Publications by authors named "Manish Bharara"

Purpose: The recent SENZA-PDN study showed that high-frequency (10kHz) spinal cord stimulation (SCS) provided significant, durable pain relief for individuals with painful diabetic neuropathy (PDN), along with secondary benefits, including improved sleep quality and HRQoL. Given that metabolic factors and chronic neuropathic pain are related, we evaluated potential secondary effects of 10kHz SCS on hemoglobin A1c (HbA1c) and weight in SENZA-PDN participants with type 2 diabetes (T2D).

Patients And Methods: This analysis included 144 participants with T2D and lower limb pain due to PDN who received 10kHz SCS during the SENZA-PDN study.

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Background: Painful diabetic neuropathy (PDN) can result in the loss of protective sensation, in which people are at twice the likelihood of foot ulceration and three times the risk of lower extremity amputation. Here, we evaluated the long-term effects of high-frequency (10 kHz) paresthesia-independent spinal cord stimulation (SCS) on protective sensation in the feet and the associated risk of foot ulceration for individuals with PDN.

Methods: The SENZA-PDN clinical study was a randomized, controlled trial in which 216 participants with PDN were randomized to receive either conventional medical management (CMM) alone or 10 kHz SCS plus CMM, with optional treatment crossover after 6 months.

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Objective: The objective of this study was to evaluate the 24-month durability of pain relief, function, quality of life, and safety outcomes for patients with nonsurgical refractory back pain (NSRBP) treated with high-frequency spinal cord stimulation (SCS) within a large, national, multicenter randomized controlled trial (RCT).

Methods: Following the completion of an RCT comparing high-frequency SCS plus CMM with CMM alone for the treatment of NSRBP, patients gave additional consent for a follow-up extension to 24 months. Presented is the cohort analysis of all patients treated with high-frequency SCS following the optional crossover at 6 months.

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Introduction: Chronic pain is a common clinical condition and is frequently treated with a variety of medications, but pharmacotherapy is oftentimes not the optimal long-term treatment option. Safe and effective long-term pain relief for trunk and limb pain is available using high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS), which is delivered using a rechargeable implantable pulse generator (IPG). Although rechargeable devices have been shown to reduce patient risk and overall cost by eliminating the need for periodic surgeries to replace depleted non-rechargeable IPGs, there is little published evidence that rechargeable technology is practical and convenient for patients, especially in the context of 10 kHz SCS.

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Background: Diabetes is one of the most prevalent chronic health conditions and diabetic neuropathy one of its most prevalent and debilitating complications. While there are treatments available for painful diabetic peripheral neuropathy (pDPN), their effectiveness is limited.

Method: This retrospective, multi-center, real-world review assessed pain relief and functional improvements for consecutive patients with diabetic neuropathy aged ≥18 years of age who were permanently implanted with a high-frequency (10 kHz) spinal cord stimulation (SCS) device.

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Objective: The objective was to report patterns of physical activity and their relationship to wound healing success in patients with diabetic foot ulcers protected with removable or irremovable offloading devices.

Methods: Forty-nine people with diabetic foot ulcers were randomized to wear either a removable cast walker (RCW) or an irremovable instant total contact cast (iTCC). Primary outcome measures included change in wound size, physical activities including position (ie, sitting, standing, lying) and locomotion (speed, steps, etc).

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The high mortality and disability of diabetic nonhealing skin ulcers create an urgent need for the development of more efficacious strategies targeting diabetic wound healing. In the current study, using human clinical specimens, we show that perilesional skin tissues from patients with diabetes are under more severe oxidative stress and display higher activation of the nuclear factor-E2-related factor 2 (NRF2)-mediated antioxidant response than perilesional skin tissues from normoglycemic patients. In a streptozotocin-induced diabetes mouse model, Nrf2(-/-) mice have delayed wound closure rates compared with Nrf2(+/+) mice, which is, at least partially, due to greater oxidative DNA damage, low transforming growth factor-β1 (TGF-β1) and high matrix metalloproteinase 9 (MMP9) expression, and increased apoptosis.

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Background: Individuals with diabetic peripheral neuropathy (DPN) have deficits in sensory and motor skills leading to inadequate proprioceptive feedback, impaired postural balance and higher fall risk.

Objective: This study investigated the effect of sensor-based interactive balance training on postural stability and daily physical activity in older adults with diabetes.

Methods: Thirty-nine older adults with DPN were enrolled (age 63.

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Background: Individuals with diabetic peripheral neuropathy frequently experience concomitant impaired proprioception and postural instability. Conventional exercise training has been demonstrated to be effective in improving balance but does not incorporate visual feedback targeting joint perception, which is an integral mechanism that helps compensate for impaired proprioception in diabetic peripheral neuropathy.

Methods: This prospective cohort study recruited 29 participants (mean ± SD: age, 57 ± 10 years; body mass index [calculated as weight in kilograms divided by height in meters squared], 26.

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Background: Gait-related fall risk is the leading cause of mortality among patients with diabetes, especially those older than 65 years. Deterioration in balance and loss of protective sensation in lower extremities contribute significantly to fall risk in patients with diabetic peripheral neuropathy (DPN). This study aimed to explore the impact of neuropathy and foot ulcer on gait.

