Clinical trials: Venous Stasis Ulcer
Venous Stasis Ulcers
Wound Fluid Protease Levels During Use of Novel Wound Dressing
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing.
- Trial name
- NCT01567150
- Testing
- Novel Dressing
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Hollister Incorporated
Lymphedema
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.
- Trial name
- NCT02284373
- Testing
- Flexitouch for 1 month in addition to routine wound care, Routine wound care for venous ulcers and lymphedema, Flexitouch pneumonic compression
- Volunteers
- 39 people
- Sponsor
- NYU Langone Health
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 Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Venous Leg Ulcer
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised.
- Trial name
- PD-497314 (NCT02921750)
- Testing
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Where
- 33 sites in Czechia, Denmark and 4 more
- Volunteers
- 248 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01656889
- Testing
- HP-802-247, Vehicle
- Where
- 50 sites in United States, Canada
- Volunteers
- 447 people
- Sponsor
- Healthpoint
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
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
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
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
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 Stasis Ulcer
Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers
The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.
- Trial name
- NCT01376050
- Testing
- Erchonia ML Scanner (MLS)
- Where
- 2 sites in United States, France
- Volunteers
- 24 people
- Sponsor
- Erchonia Corporation
Varicose Ulcer
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings.
- Trial name
- NCT01671748
- Testing
- MIST ultrasound therapy, Standard Care
- Where
- United Kingdom
- Volunteers
- 47 people
- Sponsor
- Cardiff and Vale University Health Board
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 Stasis, Deep Vein Thrombosis
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound.
- Trial name
- NCT03420625
- Testing
- Foot IPC, Rapid calf IPC, Slow calf IPC
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Karolinska University Hospital
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.
Varicose Veins, Venous Stasis
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins…
- Conditions
- Varicose Veins, Venous Stasis, Venous Insufficiency
- Trial name
- DESIVI (NCT03850496)
- Testing
- Revitive IX Neuromuscular Stimulation Device
- Volunteers
- 76 people
- Sponsor
- Imperial College London
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
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, 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