Clinical trials: Leg Ulcer
Diabetic Foot Ulcers
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
- Trial name
- NCT05417425
- Testing
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Omeza, LLC
Diabetic Foot
BE STUDY OF METFORMIN GSK 1000mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 199/11 (NCT01710553)
- Testing
- Glucophage 1000mg, Metformin GSK 1000mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited
Lower Limb Ulcers
VergenixTM Flowable Gel in Patients With Lower Limb Ulcers
Vergenix Flowable Gel is indicated for the management of acute and chronic wounds
- Trial name
- CP-FG-001 (NCT02598180)
- Testing
- VergenixTM Flowable Gel
- Where
- 4 sites in Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Collplant
Diabetic Foot Ulcers
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care…
- Trial name
- NCT00761176
- Testing
- The Provant Therapy System
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.
Venous Leg Ulcer, Venous Stasis
SkinTE® in the Treatment of Venous Leg Wounds
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings…
- Conditions
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- Trial name
- NCT03881267
- Testing
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Application, Fibracol Wound Dressing
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- PolarityTE
Chronic Wounds With Different Etiologies
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of…
- Trial name
- NCT01750203
- Testing
- Swabs
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Venous Thromboses, Venous Stasis
Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow
This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device.
- Trial name
- NCT05087108
- Testing
- OsciPulse system, Reference Therapy 1, Refence Therapy 2
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- OsciFlex LLC
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.
Venous Leg Ulcer
HM242-Solution vs Comparator
The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing.
- Trial name
- NCT04902612
- Testing
- HM242-Solution, Saline
- Where
- 2 sites in Italy
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcers
Safety Study of Topical Human FGF-1 for Wound Healing
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
- Trial name
- NCT00916292
- Testing
- FGF-1 141
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Phage Pharmaceuticals, Inc.
Venous Ulcer
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed.
- Trial name
- XCell (NCT00446823)
- Testing
- XCell cellulose wound dressing, Impregnated gauze dressing
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Xylos Corporation
Diabetic Ulcer
Evaluation of Topical Wound Oxygen (two2) Therapy
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
- Trial name
- NCT00871312
- Testing
- Topical wound oxygen therapy
- Where
- 3 sites in United States, Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- AOTI Ltd.
Diabetic Foot
FeetSee Thermal Images Collection Protocol
The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of…
- Trial name
- NCT05222490
- Testing
- Thermal Camera images acquisition - FeetSee, Thermal Camera images acquisition - Reference
- Where
- Lithuania
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Diabetis JSC
Chronic Wounds
Swab Sample Collection for the Detection of Bacterial Proteases
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of…
- Trial name
- NCT01881815
- Testing
- Swabs
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Venous Leg Ulcer, Venous Insufficiency of Leg
Preliminary Investigation of a Smart Compression Therapy Prototype
Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits.
- Trial name
- PRESUF-VLU (NCT05610241)
- Testing
- Compression Therapy System Prototype, Standard Compression
- Where
- Ireland
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Diabetic Foot, Diabetic Foot Ulcer
SkinTE™ in the Treatment of Diabetic Foot Wounds
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings…
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
- Trial name
- NCT03881254
- Testing
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton, Offloading
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PolarityTE
Venus Leg Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537003
- Testing
- Promogran, Coban 2 layer
- Where
- 7 sites in United States, Germany and 2 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Venous Ulcer, Foot Ulcer, Diabetic
Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity…
- Trial name
- TMArtacent (NCT02838784)
- Testing
- Artacent Human Amniotic Membrane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Tides Medical