Clinical Research Directory

Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy

Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS). However, the effectiveness of OS is highly dependent on the individual shoe technician's skill and experience, and OS is frequently perceived as unattractive by users. To overcome these limitations, the LEEF-shoe was developed. It eliminates the need for a fully individualized shoe technician approach by using a standardized protocol to determine the rocker settings. This may provide comparable plantar pressure relief, while potentially improving patient acceptance due to its more appealing design and simplified prescription process. Objective: The primary objective is to determine whether the LEEF-shoe differs from standard-OS in terms of plantar pressure distribution. Secondary objectives are evaluation of wearing time and user acceptance of both footwear types. Study design: This study is a randomized cross-over trial. Participants will complete pre- and post-tests for plantar pressure distribution, wearing time will be measured, and focus group sessions will assess user experience and acceptance. Study population: A total of 30 adults (≥18 years old) with diabetes mellitus and peripheral neuropathy, at increased risk for foot ulceration, will be included. Intervention: All participants will receive two pairs of OS, a standard-OS and an additional OS (e.g., the LEEF-shoe), both provided through usual care channels. At handover, plantar pressure measurements will be performed. Participants will then wear each shoe model for four weeks, one after the other, with wearing time continuously monitored. Following the 8-week period, participants return for a standard control appointment with the OS-technician, during which post-test pressure measurements are taken. Subsequently, participants are allowed to wear either shoe based on personal preference for an additional four weeks, during which wearing time continues to be recorded. The study concludes with focus group sessions to explore experiences and acceptance. Main study parameters/endpoints: The primary outcome of the study is peak plantar pressure. It will be compared between the standard-OS and LEEF-shoe during the randomization visit. The secondary outcomes are peak plantar pressures in 7 foot regions, wearing time of the OS and user experience and acceptance, assessed through semi-structured focus groups. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be screened for eligibility during their regular consultation with the prescribing physician and OS-technician. After inclusion, participants will follow standard care procedures, which include an initial shoe fitting, a midway fitting, the handover of both shoes, and two follow-up appointments. To minimize any potential risk associated with wearing the LEEF-shoe at home following the handover, it is required that the LEEF-shoe is at least equivalent to, or better than, the standard-OS in terms of function and safety. Since the LEEF-shoe is produced within the existing framework and standards of OS manufacturing, it is considered a variant of standard-OS and thus falls within the boundaries of standard care.

Long COVID-19 Cutaneous Signatures: An ARPA Funded Research Project

This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.

Effects of Ankle Block on Postoperative Analgesia in Diabetic and Non-Diabetic Patients

This prospective observational study aims to evaluate the effects of ultrasound-guided ankle block on sensory and motor block characteristics and postoperative analgesic outcomes in patients undergoing lower extremity surgery. The study will compare diabetic and non-diabetic patients and will also assess the impact of glycemic control on block onset time and postoperative analgesic consumption. Ankle block is commonly used in patients undergoing foot and ankle surgery, particularly in those with diabetes, peripheral neuropathy, or vascular disease, when general or neuraxial anesthesia may not be suitable. Previous studies suggest that diabetic neuropathy and impaired glycemic control may influence the onset and duration of peripheral nerve blocks. Adult patients scheduled for lower extremity surgery under ankle block will be included. All procedures will be performed as part of routine clinical care, and no additional interventions will be applied for research purposes. Sensory and motor block onset times, postoperative pain scores, opioid consumption within the first 24 hours, and patient and surgeon satisfaction will be recorded. The results of this study are expected to provide clinically relevant information regarding the effects of diabetes and glycemic control on ankle block characteristics and postoperative analgesia.

Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.

Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes

Diabetes mellitus is a chronic disease that can cause many complications, one of the most common being diabetic neuropathy. This condition occurs due to long-term high blood sugar levels that damage the nerves. Symptoms include tingling, burning, pain, and loss of sensation in the feet. If not prevented, neuropathy can progress to diabetic foot ulcers and even lead to amputation. This study aims to evaluate whether Golden Rice Cookies enriched with Red Betel Leaf (Piper crocatum) can help prevent diabetic neuropathy in patients with diabetes. Golden rice is a type of rice that contains beta-carotene (provitamin A) and high fiber, which help maintain stable blood sugar levels and reduce oxidative stress. Meanwhile, red betel leaf contains flavonoids, polyphenols, and alkaloids with antioxidant, anti-inflammatory, and hypoglycemic properties that may protect nerves from damage. Cookies were chosen as the intervention form because they are practical, easy to consume, and widely accepted by patients. In this study, patients will be divided into two groups: an intervention group receiving golden rice cookies with red betel leaf extract, and a control group receiving golden rice cookies without the extract. Changes in neuropathy symptoms will be assessed using the Neuropathy Symptom Score (NSS) before and after the intervention. The expected outcome of this research is to provide scientific evidence that the combination of golden rice and red betel leaf in the form of cookies can serve as an effective, safe, and acceptable functional food to help prevent diabetic neuropathy. This nutritional intervention may support comprehensive diabetes management and improve patients' quality of life.

Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.

