages 4, 6 and 8 J cm-2 is suggestive of usefulness in diabetic neuropathic ulcer healing. Markers like matrix metalloproteinases may give a clear direction on response to the therapy. Based on the findings from the present study, we recommend to validate the findings for safety and efficacy in future through human prospective randomized controlled clinical trials.

Association of knee atypical lesions with foot ulcers and a peak of kappa IgM monoclonal immunoglobulin

Association of knee atypical lesions with foot ulcers and a peak of kappa IgM monoclonal immunoglobulin

Saving the foot: Simple orthopaedic surgical intervention demonstrates improved outcomes and reduced costs

BackgroundForefoot ulceration in diabetes requires significant resources, with high cost and low rates of success. The authors present the results of tendon procedures (percutaneous toe tenotomy and percutaneous tendo-achilles lengthening) under local anaesthetic to adjust mechanics in patients with diabetic neuropathic forefoot ulceration. MethodsRetrospective review of electronic patient record of 19 patients (22 feet) undergoing local anaesthetic tendon procedures between April 2019 and April 2021 with a 12 month follow up period. Size of ulcer, rate of ulcer healing, complication rates and ulcer recurrence were recorded and compared to a population of conservatively-managed patients (14 patients, 15 feet) treated prior to the introduction of tendon procedures. All clinical information obtained from electronic patient records. ResultsAll patients undergoing tendon procedures achieved complete ulcer healing at a mean time of 3.3 weeks for toe tip ulcers (after toe tenotomy) and 4.5 weeks for metatarsal head ulcers (after Achilles lengthening). There were no admissions for diabetic foot sepsis, reduced recurrence, reduced amputation rates and no mortality.Of the conservatively managed cohort, only 3 of the 15 achieved ulcer resolution without recurrence within the 12 month study period.The cohort managed conservatively had an average cost of £ 9902 per patient, per annum. The intervention cost was £ 1211 per patient, saving an average of £ 8691 per patient, per annum with ulcer resolution (88 % reduction in costs). ConclusionSignificant patient benefit, reduction in resource use and cost saving was seen with this simple intervention, which merits full evaluation in a clinical trial. Level of EvidenceLevel-IV

The Effect of Vibration on the Acceleration of Wound Healing of Diabetic Neuropathic Foot Ulcer: A Prospective Experimental Study on Human Patients.

Diabetic foot ulcers are a common complication that occurs in approximately 15 percent of patients with diabetes mellitus. Over 60% of diabetic foot ulcers are caused by underlying neuropathy. Former studies on diabetic animals with foot wounds found that vibration platforms significantly accelerate wound healing by catalyzing epithelization, promoting angiogenesis, and enhancing muscle bulk. This result suggests that there is evidence that vibrations may accelerate diabetic neuropathic ulcer healing in human patients. However, to the best of our knowledge, the effect of vibration on the enhancements of diabetic foot ulcer healing in human patients is rarely investigated. Hence, in this work, we conducted an experimental study with human subjects to investigate whether vibration therapy, as a complement to the standard wound treatment, can accelerate the wound healing rate of diabetic neuropathic foot ulcers. In this prospective experimental study, 80 participants diagnosed with Wagner grades I−III diabetic neuropathic foot ulcers were randomly distributed to experimental (n = 40) and control groups (n = 40). Patients in the intervention group received standard wound treatment and vibration wound therapy (VWT), whereas patients in the control group retrieved only standard wound treatment. The results (p = 0.024, α = 0.05) show notable differences in the median healing rate between the intervention group (25 days, 95% CI: 20.3−29.7) and control group (33 days, 95% CI: 25.6−40.4), with the effect-size r, Cohen’s d, Glass’s Δ, and Hedges’ g, respectively, being 0.810, 2.764, 2.311, and 2.772. Moreover, the nitric oxide (NO) level, wound closure area, and wound healing score after intervention significantly differed between the two groups (p < 0.05), putting the intervention group on a higher level than the control group. Furthermore, positive associations were found between the NO level and wound healing closure rates. These findings suggested that VWT enhances diabetic neuropathic foot ulcer healing in terms of healing rate, wound closure area, healing score, and elevated NO level. Considering that no clinically adverse effects were found in the patients induced with vibration intervention, VWT can be regarded as a complementary therapy to the existing ones to accelerate the healing of DFUs.

