Clinical trials: Venous Leg Ulcers
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 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
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
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
Ulcer, Venous Ulcer
The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study
Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity.
- Conditions
- Ulcer, Venous Ulcer, Skin Ulcer, Leg Ulcer
- Trial name
- NCT01770509
- Testing
- NMBM, Compression garments
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- M.D. Lederman Consulting Ltd
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Venous Wound Ulcers
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
- Trial name
- Sorbion (NCT03020446)
- Testing
- Sorbion Dressing
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Toledo Health Science Campus
Trophic Ulcers, Chronic Venous Insufficiency
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device.
- Trial name
- NCT03104985
- Testing
- LASMIK, Conventional therapy
- Where
- Russia
- Volunteers
- 68 people
- Sponsor
- Research Center Matrix
Venous Leg Ulcer
Low Dose Aspirin for Venous Leg Ulcers
Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients.
- Trial name
- Aspirin4VLU (NCT02158806)
- Testing
- Aspirin
- Volunteers
- 251 people
- Sponsor
- University of Auckland, New Zealand
Venous Leg Ulcer
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
- Trial name
- NCT03077165
- Testing
- S42909 100 mg, S42909 200 mg, S42909 400 mg
- Where
- 80 sites in United States, Argentina and 9 more
- Volunteers
- 121 people
- Sponsor
- Ilkos Therapeutic Inc.
Lower Extremity Wound Infected, Venous Stasis Ulcers
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in…
- Trial name
- NCT02009501
- Testing
- VAC VeraFlo with Dakins Instillation, VAC Ulta Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Leg Ulcers
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
- Trial name
- NCT00627094
- Testing
- Biatain, Biatain Ibu
- Where
- 13 sites in Denmark, France and 2 more
- Volunteers
- 120 people
- Sponsor
- Coloplast A/S
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 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 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 Ulcer
Flexitouch Treatment for Venous Ulcers
This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers.
- Trial name
- NCT00847002
- Testing
- Standard Wound Care, Flexitouch System with Standard Wound Care
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tactile Systems Technology, Inc.
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 Ulcers, Mixed Leg Ulcers
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs.
- Trial name
- NCT01036438
- Testing
- Mepilex Ag, Mepilex without Ag
- Where
- 44 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Molnlycke Health Care AB
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