Clinical trials: Painful Diabetic Neuropathy
Painful Diabetic Neuropathy
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to…
- Trial name
- NCT05476276
- Testing
- ISA specific
- Where
- 23 sites in United States
- Volunteers
- 127 people
- Sponsor
- James P. Rathmell, MD
Painful Diabetic Neuropathy
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.
- Trial name
- EN21-01 (NCT05480228)
- Testing
- NRD135SE.1
- Where
- 26 sites in United States
- Volunteers
- 127 people
- Sponsor
- James P. Rathmell, MD
Diabetic Neuropathy, Painful
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.
- Trial name
- NCT05670600
- Testing
- foot and ankle exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Gazi University
Neuropathic Pain Management, Diabetic Neuropathies, Painful
Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.
This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.
- Conditions
- Neuropathic Pain Management, Diabetic Neuropathies, Painful, Palmitoylethanolamide
- Trial name
- NCT07377409
- Testing
- Cronilief™ (300 mg)
- Volunteers
- 70 people
- Sponsor
- Azienda di Servizi alla Persona di Pavia
Painful Diabetic Peripheral Neuropathy
Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
- Trial name
- NCT03172598
- Testing
- MT-8554 low dose, MT-8554 middle dose, MT-8554 high dose
- Where
- 3 sites in Germany, Hungary and 1 more
- Volunteers
- 61 people
- Sponsor
- Tanabe Pharma Corporation
Painful Diabetic Peripheral Neuropathy
Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of MT-8554, compared to placebo, in subjects with painful diabetic peripheral neuropathy.
- Trial name
- NCT05123196
- Testing
- MT-8554
- Where
- 33 sites in Japan
- Volunteers
- 156 people
- Sponsor
- Tanabe Pharma Corporation
Painful Diabetic Peripheral Neuropathy (PDPN)
Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy
A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy…
- Trial name
- ENFORCE (NCT06715462)
- Testing
- N0750, Cymbalta®, Lyrica®
- Where
- Brazil
- Sponsor
- Eurofarma Laboratorios S.A.
Diabetic Neuropathy, Painful
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs.
- Trial name
- PINBOT (NCT05623111)
- Testing
- Incobotulinumtoxin-A 100 UNIT Injection, Saline
- Where
- Denmark
- Volunteers
- 80 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Painful Diabetic Neuropathy
Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation
Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN).
- Trial name
- HOME-EVNS (NCT06524284)
- Testing
- Releaf
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Neurecon BV
Painful Diabetic Neuropathy
Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial
A double-blind, randomized, placebo-controlled, single-center, 12-month phase 2 study designed to assess the safety and efficacy of VM202 as a replacement for opioid analgesics in opioid-tolerant subjects with painful diabetic…
- Trial name
- NCT04087941
- Testing
- VM-202
- Where
- United States
- Sponsor
- Brigham and Women's Hospital
Painful Diabetic Neuropathy
BurstDR Stimulation for Painful Diabetic Neuropathy
This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.
- Trial name
- NCT05985291
- Testing
- SCS in combination with CMM
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Wake Forest University Health Sciences
Peripheral Arterial Disease, Painful Diabetic Neuropathy
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition.
- Conditions
- Peripheral Arterial Disease, Painful Diabetic Neuropathy, Diabetes Mellitus, Type 2, Chronic Pain
- Trial name
- NCT06480786
- Testing
- Spinal cord stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Nebraska
Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful
Phase 3 Gene Therapy for Painful Diabetic Neuropathy
The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy.
- Trial name
- NCT02427464
- Testing
- Engensis (VM202)
- Where
- 25 sites in United States
- Volunteers
- 507 people
- Sponsor
- Helixmith Co., Ltd.
Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy.
- Trial name
- NCT04055090
- Testing
- Long-Term Follow-Up of Patients who Received Engensis (VM202)
- Where
- 14 sites in United States
- Volunteers
- 101 people
- Sponsor
- Helixmith Co., Ltd.
Diabetic Neuropathy, Painful
Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo…
- Trial name
- REGAiN-1A (NCT04469270)
- Testing
- Engensis
- Where
- 16 sites in United States
- Volunteers
- 162 people
- Sponsor
- Helixmith Co., Ltd.
Diabete Type 2, Neuropathy, Painful
Combined Circulatory and Dietary Interventions for Neuropathy
The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy.
- Trial name
- CDIN (NCT07213843)
- Testing
- INF® Therapy, NVIf
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Loma Linda University
Painful Diabetic Peripheral Neuropathy
Gene Therapy for Painful Diabetic Neuropathy
The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic…
- Trial name
- NCT01002235
- Testing
- VM202
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Painful Diabetic Neuropathies
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
- Trial name
- NCT01475786
- Testing
- Low Dose: 16 mg Engensis (VM202), High Dose: 32 mg Engensis (VM202)
- Where
- 17 sites in United States, South Korea
- Volunteers
- 104 people
- Sponsor
- Helixmith Co., Ltd.
Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)
Thai PainPREDICT Validation Study
Painful diabetic neuropathy (PDN) is one of the most common and disabling complications of diabetes mellitus, substantially affecting quality of life, daily functioning, and health system burden.
- Conditions
- Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation), Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM)
- Trial name
- PainPREDICT-Th (NCT07195045)
- Testing
- Thai PainPREDICT Questionnaire and Mobile Application
- Where
- Thailand
- Volunteers
- 277 people
- Sponsor
- Chulalongkorn University
Chronic Pain, Acute Pain
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary…
- Conditions
- Chronic Pain, Acute Pain, Post Operative Pain, Fibromyalgia, Primary
- Trial name
- NCT05754190
- Testing
- SOMA pain manager smartphone application
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Brown University