Clinical trials: Diabetic Feet
Diabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment.
- Trial name
- NCT03717233
- Testing
- Exoskeleton
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Results Group LLC
Diabetic Foot Ulcer
Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers
This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
- Trial name
- NCT02394886
- Testing
- ALLO-ASC-DFU
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- Anterogen Co., Ltd.
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Venous Leg Ulcer, Venous Leg
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the…
- Conditions
- Venous Leg Ulcer, Venous Leg, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- NCT06826339
- Testing
- ACApatch™, caregraFT™, Standard of Care
- Where
- United States
- Volunteers
- 340 people
- Sponsor
- Tiger Biosciences, LLC.
Diabetic Foot Ulcer(s)
Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers
The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
- Trial name
- NCT01717183
- Testing
- Urgo 310 3113
- Where
- France
- Sponsor
- Laboratoires URGO
Foot Ulcer, Diabetic
NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers
This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.
- Trial name
- NCT02461641
- Testing
- NuShield, Affinity, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 96 people
- Sponsor
- NuTech Medical, Inc
Diabetic Foot Ulcer
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer).
- Trial name
- DFU (NCT06852976)
- Testing
- 0.75% MDI-1228_mesylate gel plus Standard of Care, Standard of Care Alone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic
Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
- Conditions
- Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic, Ulcer, Diabetic Foot Ulcer
- Trial name
- SCANX (NCT07360418)
- Testing
- Blue Drop Foot Scanner
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcers
Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.
- Trial name
- NCT02506452
- Testing
- Biovance®, Standard of Care, Diabetic Foot Ulcers
- Where
- 10 sites in United States
- Volunteers
- 51 people
- Sponsor
- Alliqua BioMedical, Inc
Wounds and Injuries, Burns
ACTICOAT™ for the Treatment of Burns and Chronic Wounds
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
- Conditions
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
- Trial name
- NCT02852148
- Testing
- ACTICOAT
- Where
- 3 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcers
dHACM Mesh In the Treatment of Diabetic Foot Ulcers
A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and effectiveness will be monitored throughout the study.
- Trial name
- NCT02589210
- Testing
- EpiFix Mesh
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MiMedx Group, Inc.
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot
The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure
The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397.
- Trial name
- NCT03128320
- Testing
- BAY1193397
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- Bayer
Infection, Soft Tissue, Infection, Wound
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic…
- Conditions
- Infection, Soft Tissue, Infection, Wound, Cellulitis, Diabetic Foot Ulcer
- Trial name
- DAD (NCT01238276)
- Testing
- Cefazolin, Silberg Tissue Preparation System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sonescence, Inc.
Diabetic Foot Ulcers, Diabetic Foot Wounds
Santyl Applications to Diabetic Foot Ulcers
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance.
- Trial name
- NCT02111291
- Testing
- Collagenase SANTYL® Ointment, Hydrogel (if needed) and foam dressing
- Where
- 25 sites in United States, Canada
- Volunteers
- 215 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer, Foot Ulcer
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2…
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound
- Trial name
- NCT05930210
- Testing
- ENERGI-F703 GEL, ENERGI-F703 matched vehicle
- Where
- 24 sites in United States, Taiwan
- Volunteers
- 230 people
- Sponsor
- Energenesis Biomedical Co., Ltd.
Diabetic Foot Ulcer, Diabetic Foot
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
- Trial name
- NCT04564443
- Testing
- Medaxis Debritom+, Sharp Surgical Debridement, Additional Outer Dressing Application
- Where
- 6 sites in United States
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Medaxis, LLC
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.