Clinical trials: Diabetic Neuropathies
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
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.
Diabetic Foot, Diabetic Foot Ulcer
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- Trial name
- NCT06003530
- Testing
- hOMSC200
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Cytora Ltd.
Diabetic Foot Ulcer (DFU)
A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers
The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers.
- Trial name
- AIM-DFU (NCT07783087)
- Testing
- VES-0-D wound gel, Standard of Care (Investigator Choice)
- Where
- 8 sites in Belgium
- Volunteers
- 64 people
- Sponsor
- Flen Health
Diabetic Foot Ulcer
Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus…
- Trial name
- NCT01693133
- Testing
- Standard of Care: Moist Wound Therapy and Offloading, EpiFix plus Standard of Care
- Where
- 20 sites in United States
- Volunteers
- 132 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU).
- Trial name
- NCT01113515
- Testing
- Esmolol hydrochloride
- Where
- 5 sites in United States, India and 1 more
- Volunteers
- 44 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R).
- Trial name
- NCT01181453
- Testing
- Dermagraft, Comparator
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Organogenesis
Diabetic Neuropathy, Painful
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to…
- Trial name
- NCT00385671
- Testing
- duloxetine hydrochloride, pregabalin, gabapentin
- Where
- 9 sites in United States, Germany
- Volunteers
- 407 people
- Sponsor
- Eli Lilly and Company
Foot Ulcer, Diabetic
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without…
- Trial name
- NCT01270633
- Testing
- PriMatrix, Standard of Care
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Integra LifeSciences Corporation
Diabetes Mellitus Foot Ulcer
Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions.
- Trial name
- NCT05604352
- Testing
- DiaSole
- Volunteers
- 30 people
- Sponsor
- Kaydiar Ltd
Diabetic Neuropathies
Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
The purpose of this study is to determine the: Primary end point change of Total symptom score Secondary end point neurological test
- Trial name
- NCT01261143
- Testing
- BK-C-0701
- Where
- South Korea
- Volunteers
- 164 people
- Sponsor
- Bukwang Pharmaceutical
Diabetic Foot
BE Study of Metformin GSK 850mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 198/11 (NCT01710540)
- Testing
- Metformin GSK 850mg, Gluocophage 850mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetic Neuropathy, Painful
A Study for the Treatment of Painful Diabetic Neuropathy
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
- Trial name
- NCT00058968
- Testing
- Duloxetine hydrochloride
- Where
- United States
- Volunteers
- 660 people
- Sponsor
- Eli Lilly and Company
Infection, Soft Tissue, Infection, Wound
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic…
- Conditions
- Infection, Soft Tissue, Infection, Wound, Cellulitis, Diabetic Foot Ulcer
- Trial name
- DAD (NCT01238276)
- Testing
- Cefazolin, Silberg Tissue Preparation System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sonescence, Inc.
Diabetic Foot Ulcer
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer).
- Trial name
- DFU (NCT06852976)
- Testing
- 0.75% MDI-1228_mesylate gel plus Standard of Care, Standard of Care Alone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge…
- Conditions
- Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
- Trial name
- NOH304 (NCT01132326)
- Testing
- Droxidopa
- Volunteers
- 350 people
- Sponsor
- Chelsea Therapeutics
Diabetic Neuropathy, Painful
Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if…
- Trial name
- NCT00159679
- Testing
- Pregabalin
- Where
- 30 sites in United States
- Volunteers
- 167 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Diabetic Foot, Foot Ulcer, Diabetic
Use of Santyl in Diabetic Foot Ulcers
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers…
- Trial name
- NCT02581488
- Testing
- Santyl, Product containing silver
- Where
- 13 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited