Clinical trials: Wound Management
Wounds and Injuries
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies…
- Trial name
- NCT00552643
- Testing
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Where
- 6 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Polyheal Ltd.
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
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
- Trial name
- VHTDFU2 (NCT04210609)
- Testing
- Vaporous Hyperoxia Therapy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vaporox
Radiation Dermatitis
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of…
- Trial name
- NCT05553392
- Testing
- StrataXRT, Aquaphor
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Stratpharma AG
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Spinal Cord Injury
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a…
- Trial name
- NCT00500812
- Testing
- Cethrin
- Where
- 8 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Diabetic Neuropathy, Chemotherapy Induced Neuropathy
A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy
A clinical outcomes study measuring reduction in pain and numbness experienced in four types of peripheral neuropathy patients during 60 day administration of the an amino acid formulation.
- Conditions
- Diabetic Neuropathy, Chemotherapy Induced Neuropathy, HIV Neuropathy, Trauma Induced Neuropathy
- Trial name
- Neuron012703 (NCT01537705)
- Testing
- Neuron012703 (Medical Food)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Targeted Medical Pharma
Minor Traumatic Brain Injury (TBI)
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01923441
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Spasticity
Continuous Intrathecal Baclofen Infusion for Chronic Spasticity
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.
- Trial name
- CIBI (NCT01051128)
- Testing
- Prometra Programmable Implantable Pump System
- Sponsor
- Flowonix Medical
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Wound Healing, Diabetic Foot
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Trial name
- NCT06640985
- Testing
- EDX110 wound dressing system
- Where
- Chile
- Volunteers
- 43 people
- Sponsor
- ConvaTec Inc.
Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed…
- Conditions
- Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds
- Trial name
- NCT01417208
- Testing
- SNaP® Wound Care System
- Where
- United Kingdom
- Sponsor
- KCI USA, Inc
Surgical Wound
Regenn® Therapy System Safety Study
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical…
- Trial name
- NCT06259409
- Testing
- Regenn® Negative Pressure Therapy System, Prevena™ Incision Management System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Progenerative Medical, Inc
Trauma-related Wound, Surgical Wound, Recent
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds.
- Trial name
- NCT01417234
- Testing
- SNaP® Wound Care System
- Where
- United States
- Volunteers
- 30 people
- 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.
Wound Infection
Biofilm Correlation and Validation
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm.
- Trial name
- NCT05196880
- Testing
- MolecuLight DX Imaging Device
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- MolecuLight Inc.
Acute Radiation Syndrome
A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011
This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.
- Trial name
- NCT03585803
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Wounds, Leg Ulcers
The AutoloGel™ Post-Market Surveillance (TAPS) Program
AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
- Conditions
- Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers
- Trial name
- TAPS (NCT00762138)
- Testing
- AutoloGel System
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Cytomedix