31 completed, 12 unknown, 5 terminated, 4 recruiting. 28 Phase 2, 15 Not applicable, 12 Phase 3, 2 Phase 1.
Follow Painful Diabetic Neuropathy: new trials by email Literature Review of Painful Diabetic Neuropathy trials Research Report on Painful Diabetic Neuropathy
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy Botulinum Toxin Type A, Duloxetine, Oral Placebo Tablet - Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy | Phase 2 | Not yet recruiting | Assiut University | 56 | 2026-11-01 | 2026-10-20 |
| Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy Capsaicin 8% - Peripheral Diabetic Neuropathy, Painful Diabetic Neuropathy | Active not recruiting | Averitas Pharma, Inc. | 144 | 2025-03-14 | 2026-07-13 | |
| SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease Spinal cord stimulation, Sham stimulation - Peripheral Arterial Disease, Painful Diabetic Neuropathy | Not applicable | Recruiting | University of Nebraska | 15 | 2024-12-18 | 2025-10-22 |
| Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation Releaf - Painful Diabetic Neuropathy | Not applicable | Completed | Neurecon BV | 40 | 2024-07-22 | 2025-12-09 |
| A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy pregabalin sustained-release tablets, Placebo - Painful Diabetic Neuropathy | Phase 3 | Unknown | CSPC Ouyi Pharmaceutical Co., Ltd. | 358 | 2024-05-15 | 2024-04-30 |
| Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial NeuOst, Control Intervention, Usual Care - Painful Diabetic Neuropathy | Not applicable | Unknown | University College of Osteopathy | 36 | 2024-04-30 | 2025-02-27 |
| Treatment for Painful Diabetic Neuropathy Active Controlled Transcranial Magnetic Stimulation (cTMS), Sham Controlled Transcranial Magnetic Stimulation (cTMS) - Painful Diabetic Neuropathy | Not applicable | Completed | McMaster University | 20 | 2023-10-01 | 2026-06-04 |
| BurstDR Stimulation for Painful Diabetic Neuropathy SCS in combination with CMM - Painful Diabetic Neuropathy | Terminated | Wake Forest University Health Sciences | 6 | 2023-07-03 | 2025-11-06 | |
| Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA SOMA pain manager smartphone application - Chronic Pain, Acute Pain | Recruiting | Brown University | 800 | 2023-06-20 | 2025-09-19 | |
| Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy 10 kHz SCS, CMM alone - Painful Diabetic Neuropathy | Not applicable | Active not recruiting | Nevro Corp | 143 | 2023-04-24 | 2026-06-29 |
| Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study Clinical Evaluation/Questionnaires, Nerve Conduction Study, Small fiber electrodiagnostic tests - Small Fiber Neuropathy, Diabetic Neuropathies | Completed | Tanta University | 45 | 2023-01-01 | 2024-04-10 | |
| Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management Axon Therapy and CMM, Sham and CMM - Neuralgia, Neuropathic Pain | Not applicable | Completed | NeuraLace Medical, Inc. | 93 | 2022-12-15 | 2024-07-11 |
| EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy ISA specific - Painful Diabetic Neuropathy | Phase 2 | Completed | James P. Rathmell, MD | 127 | 2022-09-21 | 2026-03-19 |
| EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA NRD135SE.1, Placebo - Painful Diabetic Neuropathy | Phase 2 | Completed | James P. Rathmell, MD | 127 | 2022-09-21 | 2026-03-19 |
| The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy Low-Intensity Focused Ultrasound (LIFU), Sham Low-Intensity Focused Ultrasound - Painful Diabetic Neuropathy | Not applicable | Unknown | Chongqing Medical University | 100 | 2022-07-07 | 2022-11-22 |
| Microvascular Dysfunction in Diabetic Peripheral Neuropathy This is a non-interventional study - Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy | Unknown | University of Plymouth | 72 | 2021-11-18 | 2021-11-11 | |
