Clinical trials: Venous Leg Ulcer (VLU)
Venous Ulcer of Leg
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will…
- Trial name
- IGuideU (NCT04696354)
- Testing
- IVUS, Continued Compression Therapy/Stockings
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
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
Venus Leg Ulcers
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
The objectives of this study are: To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo…
- Trial name
- H2H (NCT06690177)
- Testing
- EscharEx (EX-03), Non-surgical standard of care (NSSOC)
- Where
- 2 sites in United States, Poland
- Volunteers
- 45 people
- Sponsor
- MediWound Ltd
Venous Leg Ulcer
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
- Trial name
- VIEW-VLU (NCT03257254)
- Testing
- Varithena
- Where
- 14 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Boston Scientific Corporation
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
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
Efficacy and Safety of URGOBD001 Compression System
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous…
- Trial name
- FUTURE (NCT05158764)
- Testing
- Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification
- Where
- France
- Volunteers
- 178 people
- Sponsor
- Laboratoires URGO
Venous Leg Ulcer, Leg Ulcer
Efficacy Study for Geko Device in VLU Patients (Canada)
The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go…
- Conditions
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- Trial name
- NCT05057793
- Testing
- geko
- Where
- 3 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Firstkind Ltd
Venous Leg Ulcer (VLU)
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo).
- Trial name
- NCT01970657
- Testing
- No treatment specified, No treatment
- Where
- 43 sites in Belgium, Czechia and 3 more
- Volunteers
- 221 people
- Sponsor
- Healthpoint
Venous Leg Ulcer (VLU), Compression Bandages
A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France.
- Trial name
- NCT07600489
- Testing
- Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®), Wound Dressing Material
- Where
- 8 sites in France
- Volunteers
- 386 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot 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 diabetic foot and…
- Trial name
- CAMPLIFE (NCT06562296)
- Testing
- Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 292 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers.
- Trial name
- NCT06515093
- Testing
- PelloGraft, SanoGraft
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Surgenex
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
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
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Venous Leg Ulcer, Venous Stasis Ulcer
Safety Follow-Up to HP 802-247-09-015
This is a 24-week observational follow safety study for Study 802-247-09-015.
- Trial name
- NCT00900029
- Testing
- No HP802 Treatment, No HP802 Vehicle Treatment
- Where
- 30 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Healthpoint
Venus Leg Ulcer (VLU), VLU
Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)
The goal of this clinical trial is to learn if Borate-based Bioactive Glass Fiber Matrix (BBGFM) can help heal Venous Leg Ulcers (VLU) that have not closed with standard treatment. The main question it aims to answer is: 1.
- Conditions
- Venus Leg Ulcer (VLU), VLU, Venus Leg Ulcer, Venus Ulcer
- Trial name
- NCT07647705
- Testing
- Borate Based Bioactive Glass Fiber Matrix (BBGFM)
- Volunteers
- 110 people
- Sponsor
- ETS Wound Care, LLC
Venous Leg Ulcer, Leg Ulcers Venous
Efficacy Study for Geko Device in VLU Patients
Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg
- Trial name
- NCT03396731
- Testing
- geko™ medical device
- Where
- 23 sites in United Kingdom
- Volunteers
- 171 people
- Sponsor
- Firstkind Ltd