Clinical trials: Leg Ulcers
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05409976
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 136 people
- Sponsor
- W.L.Gore & Associates
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
Venous Stasis Ulcer, Venous Leg Ulcer
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional…
- Trial name
- NCT04647240
- Testing
- MTX-001 (human amniotic fluid)
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Merakris Therapeutics
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Vascular, DVT - Deep Vein Thrombosis
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually.
- Conditions
- Vascular, DVT - Deep Vein Thrombosis, Post Thrombotic Syndrome, Venous Ulcer of Leg
- Trial name
- NCT07762222
- Testing
- dedicated venous stenting, Dedicated venous stent / iliofemoral dedicated venous stenting
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Ain Shams University
Venous Ulcer of Leg
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
investigates the comparative effectiveness of two interventions aimed at promoting the healing of venous leg ulcers-a common chronic condition characterized by impaired venous return and poor wound healing in the lower…
- Trial name
- Ulcer (NCT07763782)
- Testing
- Dose-Response Structured CMP Activation, Active Control
- Volunteers
- 80 people
- Sponsor
- MTI University
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent)…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05489588
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 24 sites in United States
- Volunteers
- 165 people
- Sponsor
- W.L.Gore & Associates
Venous Leg Ulcer (VLU)
OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.
The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound…
- Trial name
- NCT07754526
- Testing
- Omeza OCM™ Wound Matrix, Routine Care
- Where
- United States
- Volunteers
- 254 people
- Sponsor
- Omeza, LLC
Venous Leg Ulcer (VLU)
Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.
- Trial name
- EVOLVE (NCT07230340)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Cellution Biologics
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Venous Leg Ulcer
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
The 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.
- Trial name
- NCT03716167
- Testing
- Summus Laser
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Diabetic Foot Ulcer, Venous Leg Ulcer
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal…
- Trial name
- NCT06453187
- Testing
- Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers, AmnioExcel Plus for Venous Leg Ulcers
- Where
- 13 sites in United States
- Volunteers
- 350 people
- Sponsor
- Integra LifeSciences Corporation
Wound, Foot, Diabetic Foot Ulcer (DFU)
CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs
CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to…
- Conditions
- Wound, Foot, Diabetic Foot Ulcer (DFU), Venus Leg Ulcer
- Trial name
- CAMPR-II (NCT07701590)
- Testing
- Microlyte®, IP 1: Membrane Wrap - Hydro
- Where
- 7 sites in United States
- Volunteers
- 147 people
- Sponsor
- Capsicure, LLC
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcer (VLU)
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers
- Trial name
- NCT07692178
- Testing
- EX-03
- Volunteers
- 20 people
- Sponsor
- MediWound Ltd
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Diabetic Foot, Diabetic Foot Ulcer
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg
- Trial name
- NCT05579743
- Testing
- Remote wound monitoring technology
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Johns Hopkins University
Venous Leg Ulcer, Chronic Wounds
Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT07335861
- Testing
- Hyalomatrix, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 122 people
- Sponsor
- NuScience Medical Biologics, LLC
Venous Leg Ulcer
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers.
- Trial name
- NCT05549609
- Testing
- XSTEM-VLU, Vehicle
- Where
- 2 sites in Sweden
- Volunteers
- 6 people
- Sponsor
- Xintela AB
Chronic Venous Leg Ulcers
Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults
The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at…
- Trial name
- NCT03576989
- Testing
- EPA+DHA
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Ohio State University