Is Revascularization the Only Mode of Treatment for Diabetic Foot Ulcer?

Introduction and Objective: Diabetic foot infection is a common cause for hospital admissions among diabetics in India. This could be attributed to sociocultural practices, such as walking barefoot, inequitable access to diabetes care, poor education, and poor socioeconomic conditions. The purpose of this study is to highlight the role of diabetic footwear in care of diabetic foot. Materials and Methods: The observational study included 170 patients, presenting with diabetic foot ulcers, studied over a period of 19 months. The patients were categorised in those suffering from neuropathic ulcers and neuroischemic ulcers using biothesiometery and Ankle Brachial Pressure Index. Diabetic foot wears were prescribed based on plantar pressure measurement. The mode of management was noted and need for incidence on follow up was recorded. Results: Our study population predominantly consisted of elderly males with a mean age of 63.2 years and 71.7 % males. Out of 170 patients presenting with diabetic foot ulcer, neuroischemic ulcers were diagnosed in 35 patients, and the rest 135 patients were diagnosed to have neuropathic ulcers. (Graph 1) NIU was observed more common among male patients with 25 males out of 35 patients [71.4 %], similarly NPU were more common in males [72.8 %]. Among the 35 patients who were diagnosed to have neuroischemic ulcers, all required diabetic foot wear, however 10 patients required revascularization procedure, 2 patients required Prostaglandin therapy infusion and 1 patient required stem cell implantation. The group of patients who were diagnosed to have neuropathic ulcers, required only diabetic foot wear and medical therapy which involved antibiotics, antiplatelets, vasodilators and Prostaglandin infusion. Amputation was required in 8 (23%) out of 35 patients suffering from NIU and in 12 (9%) out of 135 patients suffering from NPU. Conclusion: ABI, bioethesiometry and plantar pressure measurement play an important role in planning management and need of diabetic foot wear. Majority of the patients may have neuropathic involvement with recurrence rate and need of amputation significantly reduced by use of diabetic foot wear.

Prediction of Diabetic Neuropathy Using Machine Learning Techniques

Peripheral polyneuropathy is one of the most common complications in patients with diabetes mellitus, and it results in neuropathic pain, falling tendency, and foot ulcers as well as sensory and motor impairments. Numerous risk factors for diabetic neuropathy had been revealed through statistical analysis; however, statistics draw population inferences and might not be suitable for providing realtime prediction for each patient in clinical practice. Machine learning techniques were developed to find any predictive patterns based on input data. Such strategies can help predict neuropathy in diabetic patients, enabling prevention or early treatment to increase quality of life in diabetic patients. This article summarizes recent studies concerning the prediction of diabetic neuropathy using machine learning techniques, and suggests approaches for useful translation of these methods in the medical field.

The pressure time integral: An underused, clinically significant parameter as a determinant of neuropathic ulceration in diabetes

BackgroundThe purpose of this study was to evaluate plantar pressure dynamics in the occurrence of active diabetic neuropathic ulceration (DNU) and any changes in loadings occurring in individuals with a history of diabetic neuropathic ulceration (DHNU). Since current gold standard offloading strategies are not producing desirable healing outcomes and optimum ulcer prevention, this study aimed to better understand the effect of diabetic peripheral neuropathy (DPN) and ulceration on mean peak plantar pressure (MPPP) and pressure-time integral (PTI) changes. Research questionIs there a redistribution of plantar pressure during gait in the presence of active and history of diabetic neuropathic ulceration? MethodsA prospective, cross-sectional study was conducted, in which, eighty adult participants were divided into four groups, namely, the DM, DPN, DNU and DHNU groups. Participants were instructed to walk barefoot over a Tekscan HR Mat™ at self-selected speed. MPPP and PTI data were analysed under five forefoot anatomical landmarks and compared between individuals with and without active neuropathic ulceration. ResultsMinimal MPPP significant changes were observed between ulcerated and non-ulcerated groups, however, PTI values were significantly increased in the ulcerated groups under all plantar ulceration regions. No significant plantar pressure differences were observed between the DNU and DHNU groups. Logistic regression tests demonstrated that as PTIs under the hallux increase, the likelihood of an individual living with DPN developing ulceration increases. SignificanceA significant increase in PTI values in the presence of ulceration highlights the importance of evaluating the duration of loads under forefoot regions during gait rather than just focusing on the magnitude of pressures during ulcer management and prevention. Moreover, results show that PTI values remain high in the presence of a history of neuropathic ulceration, possibly demonstrating the value of PTI as a clinical tool over MPPP in the assessment of the high-risk diabetic foot.

