Clinical trials: Neuropathy, Diabetic
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcer
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
- Trial name
- NCT05046158
- Testing
- Transforming Powder Dressing, Standard of care topical wound agents and dressings
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- ULURU Inc.
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging US
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- NCT05415683
- Testing
- DV-SSP Imaging
- Where
- 11 sites in United States
- Volunteers
- 400 people
- Sponsor
- SpectralMD
Diabetic Neuropathy, Painful
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.
- Trial name
- NCT00785577
- Testing
- Pregabalin, LY545694 21 mg, LY545694 49 mg
- Where
- 13 sites in United States, Mexico and 1 more
- Volunteers
- 273 people
- Sponsor
- Eli Lilly and Company
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Diabetic Foot Ulcers
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT00432965
- Testing
- Moist Wound Therapy, VAC Therapy
- Where
- 25 sites in United States, Canada
- Volunteers
- 335 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcers
Evaluation of Woulgan in Diabetic Foot Ulcer
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite.
- Trial name
- NCT02631512
- Testing
- Woulgan Gel, Intrasite Hydrogel
- Where
- 3 sites in Sweden, United Kingdom
- Volunteers
- 62 people
- Sponsor
- Biotec Pharmacon ASA
Diabetic Peripheral Neuropathy
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic…
- Trial name
- NCT00553592
- Testing
- Bicifadine
- Where
- United States
- Volunteers
- 336 people
- Sponsor
- XTL Biopharmaceuticals
Diabetic Foot
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
To determine the efficacy of full-thickness placental allograft in chronic wound healing
- Trial name
- NCT03708029
- Testing
- Revita Allograft
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- StimLabs
Wounds and Injuries
Managing Wounds With Allevyn Life in a Home Health Care Environment
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care.
- Trial name
- NCT02776800
- Testing
- Allevyn Life, Foam dressing with an integrated adhesive border
- Where
- 3 sites in United States
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers.
- Trial name
- TriO FITT (NCT06003400)
- Testing
- Study treatment administration (TriO FITT), Physical Examination, Vital Signs
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Tri.O Medical LTD
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
- Trial name
- NCT06141811
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- 4 sites in South Korea
- Volunteers
- 104 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Peripheral Neuropathy
Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment…
- Trial name
- NCT03077893
- Testing
- Active Provant Therapy System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Regenesis Biomedical, Inc.
Diabetic Neuropathy, Painful
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy
- Trial name
- NCT00381719
- Testing
- AGN 203818
- Where
- United States
- Volunteers
- 330 people
- Sponsor
- Allergan
Diabetic Polyneuropathy
Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)
The primary objective of the trial is to determine the optimal dose of orally (tablet) administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP).
- Trial name
- NCT00328601
- Testing
- Thioctic Acid
- Where
- 5 sites in Israel, Russia
- Volunteers
- 170 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Trial name
- FOCUS 3D (NCT07632001)
- Testing
- Miro3D Wound Matrix, Standard of Care
- Where
- 14 sites in United States
- Volunteers
- 180 people
- Sponsor
- Reprise Biomedical, Inc.
Painful Diabetic Neuropathy
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
- Trial name
- NCT04857957
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centrexion Therapeutics
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S