Clinical trials: Leg Ulcers Venous
Venous Insufficiency, Leg Ulcer
The Evaluation of OrCel for the Treatment of Venous Ulcers
This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone.
- Trial name
- NCT00270972
- Testing
- Bilayered Cellular Matrix (OrCel)
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Ortec International
Leg Ulcers
Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
- Trial name
- NCT02583958
- Testing
- Urgo 3103166, Aquacel Extra
- Where
- France
- Sponsor
- Laboratoires URGO
Venous Ulcers
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.
- Trial name
- NCT00613808
- Testing
- Nitric Oxide 200ppm Group B
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Nitric BioTherapeutics, Inc
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
Venous Leg Ulcer
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
- Trial name
- NCT06489028
- Testing
- allo-APZ2-CVU
- Where
- 15 sites in United States, Austria and 10 more
- Volunteers
- 250 people
- Sponsor
- RHEACELL GmbH & Co. KG
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 Ulcers
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers…
- Trial name
- NCT01743053
- Testing
- Standard Care plus ReCell, Standard Care
- Where
- 7 sites in France, United Kingdom
- Volunteers
- 52 people
- Sponsor
- Avita Medical
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 (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
Wound Healing, Diabetic Foot
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
- Conditions
- Wound Healing, Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer
- Trial name
- NCT06640985
- Testing
- EDX110 wound dressing system
- Where
- Chile
- Volunteers
- 43 people
- Sponsor
- ConvaTec 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.
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Chronic Ulcer of Lower Extremity
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
- Trial name
- NCT04667416
- Testing
- PalinGen Flow Amniotic Tissue Allograft
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- Amnio Technology, LLC
Pressure Injury, Venous Ulcer
MicroMatrix® Flex in Tunneling Wounds
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers
- Trial name
- NCT06629506
- Testing
- MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Wound Infection, Wound Heal
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a…
- Trial name
- INDICATE (NCT04979637)
- Sponsor
- ConvaTec Inc.
Impaired Wound Healing
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
- Trial name
- NCT02248077
- Testing
- AutoloGel, Usual and Customary Care (UCC)
- Sponsor
- Cytomedix
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous…
- Trial name
- NCT02015221
- Testing
- Dual Action Pneumatic Compression Device, Standard Compression Garments
- Where
- 11 sites in United States
- Volunteers
- 81 people
- Sponsor
- Tactile Medical
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Wounds
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services.
- Trial name
- NCT01113307
- Testing
- Activated allogeneic white blood cells
- Where
- 7 sites in Israel
- Volunteers
- 131 people
- Sponsor
- Macrocure Ltd.