Dose-response relationship of photobiomodulation therapy and oxidative stress markers in healing dynamics of diabetic neuropathic ulcers in Wistar rats

Purpose:Diabetic foot ulcers are reported to be the most expensive complications of diabetes, with high morbidity and mortality rates. If the necessary care is not provided for the wound to heal, the individual may end up amputating the affected feet. Photobiomodulation therapy is a promising non-pharmacological treatment option for wound healing. The objective of the present study is to establish a dose-response relationship between photobiomodulation therapy and oxidative stress markers in the healing dynamics of diabetic neuropathic ulcers in Wistar rats.Methodology:Diabetic neuropathy was induced in 126 Albino Wistar rats. An excisional wound of an area of 2cm2 was made on the neuropathy-induced leg. Photobiomodulation therapy of dosages 4, 6, 8, 10, 12, and 15 J/cm2 of wavelengths 655 and 808 nm was irradiated. The control group animals were kept un-irradiated. The outcome measures were assessed during wound healing’s inflammatory, proliferative and remodelling phases.Results:In the experimental group, animals treated with photobiomodulation therapy at doses of 4, 6, and 8 J/cm2 showed better wound healing dynamics. Photobiomodulation therapy modulated the reactive oxygen species and antioxidant levels, thereby improving the oxidative status of the wound.Conclusion:Photobiomodulation therapy of dosages 4, 6, and 8 J/cm2 is effective and is a promising adjuvant modality in treating diabetic neuropathic ulcers. There was a strong dose-response relationship in the experimental groups treated with 4, 6 and 8 J/ cm2.

Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes: a series of N-of-1 trial study protocol

BackgroundFoot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy.MethodsThis study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants’ self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis.DiscussionThis is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants’ preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020

RECONSTRUCTION OF PLANTAR SURFACE OF FOOT USING MEDIAL PLANTAR ARTERY FLAP- A CASE SERIES

Background: Reconstruction of weight bearing region of plantar foot defects present a challenge to surgeons because of lack of the options available and requirement of durable tissue. Among the limited options available medial plantar artery ap serve an ideal one. It can be raised in antegrade as well as retrograde fashion. In its anterograde form it is used for heel reconstruction and in retrograde form it is used for the reconstruction of the forefoot defect. The aim of this article is to assess Aim: the outcome of using medial plantar artery ap for reconstruction of heel and forefoot defect with a focus on ap survival, donor site morbidity and functional outcome. In the present study, we Material and method: present our experience with the use of medial plantar artery ap to cover plantar foot defect in the weight bearing region. Total of 12 patients, those underwent medial plantar artery ap re-construction, from January 2018 to January 2022 were included in this study. Out of the 12 patients Result: with the medial plantar artery aps, 10 were male and 2 were female. The indications for surgery were, traumatic tissue loss, unstable scar over previous grafted skin, neuropathic ulcer. All the aps survived, without major complications and provided adequate wound coverage with minimal donor site morbidity. Medial plantar artery ap for reconstruction of heel and forefoot i Conclusion: s associated with a very high ap survival rate with very few ap related complications including donor site complications.

Abstract #1318927: Prevalence of Neuropathy and its Associated Factors Among Patients With Diabetes Presenting to the Specialist Diabetes and Endocrine Center in Taif, Saudi Arabia: Cross-Sectional Study

One in every 5 diabetes patients has moderate-to-severe peripheral neuropathy. Peripheral neuropathy causes sensory loss and, hence, neuropathic ulcers and limb loss. This study aims to evaluate the prevalence of such a common and morbid neuropathy complication in a sample of Saudi diabetic patients.

