Clinical trials: Diabetic Foot
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.
Venous Hypertension Ulcers, Venous Stasis Ulcer
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Trial name
- MUSTCOOL (NCT02626156)
- Testing
- Cooling gel pack, Cooling cotton pack
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medical University of South Carolina
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
Bacterial Infections, Diabetic Foot
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
- Conditions
- Bacterial Infections, Diabetic Foot, Osteomyelitis
- Trial name
- NCT00366249
- Testing
- Tigecycline, Ertapenem
- Where
- 211 sites in United States, Argentina and 37 more
- Volunteers
- 1,061 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
Diabetic Foot Ulcers, Diabetic Foot Wounds
Wound Edge Changes Following Treatment With Santyl
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
- Trial name
- NCT01197898
- Testing
- Collagenase Santyl Ointment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Healthpoint
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
Diabetes Mellitus, Diabetic Peripheral Neuropathy
Immunonutrition for Diabetic Foot Ulcers
Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death.
- Conditions
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Diabetic Foot Ulcer
- Trial name
- NCT05281562
- Testing
- Lovaza, L-Arginine Powder, Vitamin C
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Prisma Health-Midlands
Pain
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients.
- Trial name
- NCT00580294
- Testing
- Oxymorphone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Neuropathic Diabetic Ulcer - Foot
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus…
- Trial name
- NCT01060670
- Testing
- Integra® Dermal Regeneration Template, Conventional Wound Therapy
- Where
- 33 sites in United States, Netherlands Antilles
- Volunteers
- 545 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot, Diabetic Ulcer of Left Foot
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban…
- Conditions
- Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
- Trial name
- NCT05203471
- Testing
- integrated care model
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Wisconsin, Madison
Neuropathy, Diabetic, Neuropathy;Peripheral
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic…
- Conditions
- Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful
- Trial name
- NCT05291975
- Testing
- Erchonia® EVRL™
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Erchonia Corporation
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
Diabetic Neuropathies
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
- Trial name
- FOCA-II (NCT04008745)
- Testing
- Educational and home-based physical therapy by foot-related exercises
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- University of Sao Paulo General Hospital
Diabetes Mellitus, Diabetic Neuropathies
Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies, Foot Complications
- Trial name
- DFE (NCT01941719)
- Testing
- Enhanced foot care education, Standard Foot Care Education
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Temple University
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
- Trial name
- DULCIS (NCT02677779)
- Testing
- CO2 laser, traditional surgery
- Volunteers
- 20 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Diabetic Foot Ulcer
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
- Trial name
- NCT01951768
- Testing
- Garamycin Sponge (Gentamicin-Collagen sponge), Systemic Antibiotic
- Where
- Switzerland
- Volunteers
- 88 people
- Sponsor
- University Hospital, Geneva
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 Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint