Diabetic Neuropathy

11

Review clinical trials related to Diabetic Neuropathy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

tSCS and AR Training on QoL and Physical Activity in Diabetic Neuropathy Patients

Existing evidence of tSCS emphasizes pain relief and overlooks other functional parameters such as sensory enhancement, lower limb flexibility, and sustained improvements in physical activity and QoL. Combined effects of tSCS and AR training on lower limb flexibility, vibration sense, QoL, and physical activity in patients with diabetic neuropathy. This dual approach has the potential to deliver a comprehensive strategy for managing DPN, which is low-cost, safe, and a more accessible solution for diabetic patients in Pakistan and around the world.

Participants needed: 36
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Riphah International UniversityUpdated: Jun 2, 2026
Eligibility criteria

More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4) [+1]

Cognitively compromised (MOCA score ≤ 26/30) [+3]

Status: Not yet recruiting

Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients

The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy. This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software. A consecutive sampling technique will be implemented. Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method. Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability. In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment. Written as well as verbal informed consent will be obtained prior to participation. The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions. The primary outcomes will focus on balance performance and fall risk. These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test. Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument. Statistical analysis will be performed using SPSS version 23.

Participants needed: 42
Trial details
Age: 40-75Biological sex: AllType: InterventionalSponsor: University of FaisalabadUpdated: May 20, 2026Locations: 1
Eligibility criteria

Individuals with a confirmed clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5%... [+8]

Patients with a confirmed diagnosis of benign paroxysmal positional vertigo (BPP... [+7]

Status: Recruiting

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.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Medical Center GroningenUpdated: Mar 23, 2026Locations: 1
Eligibility criteria

Aged 18 years or older [+4]

Severe foot deformities [+4]

Status: Not yet recruiting

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.

Participants needed: 46
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fatih Sultan Mehmet Training and Research HospitalUpdated: Feb 11, 2026Locations: 1
Eligibility criteria

Adults aged 18 years and older. [+3]

Refusal or inability to provide informed consent. [+9]

Status: Not yet recruiting

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

Participants needed: 57
Trial details
Age: 40-60Biological sex: MaleType: ObservationalSponsor: Aswan UniversityUpdated: Nov 19, 2025Locations: 2
Eligibility criteria

Adult male patients 40 -65 years' old who have type 2 diabetes mellitus on oral...

Cardiac patients. [+9]

Status: Recruiting

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.

Participants needed: 32
Trial details
Age: 50-75Biological sex: AllType: InterventionalSponsor: Foundation University IslamabadUpdated: Oct 7, 2025Locations: 1
Eligibility criteria

Both genders. [+5]

Patients with Neurological Disorders like Stroke, multiple sclerosis, Parkinson'... [+4]

Status: Not yet recruiting

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.

Participants needed: 126
Trial details
Age: 20-70Biological sex: AllType: InterventionalSponsor: Andina SetyawatiUpdated: Sep 3, 2025Locations: 1
Eligibility criteria

Adults aged 20-70 years. [+5]

Current use of herbal supplements or functional foods containing Gynura procumbe... [+5]

Status: Recruiting

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.

Participants needed: 60
Trial details
Phase: Phase 2Age: 40-75Biological sex: AllType: InterventionalSponsor: Ain Shams UniversityUpdated: Aug 6, 2025Locations: 1
Eligibility criteria

Patients aged 40-75 years diagnosed with type 2 DM. [+3]

Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thy... [+8]

Status: Recruiting

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

Participants needed: 60
Trial details
Age: 45+Biological sex: AllType: ObservationalSponsor: Ain Shams UniversityUpdated: May 6, 2025Locations: 2
Eligibility criteria

The study group consisted of patients diagnosed with Type 2 diabetes mellitus ag...

Type 1 DM, gestational diabetes mellitus [+4]

Status: Recruiting

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.

Participants needed: 80
Trial details
Age: 18-79Biological sex: AllType: InterventionalSponsor: Endocrine Research SolutionsUpdated: Feb 25, 2025Locations: 1
Eligibility criteria

Patients diagnosed with mild to moderate Diabetic Neuropathy with a score betwee... [+4]

Patient has a history of neurodegenerative conditions, including multiple sclero... [+13]

Status: Recruiting

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.

Participants needed: 60
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: TC Erciyes UniversityUpdated: Feb 14, 2025Locations: 1
Eligibility criteria

Over 18 years of age [+8]

Receiving a different illness and treatment during the therapy process [+5]