Clinical trials: Foot Ulcers, Diabetic
Diabetes, Ulceration
Shear and Pressure Reducing Insoles for the Diabetic Foot
We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear.
- Conditions
- Diabetes, Ulceration, Amputation, Foot Deformity
- Trial name
- GlideSoft (NCT00499356)
- Testing
- pressure reducing insole, GlideSoft®
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- Diabetica Solutions Inc.
Diabetic Foot Ulcer
Study of Oasis Ultra in Diabetic Foot Ulcers
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.
- Trial name
- NCT01835379
- Testing
- Oasis, Standard
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcers
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment.
- Trial name
- NCT02367690
- Testing
- Selinexor, Standard-of-Care, Vehicle Gel
- Where
- New Zealand
- Sponsor
- Karyopharm Therapeutics Inc
Wound Heal, Ulcer
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Trial name
- IDEAL (NCT06616844)
- Testing
- InnovaMatrix® AC
- Where
- 21 sites in United States
- Volunteers
- 235 people
- Sponsor
- ConvaTec Inc.
Foot Ulcer, Diabetic
Evaluation of a Medical Food for Chronic Wounds
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
- Trial name
- NCT00711217
- Testing
- Medical Food, Drink mix calorically similar to experimental product
- Where
- 51 sites in United States, Spain and 2 more
- Volunteers
- 271 people
- Sponsor
- Abbott Nutrition
Diabetic Foot Ulcers
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
- Trial name
- NCT01353495
- Testing
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Stryker Trauma and Extremities
Diabetic Foot Ulcers
Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care…
- Trial name
- NCT02352480
- Testing
- Aurix
- Where
- 20 sites in United States
- Volunteers
- 760 people
- Sponsor
- Nuo Therapeutics
Pressure Ulcer, Diabetic Foot Ulcer
Efficacy of Wound Dressings With Copper Oxide
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles.
- Trial name
- NCT04634838
- Testing
- MedCu Antibacterial Wound Dressings with Copper Oxide
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- MedCu Technologies Ltd.
Diabetic Foot, Foot Ulcer, Diabetic
Use of Santyl in Diabetic Foot Ulcers
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers…
- Trial name
- NCT02581488
- Testing
- Santyl, Product containing silver
- Where
- 13 sites in United States, Canada
- Volunteers
- 102 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.
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Diabetic Foot
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
- Trial name
- NCT00512538
- Testing
- Bi-layered cell therapy (Apligraf)
- Volunteers
- 82 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85…
- Trial name
- NCT06584617
- Testing
- Berovenal®, NU-GEL Hydrogel with Alginate
- Where
- 9 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- VULM s.r.o.
DFU, Neuropathic Diabetic Ulcer - Foot
Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers
The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest.
- Conditions
- DFU, Neuropathic Diabetic Ulcer - Foot, Diabetic Foot Disease
- Trial name
- NCT07222540
- Testing
- SkinTE
- Sponsor
- PolarityTE
Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
OASIS Wound Matrix (Oasis) Mechanism of Action
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
- Trial name
- NCT00570141
- Testing
- OASIS Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Diabetic Peripheral Neuropathic Pain (DPN), Diabetic Peripheral Neuropathy
Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain
The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal…
- Conditions
- Diabetic Peripheral Neuropathic Pain (DPN), Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
- Trial name
- NCT07725419
- Testing
- NMS 460 Pulsed Radio Frequency Device
- Where
- 5 sites in South Africa
- Volunteers
- 92 people
- Sponsor
- Algiamed Technologies USA, Inc.
Diabetic Foot Infection, Diabetic Foot
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot…
- Trial name
- NCT05174806
- Testing
- Topical Pravibismane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Microbion Corporation
Diabetic Foot Ulcer, DFU
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks…
- Conditions
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus
- Trial name
- RENEW (NCT07086443)
- Testing
- Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Sequence LifeScience, Inc.
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD