Clinical trials: Neuropathy, Diabetic
Diabetic Foot, Chronic Ulcer
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
- Trial name
- NCT04185558
- Testing
- ActiGraft, Standard of Care
- Where
- 16 sites in United States, South Africa and 1 more
- Volunteers
- 119 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer, Pressure Injury
Evaluating Clinical Acceptance of a NPWT Wound Care System
Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- Trial name
- NCT03670225
- Testing
- Invia Motion Endure
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medela AG
Diabetic Neuropathy, Painful
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
- Trial name
- NCT00156078
- Testing
- pregabalin
- Where
- 35 sites in Argentina, Brazil and 17 more
- Volunteers
- 450 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Peripheral Diabetic Neuropathy, Painful Diabetic Neuropathy
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
- Trial name
- NCT06495424
- Testing
- Capsaicin 8%
- Where
- 10 sites in United States
- Volunteers
- 144 people
- Sponsor
- Averitas Pharma, Inc.
Painful Diabetic Neuropathy
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy
The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated…
- Trial name
- PDN-SENSORY (NCT05777317)
- Testing
- 10 kHz SCS, CMM alone
- Where
- 2 sites in United States
- Volunteers
- 143 people
- Sponsor
- Nevro Corp
Diabetic Foot Ulcer
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
- Trial name
- NCT03370874
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcers
Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
- Trial name
- NCT02036528
- Testing
- Gentamicin Topical Gel, Ciprofloxacin, Doxycycline
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Royer Biomedical, Inc.
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot Disease, Diabetic Foot Infection
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk…
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1
- Trial name
- DIAFOOTEM (NCT07910721)
- Testing
- Solsius SelfCare
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Solsius
Venous Leg Ulcer, Diabetic Foot Ulcer
The Omeza Protocol for Chronic Ulcers
This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.
- Trial name
- NCT04198441
- Testing
- Wound dressing
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeza, LLC
Diabetic Foot Ulcer
Prospective, Multicenter, RCT of the Tenex Ultrasound System
The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.
- Trial name
- NCT06137222
- Testing
- Tenex TXB MicroTip Ultrasound system plus SOC, Standard of Care for diabetic foot ulcer
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Tenex Health Inc.
Diabetes, Diabetic Foot Ulcer
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU).
- Conditions
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- Trial name
- NCT02657876
- Testing
- ExpressGraft-C9T1 Skin Tissue
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Diabetic Foot
Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.
- Trial name
- MASTER (NCT06053047)
- Testing
- Bluedrop Monitoring Service (BMS)
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bluedrop Medical Limited
Diabetes
Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain distal symmetric sensorimotor…
- Trial name
- NCT00903851
- Testing
- Lidoderm
- Where
- 4 sites in United States
- Volunteers
- 76 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain
People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP).
- Trial name
- NCT04641273
- Testing
- BAY1817080, Pregabalin
- Where
- 42 sites in Czechia, Denmark and 8 more
- Volunteers
- 154 people
- Sponsor
- Bayer
Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy
A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy…
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Trial name
- NOH301 (NCT00782340)
- Testing
- Droxidopa
- Where
- 21 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Chelsea Therapeutics
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-South (NCT01217463)
- Testing
- Trafermin 0.01% spray
- Where
- 24 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Olympus Biotech Corporation
Chronic Pain
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral…
- Trial name
- INSPIRE (NCT05302063)
- Testing
- Spinal Cord Stimulation (SCS)
- Where
- Spain
- Volunteers
- 28 people
- Sponsor
- Boston Scientific Corporation
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
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