Clinical trials: Foot Ulcer, Diabetic
Diabetic Foot Ulcer
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R).
- Trial name
- NCT01181453
- Testing
- Dermagraft, Comparator
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Diabetic Foot, Varicose Ulcer
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Trial name
- NCT00521027
- Testing
- Versajet Hydrosurgery System, Conventional surgical debridement techniques
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Smith & Nephew, Inc.
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
Diabetic Foot Ulcers, Venous Ulcers
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the…
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- CMS (NCT02071979)
- Testing
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections
- Where
- 6 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Arteriocyte, Inc.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
- Trial name
- NCT03183726
- Testing
- ALLO-ASC-DFU
- Volunteers
- 4 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcers
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in…
- Trial name
- STRIDE 1 (NCT01830348)
- Testing
- DSC127
- Where
- 25 sites in United States
- Volunteers
- 266 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects.
- Trial name
- STRIDE 5 (NCT01840085)
- Testing
- 0.03% DSC127 topical gel
- Where
- 21 sites in United States
- Volunteers
- 261 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a…
- Trial name
- STRIDE 2 (NCT01849965)
- Testing
- DSC127, Standard of Care gel, Aquasite
- Where
- 56 sites in United States, Canada and 2 more
- Volunteers
- 396 people
- Sponsor
- Integra LifeSciences Corporation
Foot Ulcer, Diabetic
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without…
- Trial name
- NCT01270633
- Testing
- PriMatrix, Standard of Care
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Diabetes Mellitus, Foot Ulcer
Betafoam Diabetes Mellitus Foot Study
This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new dressing that contains povidone-iodine, in patients with diabetes foot ulcer.
- Trial name
- NCT02732886
- Testing
- Medifoam®, Betafoam®
- Where
- South Korea
- Volunteers
- 71 people
- Sponsor
- Mundipharma Korea Ltd
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
Chronic Diabetic Foot Ulcers
Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers
A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers
- Trial name
- *OTI-15-01 (NCT02571738)
- Testing
- CHAM, Control
- Where
- 18 sites in United States
- Volunteers
- 108 people
- Sponsor
- Osiris Therapeutics
Diabetic Foot Ulcer
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
- Trial name
- NCT02619877
- Testing
- ALLO-ASC-DFU, Standard therapy
- Where
- 4 sites in South Korea
- Volunteers
- 59 people
- Sponsor
- Anterogen Co., Ltd.
Foot Ulcer, Diabetic
The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)
The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot…
- Trial name
- ADHOC (NCT02334241)
- Testing
- Sorbact®, Best local cares
- Where
- 15 sites in Czechia, France and 1 more
- Volunteers
- 200 people
- Sponsor
- INRESA Pharma
Diabetic Foot Ulcers
dHACM 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 plus standard of care. Safety and effectiveness will be monitored throughout the study.
- Trial name
- NCT02587104
- Testing
- EpiFix
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- MiMedx Group, 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.
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Foot Ulcer, Diabetic
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
- Trial name
- NCT02675855
- Testing
- GrafixPRIME®, Dressing Application, Off-loading (walking boot)
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Osiris Therapeutics