Clinical Research Directory

Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) will be considered a clinically important complication of diabetes mellitus that may impair sensory function and interfere with the performance of daily activities involving the hands and feet. Sensory deficits may affect tactile perception, object manipulation, foot-related functional tasks, and the ability to interact safely with the surrounding environment. The purpose of this study will be to investigate the effects of adaptive gamified sensory training combined with conventional physical therapy on sensory function, sensory integration during balance, and hand functional performance in patients with diabetic peripheral neuropathy.

Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy

This study will compare perturbation-based balance training (PBBT) with conventional balance training in patients with diabetic peripheral neuropathy to assess reactive stepping ability, dynamic balance, and functional balance. Diabetic peripheral neuropathy is a prevalent complication of type 2 diabetes, affecting nearly 43% of diabetic patients in Pakistan. As a progressive condition, it leads to peripheral sensory loss, proprioceptive deficits, and delayed neuromuscular responses, all of which compromise balance and postural control and place this population at significantly elevated risk of falls. In this study, a total of 40 adults with DPN will be randomly allocated into two groups: PBBT and CBT. Both groups will receive a total of 24 sessions with 3 supervised sessions per week for 8 weeks. The PBBT group will receive manually delivered, repeated, unexpected perturbations by a physical therapist. The CBT group will receive conventional balance training without perturbations. Outcome measures will include reactive stepping (Lean-and-Release Test), dynamic balance (Mini-BESTest), and functional balance (Berg Balance Scale). The assessment will be done at baseline, post-intervention (Week 8), and follow-up (Week 12). The study aims to determine which intervention provides superior improvement in reactive stepping and balance in patients with diabetic peripheral neuropathy.

Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implant stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.

Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy

Painful diabetic peripheral neuropathy (DPN) is a frequent and disabling complication of diabetes that commonly causes persistent foot pain, sleep impairment, and decreased quality of life. While oral medications such as duloxetine are established treatment options, many patients experience incomplete pain control or encounter dose-limiting side effects. Perineural botulinum toxin type A (BTX-A) injection has emerged as an interventional approach designed to inhibit peripheral pain signaling with targeted, prolonged local effect. The purpose of this study is to compare the efficacy and safety of a single session of ultrasound-guided perineural BTX-A injection versus standard daily oral duloxetine therapy in relieving foot pain in patients with painful diabetic peripheral neuropathy. Participants will be randomly assigned to one of two groups using a double-dummy design to preserve blinding: * Group B (Botulinum Toxin): Receives a single session of ultrasound-guided perineural botulinum toxin type A injection around the ankle nerves plus daily oral placebo tablets for 12 weeks. * Group D (Duloxetine): Receives a single session of sham subcutaneous injection plus oral duloxetine tablets daily for 12 weeks (30 mg once daily for week 1, increased to 60 mg once daily for weeks 2-12). Participants will be followed for 6 months to evaluate changes in foot pain intensity on the Visual Analogue Scale (VAS) at 1 week, 1 month, 3 months, and 6 months. The study will also assess objective peripheral nerve function through bilateral nerve conduction studies (NCS) at baseline and 6 months, alongside evaluations of neuropathic pain scores, sleep quality, quality of life, and adverse effects.

Activity Reduction vs Advice for Plantar Hotspots in Diabetes

This randomized proof-of-concept trial will evaluate whether an individualized, objectively monitored temporary reduction in walking activity can accelerate resolution of plantar thermal hotspots in adults with diabetes who are at high risk of foot ulceration. A plantar thermal hotspot is defined as a temperature difference greater than 2.2°C between corresponding sites on the two feet on two consecutive days. Participants with a confirmed eligible hotspot will be randomly assigned to either an individualized numerical daily step-count target or standard non-quantified advice to reduce walking and weight-bearing activity. Both groups will receive standard diabetic-foot preventive care, daily foot-temperature monitoring, and objective activity monitoring. The primary outcome is the time from randomization to sustained resolution of the index plantar thermal hotspot during the first 14 days. Participants will be followed for 28 days to assess hotspot recurrence, foot-related outcomes, safety, and acceptability.

Effects of Functional Magnetic Stimulation in Sensory and Motor Function in Diabethic Neuropathy

This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Feldenkrais vs. Task Oriented Gait Training on Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) causes balance problems, falls, and sensory loss in the feet. This study compares two non-drug exercise programs to see which works better. The first program is Feldenkrais exercises, which focus on movement awareness and retraining the brain. The second program is Task Oriented Gait Training, which practices specific walking tasks. Researchers will measure balance, joint position sense, touch sensation, fear of falling, and quality of life. Forty participants will be split into two groups. The study will last 12 weeks.

Walking Function in Diabetic Peripheral Neuropathy

The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief. In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

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.

Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Rehabilitation strategies targeting sensory and proprioceptive impairments are essential to improve postural control and mobility in this population. This randomized controlled trial aims to compare the effects of proprioceptive neuromuscular training and sensory re-education on balance and gait performance in patients with diabetic peripheral neuropathy. Participants diagnosed with DPN will be randomly allocated into two groups. Group A will receive sensory re-education, while Group B will undergo a structured proprioceptive training program. Both groups will also receive baseline conventional treatment. Balance and gait outcomes will be assessed using the Berg Balance Scale and the Dynamic Gait Index at baseline, mid-intervention, and post-intervention. The findings of this study may help determine the more effective rehabilitation approach for improving balance and gait in individuals with diabetic peripheral neuropathy, thereby reducing fall risk and enhancing functional independence.

Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy.

