Clinical trials: Diabetic Neuropathy
Diabetic Foot Ulcer (DFU)
Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin…
- Trial name
- NCT07046403
- Testing
- High Purity Type-I Collagen-based Skin Substitute and SOC, Dehydrated Human Amnion / Chorion Membrane and SOC
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Diabetic Foot, Diabetic Foot Ulcer
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg
- Trial name
- NCT05579743
- Testing
- Remote wound monitoring technology
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Johns Hopkins University
Diabetic Peripheral Neuropathy
Electrical Stimulation for Improving Balance in Diabetes
This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application.
- Trial name
- NCT02337218
- Testing
- SENSUS Pain Management System
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Peripheral Neuropathy, Diabetes
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
- Trial name
- RELIEF-DPN 1 (NCT04455633)
- Testing
- LX9211
- Where
- 44 sites in United States
- Volunteers
- 319 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetic Peripheral Neuropathy
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
- Trial name
- NCT05660538
- Testing
- Suzetrigine, Pregabalin
- Where
- 50 sites in United States
- Volunteers
- 194 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-2 (NCT02447172)
- Testing
- Gentamicin Collagen sponge
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 524 people
- Sponsor
- Innocoll
Diabetic Foot
Less Infections for the Diabetic Foot
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
- Trial name
- NCT03615807
- Testing
- Surgical debridement (if needed), Microbiological sampling, Revascularisation (if needed).
- Where
- Switzerland
- Volunteers
- 182 people
- Sponsor
- University Hospital, Geneva
Diabetes
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
- Trial name
- NCT02211495
- Testing
- GEKO device, Best Medical Therapy
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Diabetic Neuropathies
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.
- Trial name
- NCT00408993
- Testing
- Duloxetine Hydrochloride
- Where
- 7 sites in China
- Volunteers
- 215 people
- Sponsor
- Eli Lilly and Company
Lower Leg Wound
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
- Trial name
- WoundWand (NCT01924806)
- Testing
- WoundWand™ Debridement Device, Standard of Care sharp debridement
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 11 people
- Sponsor
- Smith & Nephew, Inc.
Diabetes, Diabetic Foot Ulcer
Electrical Stimulation to Accelerate Wound Healing
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed…
- Conditions
- Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy, Peripheral Arterial Disease
- Trial name
- NCT03821675
- Testing
- Electrical Stimulation - Active
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Baylor College of Medicine
Diabetes
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.
- Trial name
- NCT02412852
- Testing
- Sodium nitrite
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- TheraVasc Inc.
Foot Ulcer, Diabetic
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
- Trial name
- NCT01858545
- Testing
- MatriStem, Cellular Dermal Replacement Tissue
- Where
- 9 sites in United States
- Volunteers
- 56 people
- Sponsor
- Integra LifeSciences Corporation
Painful Peripheral Diabetic Neuropathy
Nociceptive Pain Fiber Response
This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot.
- Trial name
- NCT02696070
- Testing
- Provant Therapy System
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.
Painful Diabetic Neuropathy
Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).
- Trial name
- EMPADINE (NCT03297294)
- Testing
- EMA401
- Where
- 64 sites in Australia, Austria and 14 more
- Volunteers
- 142 people
- Sponsor
- Novartis Pharmaceuticals
Abscess, Wound Infection
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the…
- Conditions
- Abscess, Wound Infection, Diabetic Foot, Ulcer
- Trial name
- NCT00402727
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
- Where
- 123 sites in Austria, Belgium and 18 more
- Volunteers
- 813 people
- Sponsor
- Bayer