| Vitamin D and Painful Diabetic Neuropathy Cholecalciferol - Painful Diabetic Neuropathy | Not applicable | Unknown | Baqai Institute of Diabetology and Endocrinology | 216 | 2021-10-29 | 2022-07-21 |
| Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN Oral dose CNTX-6016 or oral dose Placebo - Painful Diabetic Neuropathy | Phase 1 | Completed | Centrexion Therapeutics | 46 | 2021-04-14 | 2025-07-28 |
| Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy Naltrexone, Placebo - Painful Diabetic Neuropathy | Phase 2 | Recruiting | Dartmouth-Hitchcock Medical Center | 35 | 2020-12-22 | 2026-05-06 |
| A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution, Placebo: WST-057 4mL topical solution - Painful Diabetic Neuropathy, Diabetes Mellitus | Phase 2 | Completed | WinSanTor, Inc | 58 | 2020-11-20 | 2023-10-18 |
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Diabetic Neuropathies (58) · Neuralgia (10) · Diabetes Mellitus (8) · Pain (8) · Chronic Pain (3) · Diabetes Mellitus, Type 2 (2) · Peripheral Nervous System Diseases (2) · Acute Pain (1) · Agnosia (1) · Anxiety Disorders (1) · Arthritis (1) · Cystitis, Interstitial (1) · Failed Back Surgery Syndrome (1) · Fibromyalgia (1) · Irritable Bowel Syndrome (1)
Diabetes Complications (58) · Endocrine System Diseases (58) · Nervous System Diseases (58) · Neuromuscular Diseases (58) · Peripheral Nervous System Diseases (56) · Diabetes Mellitus (50) · Neurologic Manifestations (18) · Pathological Conditions, Signs and Symptoms (18) · Signs and Symptoms (18) · Glucose Metabolism Disorders (10) · Metabolic Diseases (10) · Nutritional and Metabolic Diseases (10) · Pain (10) · Mental Disorders (2) · Arterial Occlusive Diseases (1)
Lacosamide (5) · 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- (3) · Standard of Care (3) · Carubicin (2) · Trazodone (2) · eslicarbazepine acetate (2) · Acceptance and Commitment Therapy (1) · Botulinum Toxins, Type A (1) · Capsaicin (1) · Cholecalciferol (1) · Duloxetine Hydrochloride (1) · EMA400 (1) · Gabapentin (1) · Naltrexone (1) · Nerve Conduction Studies (1)
UCB Pharma (5) · BioDelivery Sciences International (3) · Duta Wacana Christian University (3) · Aziende Chimiche Riunite Angelini Francesco S.p.A (2) · Bial - Portela C S.A. (2) · Helixmith Co., Ltd. (2) · James P. Rathmell, MD (2) · Nevro Corp (2) · WinSanTor, Inc (2) · Arcion Therapeutics Inc (1) · Assiut University (1) · AstraZeneca (1) · Averitas Pharma, Inc. (1) · Baqai Institute of Diabetology and Endocrinology (1) · Brigham and Women's Hospital (1)
United States (25) · United Kingdom (7) · Germany (5) · Poland (5) · Hungary (4) · Canada (3) · Czechia (3) · Denmark (3) · France (3) · Indonesia (3) · Austria (2) · Belgium (2) · Bulgaria (2) · China (2) · Egypt (2)
Aziz Shaibani, MD (3) · Angela Hansen (2) · Jessica Robinson-Papp, MD (2) · Rizaldy T Pinzon, MD, MSc, PhD (2) · Abdul Basit, Director (1) · Ben Imholz, PhD, MD (1) · Bruce M Vrooman, MD (1) · Calvin Howorth, BSc (Hons) (1) · Charlotte Geelen, MD (1) · Christine N. Sang, MD, MPH (1) · Chuthamanee Suthisisang, PhD. (1) · David Caraway, MD (1) · David Hohenschurz-Schmidt, PhD (1)
PMID 35587172, PMID 15834546, PMID 17237664, PMID 18403219, PMID 18619874, PMID 22683276, PMID 29588972, PMID 30506341, PMID 31941531, PMID 32936427, PMID 33465273, PMID 33675631, PMID 33791018, PMID 33818600, PMID 34844993, PMID 34854473, PMID 34984028, PMID 35770993, PMID 35814185, PMID 37536514, PMID 37833046, PMID 38193426, PMID 38914876, PMID 39308991, PMID 40304652, PMID 40495635, PMID 41309477, PMID 41352124
2004 (2), 2016 (2), 2018 (2), 2005 (1), OT2NS122680-01 (1), R44DK104512 (1), U24NS113850 (1)