Clinical trials: Foot Ulcers, Diabetic
Diabetic Foot Ulcer
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of…
- Trial name
- CHITOWOUND (NCT04178525)
- Testing
- ChitoCare gel
- Where
- 5 sites in Croatia, Slovenia
- Volunteers
- 46 people
- Sponsor
- Primex ehf
Diabetic Foot Ulcer
DHACM vs Other Commercially Available Treatments
The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot…
- Trial name
- NCT01921491
- Testing
- Dressing Application, Offloading
- Where
- 2 sites in United States
- Volunteers
- 105 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcers
Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer
Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials.
- Trial name
- NCT02402374
- Testing
- Autologous platelet rich plasma gel
- Where
- United States
- Volunteers
- 192 people
- Sponsor
- Regen Lab SA
Diabetic Neuropathic Ulcer
Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational…
- Trial name
- NCT03267784
- Testing
- allo-APZ2-DFU
- Where
- 7 sites in Germany
- Volunteers
- 23 people
- Sponsor
- RHEACELL GmbH & Co. KG
Diabetic Foot Ulcer
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at…
- Trial name
- NCT03204149
- Testing
- MC-8XL low level laser device and Standard wound care
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Medical Coherence LLC
Diabetic Foot Ulcers
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
- Trial name
- NCT00563394
- Testing
- ofloxacin, MSI-78
- Where
- United States
- Volunteers
- 584 people
- Sponsor
- Abeona Therapeutics, Inc
Diabetic Foot Ulcers
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
- Trial name
- NCT00563433
- Testing
- ofloxacin, MSI-78
- Where
- United States
- Volunteers
- 342 people
- Sponsor
- Abeona Therapeutics, Inc
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.
Foot Ulcer, Diabetic
Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
- Trial name
- NCT04400344
- Testing
- No intervention
- Where
- United States
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Podimetrics, Inc.
Diabetic Foot Ulcer
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers…
- Trial name
- NCT03547635
- Testing
- AMNIOEXCEL Plus Amniotic Membrane, A Marketed Comparator, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 116 people
- Sponsor
- Integra LifeSciences Corporation
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
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 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
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.
Foot Ulcer, Diabetic
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
- Trial name
- NCT02647346
- Testing
- Daily use of podimetrics smart-foot mat
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- Podimetrics, Inc.
Diabetic Foot Ulcers
Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers
This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in…
- Trial name
- NCT02880592
- Testing
- Affinity Allograft, Standard of care
- Where
- 8 sites in United States
- Volunteers
- 89 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Affinity Prospective Diabetic Foot Trial Crossover Group
This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain…
- Trial name
- NCT03205436
- Testing
- Affinity human amniotic membrane
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Organogenesis
Neuropathic Foot Ulcer, Foot Ulcer
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.
- Trial name
- VHT1 (NCT04244201)
- Testing
- Vaporous Hyperoxia Therapy
- Volunteers
- 31 people
- Sponsor
- Vaporox
Diabetic Foot Ulcers
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.
- Trial name
- NCT00958711
- Testing
- Unite Biomatrix, Saline and Gauze
- Where
- 11 sites in United States
- Volunteers
- 90 people
- Sponsor
- Baxter Healthcare Corporation
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.