Clinical trials: Varicose Ulcer
Venous Leg Ulcer
A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer
This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU).
- Trial name
- NCT04078555
- Testing
- ENERGI-F703 GEL, ENERGI-F703 GEL matched vehicle
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Energenesis Biomedical Co., Ltd.
Venous Leg Ulcer
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.
- Trial name
- NCT04823962
- Testing
- rhGM-CSF + hydrogel, Standard care
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Reponex Pharmaceuticals A/S
Diabetic Foot Ulcer, Venous Leg Ulcer
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal…
- Trial name
- NCT06453187
- Testing
- Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers, AmnioExcel Plus for Venous Leg Ulcers
- Where
- 13 sites in United States
- Volunteers
- 350 people
- Sponsor
- Integra LifeSciences Corporation
Venous Thromboses, Venous Stasis
Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow
This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device.
- Trial name
- NCT05087108
- Testing
- OsciPulse system, Reference Therapy 1, Refence Therapy 2
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- OsciFlex LLC
Venous Leg Ulcer
HM242-Solution vs Comparator
The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing.
- Trial name
- NCT04902612
- Testing
- HM242-Solution, Saline
- Where
- 2 sites in Italy
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Wounds and Injuries
Managing Wounds With Allevyn Life in a Home Health Care Environment
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care.
- Trial name
- NCT02776800
- Testing
- Allevyn Life, Foam dressing with an integrated adhesive border
- Where
- 3 sites in United States
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete…
- Trial name
- NCT03818828
- Testing
- TTAX01, Profore Compression Therapy, Cadexomer Iodine dressing
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- BioTissue Holdings, Inc
Venous Ulcers
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
- Trial name
- NCT00545298
- Testing
- Nitric Oxide - same dose 6 wks, Nitric Oxide modified treatment
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nitric BioTherapeutics, Inc
Venous Leg Ulcer
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers.
- Trial name
- NCT05549609
- Testing
- XSTEM-VLU, Vehicle
- Where
- 2 sites in Sweden
- Volunteers
- 6 people
- Sponsor
- Xintela AB
Ulcer, Venous Ulcer
ECM and Blood Components for Wound Healing
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound…
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Trial name
- NCT01909908
- Testing
- ECM, Blood Products, ECM in Blood Products
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
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.
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
Venous Ulcer
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed.
- Trial name
- XCell (NCT00446823)
- Testing
- XCell cellulose wound dressing, Impregnated gauze dressing
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Xylos Corporation
Venous Leg Ulcer
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
- Trial name
- HEAL I (NCT03544788)
- Testing
- Cirvo™ Therapy
- Where
- United States
- Sponsor
- Radial Medical, Inc.
Venous Leg, Venous Leg Ulcer (VLU)
Evaluating the Durability of Closure for Venous Leg Ulcers
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
- Conditions
- Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer, Venous Ulcer
- Trial name
- THORSDOTTIR (NCT06697925)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Kerecis Ltd.
Non-healing Wound
Treatment of Wounds Using Oasis® ECM
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
- Trial name
- NCT03632031
- Testing
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Where
- 2 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- Cook Biotech Incorporated
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent)…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05489588
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 24 sites in United States
- Volunteers
- 165 people
- Sponsor
- W.L.Gore & Associates
Venous Leg Ulcer
Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers.
- Trial name
- FREEDOM (NCT04613687)
- Testing
- Compression bandage
- Volunteers
- 52 people
- Sponsor
- Laboratoires URGO
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.