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Background: While endovascular (ENDO) therapy has increasingly become the initial intervention of choice to treat lower extremity peripheral arterial disease, reported outcomes for ENDO in patients with critical limb ischemia (CLI) and diabetes have been reported to be inferior compared to open bypass surgery (OPEN). Objective data assessing the hemodynamic success of ENDO compared to the established benchmark of OPEN are sparse. We therefore evaluated and compared early hemodynamic outcomes of ENDO and OPEN in patients with diabetes with CLI at a single academic center.

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Objective: There is a dearth of long-term data regarding patient and limb survival in patients with diabetic foot ulcers (DFUs). The purpose of our study was therefore to prospectively investigate the limb and person survival of DFU patients during a follow-up period of more than 10 years.

Research Design And Methods: Two hundred forty-seven patients with DFUs and without previous major amputation consecutively presenting to a single diabetes center between June 1998 and December 1999 were included in this study and followed up until May 2011.

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Objective: To evaluate the accuracy and effective service life of commercially available Semmes-Weinstein monofilaments with repetitive loading.

Methods: We obtained 6 brands of Semmes-Weinstein monofilaments (SWM) from commercial vendors identified from the Internet and the federal registry. Five monofilaments of each brand were subjected to repeat loading cycles, allowed to rest over night and loaded again the next day.

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Objective: This study aimed to quantify the impact of an integrated diabetic foot surgical service on outcomes and changes in surgical volume and focus.

Methods: We abstracted registry data from 48 consecutive months at a single institution, evaluating all patients with diabetic foot complications requiring surgery or vascular intervention, and compared outcomes in the 24 months before and after integrating podiatric surgery with vascular surgical limb-salvage service.

Results: The service performed 2923 operations; 790 (27.

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Preventing amputations in persons with lower extremity complications of diabetes is a complex endeavor, particularly in those with concomitant ischemia and tissue loss. Fluorescence angiography (Novadaq SPY system) may provide a tool for objective evaluations of tissue viability in the diabetic foot, which is an important indicator of the ability of the diabetic ulcer to heal adequately. The SPY system uses a low-power laser coupled with a charge-coupled device camera and indocyanine green (ICG) to sequence perfusion at the surface of the skin.

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Adventitious bursae typically develop in areas of chronic frictional irritation, usually under bony prominences. Although adventitious bursae are generally well understood, there is a paucity of data on effects of bursae underlying chronic wounds in neuropathic patients. This manuscripts reviews 4 clinical cases, each with a neuropathic patient with adventitious bursae underlying chronic nonhealing wound and strategies for treatment.

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The incidence of diabetic foot complications, most notably wounds, is increasing worldwide. Most people who present for care of a foot wound will become infected. Globally, this results in one major amputation every 30 seconds with over 2500 limbs lost per day.

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Diabetic foot complications are increasing in prevalence worldwide. Care and attention to these complications have improved greatly. Many advanced therapies are now being investigated or taken through final stages of clinical studies worldwide.

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With the advent of several innovative wound care management tools, the choice of products and treatment modalities available to clinicians continues to expand. High costs associated with wound care, especially diabetic foot wounds, make it important for clinician scientists to research alternative therapies and optimally incorporate them into wound care protocols appropriately. This article reviews using sugar as a treatment option in diabetic foot care and provides a guide to its appropriate use in healing foot ulcers.

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Autologous platelet-rich plasma (PRP) may enhance wound healing through the formation of a platelet plug that provides both hemostasis and the secretion of biologically active proteins, including growth factors such as platelet-derived growth factor, transforming growth factor (TGF)-β, TGF-β2, and epidermal growth factor. The release of these growth factors into the wound may create an environment more conducive to tissue repair and could accelerate postoperative wound healing. To our knowledge, there are no reports of combining the use of PRP with curative diabetic foot surgery.

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Diabetic foot disease frequently leads to substantial long-term complications, imposing a huge socioeconomic burden on available resources and health-care systems. Peripheral neuropathy, repetitive trauma, and peripheral vascular disease are common underlying pathways that lead to skin breakdown, often setting the stage for limb-threatening infection. Individuals with diabetes presenting with foot infection warrant optimal surgical management to affect limb salvage and prevent amputation; aggressive short-term and meticulous long-term care plans are required.

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Diabetic foot disease frequently leads to substantial long-term complications, imposing a huge socioeconomic burden on available resources and health care systems. Peripheral neuropathy, repetitive trauma, and peripheral vascular disease are common underlying pathways that lead to skin breakdown, often setting the stage for limb-threatening infection. Individuals with diabetes presenting with foot infection warrant optimal surgical management to effect limb salvage and prevent amputation; aggressive short-term and meticulous long-term care plans are required.

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Diabetic foot ulcers are the most common lower extremity complications of diabetes. Peripheral neuropathy and peripheral vascular disease are the underlying risk factors for diabetic foot ulcers, subsequently leading to infections and requiring antimicrobial therapy for the management of the disease. Each risk factor is a target for clinical intervention, with the intent to delay or prevent disease progression to amputation.

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Negative pressure wound therapy (NPWT) is frequently employed in the treatment of complex wounds. A variety of wound chemotherapeutic agents such as insulin, which acts as a growth factor, may prove helpful in treatment as well. We present a case report in which insulin was used as a chemotherapeutic agent in continuous-instillation NPWT.

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