Clinical trials: Neuropathy, Diabetic
Foot Ulcer, Diabetic
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
- Trial name
- NCT01228500
- Testing
- PriMatrix
- Where
- United States
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers
The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers.
- Trial name
- NCT01824407
- Testing
- Electrohydraulic-generated shock wave
- Where
- 19 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- SANUWAVE, Inc.
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Diabetic Foot Ulcer, Wagner Grade 1 - 2
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the…
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Trial name
- NCT07396376
- Testing
- ELU42 Topical Spray
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Eluciderm Inc
Type 2 Diabetic Peripheral Neuropathy (DPN)
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician.
- Trial name
- NCT00726713
- Testing
- Metanx (a medical food)
- Where
- 6 sites in United States
- Volunteers
- 214 people
- Sponsor
- Pamlab, Inc.
Diabetic Neuropathies, Diabetic Neuropathy Peripheral
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK16149 Capsules and Metformin Hydrochloride Tablets
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
- Trial name
- NCT04841720
- Testing
- HSK16149, Metformin Hydrochloride tablet, HSK16149+Metformin（phase 3）
- Where
- China
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Wound, Venous Leg Ulcer
Geko™ Cross Therapy Registry - Wound
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term…
- Conditions
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
- Trial name
- CTR-Wound (NCT05007301)
- Testing
- geko device
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 2,500 people
- Sponsor
- Firstkind Ltd
Diabetic Peripheral Neuropathy
DEXINEURO® Tab on Blood Glucose Reduction in Patients With Type 2 Diabetes Accompanied by Diabetic Peripheral Neuropathy
This study is to evaluate the efficacy of DEXINEURO® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type 2 diabetes accompanied by…
- Trial name
- NCT06191614
- Where
- South Korea
- Volunteers
- 528 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Diabetic Foot, Quality of Life
Patient Empowerment Study
The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics…
- Conditions
- Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot
- Trial name
- NCT04537676
- Testing
- No intervention, this is an observational study
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Podimetrics, Inc.
Diabetic Neuropathy, Painful
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes.
- Trial name
- NCT01214590
- Testing
- VascuActive device
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- VascuActive LTD
Diabetic Foot Ulcer
Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers
Clinical Trial Phase III-b Study Sponsor: European Egyptian Pharmaceutical Industries Sample Size: 120 patients (60 per arm) Study Population: Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if…
- Trial name
- PED111 (NCT01531517)
- Testing
- Royal Jelly and Panthenol (PedyPhar® Ointment), Panthenol Ointment
- Where
- 2 sites in Egypt
- Volunteers
- 47 people
- Sponsor
- European Egyptian Pharmaceutical Industries
Diabetic Neuropathy, Painful, Diabetic Polyneuropathy
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure…
- Trial name
- NCT01063868
- Testing
- Tapentadol extended release (ER), Oxycodone controlled release (CR)
- Where
- 23 sites in United States
- Volunteers
- 47 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetic Foot Ulcer, Diabetic Foot
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes Mellitus, Type 2
- Trial name
- NCT03583593
- Testing
- DIAMEL
- Where
- Cuba
- Volunteers
- 100 people
- Sponsor
- Catalysis SL
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Wound Healing, Diabetic Foot
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Trial name
- NCT06640985
- Testing
- EDX110 wound dressing system
- Where
- Chile
- Volunteers
- 43 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Infection
PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers
The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment…
- Trial name
- PHOTOFINISH (NCT05613985)
- Testing
- Usual Care alone, System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
- Where
- 7 sites in Italy
- Volunteers
- 78 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
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.
Herpes Zoster, Neuralgia
Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products.
- Conditions
- Herpes Zoster, Neuralgia, Pain, HIV Infections
- Trial name
- NCT00082316
- Testing
- Capsaicin Dermal Patch
- Where
- 17 sites in United States
- Sponsor
- NeurogesX