Clinical trials: Venous Ulcer
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
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
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
Venous Leg Ulcer
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this…
- Trial name
- NCT03796793
- Testing
- Wound Edge Debridement, Standard of Care Treatment
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Miami
Venous Leg Ulcer
Diagnostics in the Leg Ulcer Pathway
This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with…
- Trial name
- NCT06181708
- Testing
- N/A - Questionnaire based study
- Where
- United Kingdom
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Venous Ulcer
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which…
- Trial name
- COMPARACHILLE (NCT04046120)
- Testing
- Heel-free bandage
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Nantes University Hospital
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcers
A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers
Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I…
- Trial name
- NCT06831760
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Dr Naveen Narayan MS, MCh (Plastic Surgery)
Venous Leg Ulcer
VLU Dressing Study
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
- Trial name
- NCT03621592
- Testing
- Cutimed® Sorbact®, Acticoat®
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Miami
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study…
- Trial name
- NCT05873257
- Testing
- Biatain Fiber Ag applied to participants
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Coloplast A/S
Venous Leg Ulcer, Mixed Leg Ulcer
Leg Ulcers Standards of Care Enhancement
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients…
- Trial name
- LUCE (NCT04689009)
- Testing
- EmoLED, current Standards Of Care
- Where
- 5 sites in Italy
- Volunteers
- 83 people
- Sponsor
- Emoled
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
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.
Venous Leg Ulcer
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox…
- Trial name
- Granulox01 (NCT04181320)
- Testing
- Venous Leg Ulcer Standard of Care with Granulox
- Where
- 27 sites in Croatia, Czechia and 5 more
- Volunteers
- 128 people
- Sponsor
- Molnlycke Health Care AB
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
Venous Leg Ulcer
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency.
- Trial name
- NCT03903692
- Testing
- Marine polysaccharide dressing, Carboxymethylcellulose dressing
- Where
- 5 sites in United States
- Volunteers
- 62 people
- Sponsor
- Medline Industries
Venous Leg Ulcer
Early Venous Reflux Ablation Ulcer Trial
The EVRA study evaluates the effects of early endovenous ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomised to receive early endovenous ablation (within 2 weeks) and half to…
- Trial name
- EVRA (NCT03286140)
- Testing
- Early endovenous ablation, Delayed endovenous intervention
- Where
- United Kingdom
- Volunteers
- 450 people
- Sponsor
- Imperial College London
Diabetic Foot Ulcer, Non-healing Wound
Debritom - Micro Water Jet Technology and Wound Healing
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer
- Trial name
- NCT04240574
- Testing
- Debritom
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Stephanie Wu