A Pilot Study Comparing a Micronized Adipose Tissue Niche versus Standard Wound Care for Treatment of Neuropathic Diabetic Foot Ulcers.

Numerous studies have demonstrated the various properties of micronized adipose tissue (MAT), including angiogenic, anti-inflammatory, and regenerative activities, which can be helpful in wound healing. This exploratory clinical trial aimed to report the efficacy and safety of MAT niche for treating diabetic foot ulcers. Twenty subjects were randomly divided into MAT niche treatment (n = 10) and control groups (n = 10). All patients were followed up weekly for 16 weeks. We evaluated the efficacy of the MAT niche treatment by assessing the (1) reduction in wound area after 4 weeks and (2) percentage of patients who achieved complete wound closure after 16 weeks. All possible adverse events were recorded. The wound area was reduced by 4.3 ± 1.0 cm2 in the treatment group and by 2.0 ± 1.1 cm2 in the control group (p = 0.043). Complete wound healing was achieved after 16 weeks in eight out of 10 patients (80%) in the treatment group and three out of six (50%) in the control group (p = 0.299). No serious adverse events related to MAT niche treatment were observed. Although the present study’s findings do not support the use of this therapy to treat foot ulcers of patients with diabetes owing to the small number of patients included and the absence of statistical significance, the results of this pilot preliminary study are promising in that MAT niche autografts may offer the possibility of a simple and effective treatment for diabetic ulcers. Further follow-up studies with a larger number of patients are required to validate our findings.

Radiographic Bone Healing in Minimally Invasive Floating Metatarsal Osteotomy for Neuropathic Plantar Metatarsal Head Ulcers - A Retrospective Cohort Study.

Minimally invasive floating metatarsal osteotomy is an option for treating neuropathic ulcers under the metatarsal heads. This study presents the radiographic results of the floating metatarsal osteotomy. We reviewed files and radiographs at least 4 months after a floating metatarsal osteotomy in patients with diabetic neuropathy. In 71 osteotomies in 54 patients with late onset diabetes (mean age 61 ± 9, mean HbA1c 7.9 ± 1.9%), the primary ulcer healed within 3.5 ± 1.4 weeks. Of 66 osteotomies where radiographs were available 10 had non-union (15%, all asymptomatic), 15 (23%) had hypertrophic callus formation and 41 (62%) had normal union. One patient developed an ulcer under the hypertrophic callus. This necessitated callus resection. Asymptomatic non-union may happen in 15% of floating osteotomies, but the osteotomies appear to be relatively safe and effective for neuropathic plantar metatarsal head ulcers. Hypertropic callus causing local re-ulceration is rare and can be managed surgically.

105. Clinical outcomes of C2 nerve root sacrifice and the feasibility of its preservation in patients with congenital atlantoaxial instability

<h3>BACKGROUND CONTEXT</h3> Posterior C1-C2 fusion is a widely used fixation technique for atlantoaxial dislocation (AAD). The C2 ganglion is a restricting factor to easy access of C1-C2 joints, and placement of C1 lateral mass screws. Both intentional C2 nerve root sectioning as well as its preservation have been described and are still debatable. The associated complications and outcomes have been less studied, particularly in congenital AAD. <h3>PURPOSE</h3> To study clinical outcome after C2 nerve root sectioning as well as the feasibility of its preservation in AAD patients. <h3>STUDY DESIGN/SETTING</h3> Retrospective study/ tertiary care center. <h3>PATIENT SAMPLE</h3> This study included 190 patients who underwent posterior C1-C2 fusion for congenital AAD. <h3>OUTCOME MEASURES</h3> C2 nerve-related dysfunction; feasibilty of nerve root preservation. <h3>METHODS</h3> This is a retrospective study of 190 patients who underwent posterior C1-C2 fusion for congenital AAD using C1 lateral mass screws. The decision to cut or preserve C2 nerve root was dependent on preoperative radiology and intraoperative suitability of its preservation. Patients were followed-up at periodic intervals and questioned about C2 nerve-related dysfunction. <h3>RESULTS</h3> Complex C1-C2 morphology with highly deformed joints was seen in 139 patients. In 178 patients, the C2 nerve root was sectioned. Postoperative numbness, paresthesia and dysesthesia were present in 30.3%, 21.9% and 19.1% patients respectively. However, the symptoms were bothersome in none. They neither required medications nor disturbed the daily activities of patients. Noticeably, 9 patients (5.1%) developed non-healing occipital ulcers; most needed surgical intervention in the form of a flap cover/skin graft. C2 nerve root preservation is feasible with robust inferior C1 lateral mass and normal sized ganglion. In patients with C1-occipital condyle hypoplasia, highly oblique joints, incurved occiput, pseudofacets and anomalous vertebral artery, its preservation is technically difficult. <h3>CONCLUSIONS</h3> Though C2 nerve root sectioning did not disable the quality of life in many, a subset of patients was prone for neuropathic ulcers. Hence, its preservation should be attempted whenever feasible. It may be possible to preserve it in less complex anomalies/favorable anatomy. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