Vitamin D, Nerve Growth Factor and Nerve Conduction Studies in Adult Male Type 2 Diabetic Neuropathy Patients

study the relationship of vitamin d with nerve growth factor level and nerve conduction studies in adult male type 2 diabetic neuropathy patients

Additional Effects of Neural Mobilization on Pain, Balance and Quality of Life in Diabetic Neuropathy

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, affecting up to 50% of patients and causing pain, numbness, and balance impairments, which increase the risk of falls, ulcers, and reduced quality of life. Current treatments mainly manage symptoms, highlighting the need for adjunctive approaches. This randomized controlled trial will evaluate the additional effects of Neural Mobilization (NM) on pain, balance, and quality of life in DPN. Thirty-two patients with type 2 diabetes and DPN will be recruited at Fauji Foundation Hospital and screened using the Michigan Neuropathy Screening Instrument (MNSI). Participants will be randomized into two groups: (1) NM plus Balance Training with standard care and (2) Balance Training alone, each for six weeks (two 30-minute sessions/week). Pain will be assessed using the Numeric Pain Rating Scale (NPRS), balance using the Berg Balance Scale, and quality of life using the Norfolk QOL-DN questionnaire. Outcome measures will be recorded at baseline and post-intervention. Ethical approval will be obtained from FUMC ERC, and data will be analyzed using SPSS v.22.

Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy

* Randomized controlled trial evaluating active and passive neurodynamic techniques for diabetic neuropathy. * Sample size: 60 patients (30 per group), aged 40 to 65 years, diagnosed with diabetes mellitus. * Exclusion criteria: Systemic diseases, pregnancy, fractures, foot ulceration, amputation, osteoarthritis. * Study will be conducted at physiotherapy OPDs of Dow Ojha Hospital, DIPMR,NIDE and Baqai Institute of Diabetology and Endocrinology. * Participants randomly assigned into two groups using a computer-generated randomization sheet. Group A: Active neurodynamics (neural flossing) - patient-controlled nerve gliding movements. Group B: Passive neurodynamics (tensioners) - therapist-applied nerve stretches. * Standard treatment includes gait training, lower limb strengthening exercised, and stationary bike sessions. * Treatment: 12 sessions over 4 weeks (3 sessions per week, 30 minutes each session). * Assessments will be done at baseline and post-intervention by a blinded physical therapist. * Outcome measures: DN-4 (pain), MMT (muscle strength), Goniometry (ROM), LLTT (nerve mobility). * Data were analyzed using SPSS Version 27. A one-way ANOVA was performed to compare the results before and after the intervention. * Study duration: 9 months, including approval, pilot study, data collection, and final presentation. * Study aims to determine the most effective neurodynamic technique for pain relief, mobility, and muscle strength. * Findings will guide better rehabilitation strategies for improved patient outcomes and quality of life.

GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes

The goal of this randomized controlled trial is to learn if GlucoBites functional cookies containing Gynura procumbens can help improve blood sugar control and lower the risk of diabetic foot ulcers in adults with type 2 diabetes. The main questions are: * Do GlucoBites cookies lower fasting blood glucose and HbA1c? * Do GlucoBites cookies improve insulin resistance and vascular health? * Can GlucoBites reduce early signs that may lead to diabetic foot ulcers? Researchers will compare: * Intervention group: participants will eat 4 GlucoBites cookies every day for 12 weeks. * Control group: participants will continue standard diabetes care without GlucoBites. Participants will: * Visit the community health center for blood tests and foot health checks. * Be monitored for blood sugar, insulin resistance, lipid profile, and vascular function. * Be assessed for early risk of diabetic foot ulcer development. This study will help determine if a functional food innovation can support diabetes care and prevent complications.

Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy

The aim of the current study is to measure the effect of melatonin as adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in type 2 diabetic patients with diabetic peripheral neuropathy.

The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients

The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass

Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

Distal symmetric polyneuropathy, also known as diabetic neuropathy, is the most common neurological complication of diabetes and a main cause of morbidity. The condition leads to gradual loss of function of the longest nerve fibers that limits function and decreases quality of life. Symptoms present distally and symmetrically in toes and feet. Symptoms of the neurologic disability include sensory loss, risk of foot ulcers and limb amputations and pain. The condition is not generally considered reversible, and condition management aims to slow progression and prevent complications. According to estimates from the International Diabetes Federation, diabetic neuropathy affected approximately 425 million people in 2017, with projections indicating a rise to 628 million by 2045. Despite the high prevalence of this condition, it is commonly misdiagnosed and has limited treatment options. There are multiple phenotypes of diabetic neuropathy, with the most common form being distal symmetric sensorimotor polyneuropathy, which is what we will be focusing on in this study. The proposed study seeks to evaluate the effectiveness of a non-compressive therapeutic socks throughout a 12-week course of rehabilitation for managing distal symmetric polyneuropathy. Outcome measures will be collected at standard intervals and compared with pre-treatment measures to evaluate effectiveness of treatment.

Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy

The study is planned to be conducted in a mixed research design with quantitative and qualitative types. The quantitative phase of the study was planned as a single-blind, randomized controlled study with Reiki group, Sham Reiki group and control group designs in order to examine the effect of second-level (remote application) Reiki applied to patients with diabetic neuropathy for 20 minutes a day for four days on pain intensity, neuropathic pain intensity (DN4 Questionnaire) total scores and sleep quality. The qualitative study will be conducted with 4 people from the Reiki and Sham Reiki groups, a total of 8 patients, one week after the application, using the individual in-depth interview method and a semi-structured questionnaire.