Clinical trials: Foot Injury
Wound Heal, Diabetic Foot Ulcer
EDX110 Randomized Control Trial for Treatment of DFUs
Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing…
- Trial name
- NCT07209358
- Testing
- EDX110
- Where
- 4 sites in United States
- Volunteers
- 298 people
- Sponsor
- ConvaTec Inc.
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard…
- Conditions
- Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT05243810
- Testing
- EPC Silver Wound Gel
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Exciton Technologies Inc.
Diabetic Foot Ulcers
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot…
- Trial name
- PL-5 (NCT06189638)
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging EU/UK
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- WAUSI EU/UK (NCT05581966)
- Testing
- DV-SSP Imaging
- Where
- Ireland
- Volunteers
- 72 people
- Sponsor
- SpectralMD
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Hallux Limitus
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.
- Trial name
- NCT00717691
- Testing
- Metatarsophalangeal Extension Dynasplint System, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dynasplint Systems, Inc.
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 Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-South (NCT01217463)
- Testing
- Trafermin 0.01% spray
- Where
- 24 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Olympus Biotech 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
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Wound Healing
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
- Trial name
- NCT01022216
- Testing
- Procellera™ Wound Dressing with V.A.C.® Therapy, V.A.C.® Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vomaris Innovations
Diabetic Foot Ulcer
Prospective, Multicenter, RCT of the Tenex Ultrasound System
The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.
- Trial name
- NCT06137222
- Testing
- Tenex TXB MicroTip Ultrasound system plus SOC, Standard of Care for diabetic foot ulcer
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Tenex Health Inc.
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging US
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- NCT05415683
- Testing
- DV-SSP Imaging
- Where
- 11 sites in United States
- Volunteers
- 400 people
- Sponsor
- SpectralMD
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 Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer (DFU), Lower Extremity
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care.
- Trial name
- NCT07116876
- Testing
- Graft Application, Wound Dressing Material
- Where
- 17 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeNet Health
Diabetic Foot Ulcer
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.
- Trial name
- NCT01657474
- Testing
- Weekly application of EpiFix plus standard of care, Biweekly application of EpiFix plus standard of care
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MiMedx Group, Inc.