The Peripheral Neuropathy Prevalence and Characteristics Are Comparable in People with Obesity and Long-Duration Type1 Diabetes.

IntroductionPeripheral neuropathy is reported in obesity even in the absence of hyperglycaemia.ObjectiveTo compare the prevalence and characterise the phenotype of peripheral neuropathy in people living with obesity (OB) and long-duration type 1 diabetes (T1D).Patients and MethodsWe performed a prospective cross-sectional study of 130 participants including healthy volunteers (HV) (n = 28), people with T1D (n = 51), and OB (BMI 30–50 kg/m2) (n = 51). Participants underwent assessment of neuropathic symptoms (Neuropathy Symptom Profile, NSP), neurological deficits (Neuropathy Disability Score, NDS), vibration perception threshold (VPT) and evaluation of sural nerve conduction velocity and amplitude.ResultsPeripheral neuropathy was present in 43.1% of people with T1D (age 49.9 ± 12.9 years; duration of diabetes 23.4 ± 13.5 years) and 33.3% of OB (age 48.2 ± 10.8 years). VPT for high risk of neuropathic foot ulceration (VPT ≥ 25 V) was present in 31.4% of T1D and 19.6% of OB. Participants living with OB were heavier (BMI 42.9 ± 3.5 kg/m2) and had greater centripetal adiposity with an increased body fat percentage (FM%) (P < 0.001) and waist circumference (WC) (P < 0.001) compared to T1D. The OB group had a higher NDS (P < 0.001), VAS for pain (P < 0.001), NSP (P < 0.001), VPT (P < 0.001) and reduced sural nerve conduction velocity (P < 0.001) and amplitude (P < 0.001) compared to HV, but these parameters were comparable in T1D. VPT was positively associated with increased WC (P = 0.011), FM% (P = 0.001) and HbA1c (P < 0.001) after adjusting for age (R2 = 0.547). Subgroup analysis of respiratory quotient (RQ) measured in the OB group did not correlate with VPT (P = 0.788), nerve conduction velocity (P = 0.743) or amplitude (P = 0.677).ConclusionThe characteristics of peripheral neuropathy were comparable between normoglycaemic people living with obesity and people with long-duration T1D, suggesting that metabolic factors linked to obesity play a pivotal role in the development of peripheral neuropathy. Further studies are needed to investigate the mechanistic link between visceral adiposity and neuropathy.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02208-z.

Neuropathic ulcers in leprosy: clinical features, diagnosis and treatment.

Leprosy is a neglected disease caused by Mycobacterium leprae and Mycobacterium lepromatosis, and is related to significant disabilities resulting from the neural damage generated by this mycobacteria. Neuropathic ulcers-lesions that can appear at the plantar and extra-plantar levels-are one such disability, and diagnosis requires an adequate dermatological, neurological and microbiological evaluation. The treatment of these lesions is based on a multidisciplinary approach that includes debridement of the necrotic tissue, controlling infections, reducing pressure areas, optimising blood flow, and nerve decompression. This review aims to describe the clinical features, diagnostic methods and treatment of neuropathic ulcers in leprosy. The diagnostic methods and medical management used in leprosy ulcers are based on those used for diabetic foot. This requires radical change as these diseases are immunologically and physiologically very different.

