Clinical trials: Ulcer, Leg
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, 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.
Sickle Cell Disease, Leg Ulcers
Resolution of Sickle Cell Leg Ulcers With Voxelotor
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease.
- Trial name
- RESOLVE (NCT05561140)
- Testing
- Voxelotor Oral Tablet
- Where
- 23 sites in Brazil, Kenya and 1 more
- Volunteers
- 88 people
- Sponsor
- Pfizer
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
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Pressure Ulcer, Leg Ulcer
Evaluation Of An Advanced Borderless Dressing
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03146845
- Testing
- ALLEVYN Life Non-Bordered, Standard Care
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.
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
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Chronic Wound, Venous Leg Ulcer
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03662997
- Testing
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Molnlycke Health Care AB