The GORE® VIAFORT Vascular Stent Iliofemoral Study
Venous ThrombosesVenous Disease8 moreThis study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.
Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds
Pressure InjuryVenous Leg Ulcer5 moreThe goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care). The main questions it aims to answer are: What is the cost-savings of using NanoSALV? Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency? Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients? Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care? Does NanoSALV reduce healing time for chronic wounds compared to standard of care? The sequence and duration of the trial is as follows: Required data will be collected at enrollment to provide a baseline (Day 0) measure. The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway. In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required. Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements. A patient satisfaction survey will be collected post-control and post-intervention periods One week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use. Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.
Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
Diabetic Foot UlcerVenous Leg Ulcer3 moreEvaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous...
Venous Leg UlcerThe laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.
Total Contact Soft Cast in Diabetic Foot Ulcers
Diabetic Foot UlcerDiabetes Mellitus8 moreTo determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg...
Venous Leg UlcerA Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy with Standard of Care to Standard of Care alone for Chronic Venous Leg Ulcers over the course of 4 weeks
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of...
Chronic Ulcer of Lower ExtremityThe purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
PLASOMA Efficacy & Technology Health (PETH) Study
Venous Leg UlcerThis study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad. The intention is that the data obtained with this study will be used to: Demonstrate comparative performance of PLASOMA (for two treatment frequencies) Provide evidence for health technology assessments (HTA) of PLASOMA
The GORE® VIAFORT Vascular Stent IVC Study
Venous ThrombosesVenous Disease8 moreThis study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
Venous Leg UlcerThe purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg ulcer .