Wearable medical apparatus to monitor temperature and pulsatile-blood-flow signal on forefoot to predict diabetic foot ulcers

PurposeThe purpose of this paper is to develop a prototype of a wearable medical device in the form of a bandage with a real-time data monitoring platform, which can be used domestically for diabetic patients to identify the possibility of foot ulceration at the early stage.Design/methodology/approachThe prototype can measure blood volumetric change and temperature variation in the forefoot area simultaneously. The waveform extracted using a pulsatile-blood-flow signal was used to assess blood perfusion-related information, and hence, predict ischemic ulcers. The temperature difference between ulcerated and the reference was used to predict neuropathic ulcers. The medical device can be used as a bandage during the application wherein the sensory module is placed inside the hollow pocket of the bandage. A platform was developed through a mobile application where doctors can extract real-time information, and hence, determine the possibility of ulceration.FindingsThe height of the peaks in the pulsatile-blood-flow signal measured from the subject with foot ischemic ulcers is significantly less than that of the subject without ischemic ulcers. In the presence of ischemic ulcers, the captured waveform flattens. Therefore, the blood perfusion from arteries to the tissue of the forefoot is considerably low for the subject with ischemic ulcers. According to the temperature difference data measured over 25 consecutive days, the temperature difference of the subject with neuropathic ulcers occasionally exceeded the 4 °F range but mostly had higher values closer to the 4 °F range. However, the temperature difference of the subject who had no complications of neuropathic ulcers did not exceed the 4 °F range, and the majority of the measurements occupy a narrow range from −2°F to 2 °F.Originality/valueThe proposed prototype of wearable medical apparatus can monitor both temperature variation and pulsatile-blood-flow signal on the forefoot simultaneously and thereby predict both ischemic and neuropathic diabetes using a single device. Most importantly, the wearable medical device can be used domestically without clinical assistance with a real-time data monitoring platform to predict the possibility of ulceration and the course of action thereof.

Offloading devices for neuropathic foot ulcers in adult persons with type 1 or type 2 diabetes: a rapid review with meta-analysis and trial sequential analysis of randomized controlled trials.

IntroductionHealing time for neuropathic planter foot ulcers (NPFUs) in persons with diabetes may be reduced through use of non-removable fiberglass total contact casting (F-TCC) compared with removable cast walkers (RCWs), although the evidence base is still growing.Research design and methodsWe conducted a rapid review and systematically searched for, and critically assessed, randomized controlled trials (RCTs) that compared the efficacy of F-TCC versus RCW, focusing on the time to ulcer healing in adult persons (18+ years) with NPFUs and type 1 or type 2 diabetes. We meta-analysed the mean differences and associated 95% CIs using an inverse variance, random-effects model. We also conducted a trial sequential analysis (TSA) to assess if the available evidence is up to the required information size for a robust conclusion. We assessed and quantified statistical heterogeneity between the included studies using the I2 statistic.ResultsOut of 102 retrieved citations, five RCTs met the eligibility criteria. Participants’ inclusion in relation to stage of ulcer was highly variable as was peripheral neuropathy complicating comparisons. F-TCC appeared to present a shorter ulcer healing time (−5.42 days, 95% CI −9.66 days to −1.17 days; I2 9.9%; 5 RCTs; 169 participants) compared with RCW. This finding was supported by the TSA.ConclusionsThere is limited evidence from RCTs to suggest that F-TCC has a shorter ulcer healing time compared with RCW among adults with diabetic NPFUs. Properly designed and conducted RCTs are still required for a stronger evidence base.

Context for Practice: Updated Guidelines for Diabetic Foot, Neuropathic Ulcers, Use of Convexity During the Postoperative Period, Pressure Injury Prevention.

Context for Practice: Updated Guidelines for Diabetic Foot, Neuropathic Ulcers, Use of Convexity During the Postoperative Period, Pressure Injury Prevention.