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes that can cause impairments in sensation, dexterity, and upper-limb function. Current treatment approaches mainly focus on symptom management and glycemic control, while interventions specifically targeting sensory recovery remain limited. This randomized sham-controlled trial aims to evaluate the effectiveness of a Structured Multisensory Re-education Program (SENS-UL) in improving sensory function and upper-limb sensorimotor performance in adults with DPN. Participants will be randomly assigned to either an intervention group receiving structured multisensory sensory re-education or a sham-control group receiving passive sensory exposure without active sensory retraining. The intervention will be delivered twice weekly for five weeks. Outcome measures will include sensory function, neuropathy severity, thermal and tactile sensation, vibration perception, proprioception, dexterity, and neuropathy-related quality of life. Assessments will be conducted before and after the intervention period. The study is expected to provide evidence regarding the effectiveness of multisensory sensory rehabilitation for individuals with DPN and may contribute to the development of targeted rehabilitation strategies aimed at improving sensory recovery, hand function, and quality of life.

Photobiomodulation for Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is a common complication of long-term diabetes, affecting approximately 50 percent of patients. It causes tingling, numbness, and burning pain primarily in the feet, which reduces quality of life. Photobiomodulation therapy (PBMT), also known as low-level laser therapy, is a non-invasive treatment that may improve nerve function by reducing inflammation and promoting cellular repair. This randomized controlled trial aims to evaluate the effectiveness of PBMT in improving nerve function and quality of life in patients with DPN. A total of 36 participants with type 2 diabetes and DPN will be randomly assigned to either a treatment group receiving PBMT (900 nm wavelength, 25W, 1000 Hz frequency) or a control group receiving sham laser therapy. The intervention will be applied to the dorsum and plantar surface of the foot every other day for 6 weeks. Outcomes include pain intensity measured by the Numeric Pain Rating Scale, Neuropathic pain measured by Leeds Assessment of Neuropathic symptoms and signs scale, Nerve function measured by Michigan Neuropathy Screening Instrument and quality of life measured by the NORFOLK QOL DN questionnaire, assessed at baseline and after the intervention period.

Shortwave Intervention for Diabetic Peripheral Neuropathy.

This study is a single-center, randomized, single-blind, sham-controlled clinical trial aimed at evaluating the efficacy and safety of shortwave therapy administered for five consecutive days in the treatment of diabetic peripheral neuropathy. The study plans to enroll 202 patients, who will be randomly assigned in a 1:1 ratio to either the shortwave therapy group (20 minutes daily for five consecutive days) or a sham treatment group with an identical appearance. The primary efficacy endpoint is the remission rate of the Toronto Clinical Scoring System score one month after treatment (a decrease of ≥1 point). Secondary endpoints include short-term efficacy, pain visual analog scale scores, quality of life scores, and safety indicators. The study hypothesizes that shortwave therapy can significantly improve neurological symptoms, with an expected remission rate of 65% in the treatment group and 20% in the control group, with the superiority margin set at 20%. This study will provide high-quality evidence-based medical evidence for the use of shortwave therapy in diabetic peripheral neuropathy.

Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy

The goal of this clinical trial is to learn if a single session of ultrasound-guided nerve hydrodissection can relieve symptoms of diabetic lower limb entrapment neuropathy, a condition caused by compressed nerves in the leg that leads to numbness, pain, or muscle weakness in people with diabetes. The main questions it aims to answer are whether nerve hydrodissection improves nerve function (measured by the Toronto Clinical Scoring System) one month after treatment, and whether it relieves pain and improves quality of life. Researchers will compare two groups: one will receive the actual nerve hydrodissection (injection of medicine around the compressed nerve), and the other will receive a sham procedure that involves injecting a small amount of fluid under the skin (not around the nerve). Participants will not know which group they are in, and the researchers who measure the results will also not know. Participants will have four in-person visits over about one month, complete questionnaires about their nerve symptoms, pain, and quality of life, undergo nerve ultrasound at the beginning and at follow-up visits (at 1 month after treatment), and receive either the nerve hydrodissection or the sham procedure at the second visit. All participants will continue their regular diabetes and nerve medication during the study.

Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy

To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy

Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy

this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.

Stromal Vascular Cells for the Treatment of Diabetic Peripheral Neuropathy

This is an interventional open-label study to determine the safety and clinical performance of SVF cells in the treatment of Diabetic Peripheral Neuropathy.

Effects of Glycemic Control and Clinical Parameters on Tibial Nerve Conduction Latency in Diabetic Peripheral Neuropathy

This observational cross-sectional study aims to investigate the effects of glycemic control and clinical parameters on tibial nerve conduction latency in individuals with diabetic peripheral neuropathy. Adults aged 45 to 76 years with diabetic peripheral neuropathy will be evaluated at a neurology and clinical neurophysiology clinic. Data collection will include demographic and clinical characteristics, diabetes type and duration, fasting blood glucose, and HbA1c values obtained from routine clinical records. Participants will also be assessed using the Michigan Neuropathy Screening Instrument (MNSI), including both the questionnaire and physical examination components. Nerve conduction studies will be performed using standard electromyography procedures, and tibial nerve conduction latency will be recorded. The study will examine the relationship between tibial nerve conduction latency and glycemic control parameters, neuropathy screening scores, and diabetes duration. The findings may help improve early identification and clinical evaluation of diabetic peripheral neuropathy.

Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain

The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.

Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN). The primary goals are to evaluate: * Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN * Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN The participants will be required to complete * Questionnaires * Clinical examination * 3-Dimensional gait analysis on an instrumented treadmill * Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking