Clinical trials: Venous Leg Ulcers (VLU)
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 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
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.
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.
Venous Leg Ulcer (VLU)
Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.
- Trial name
- EVOLVE (NCT07230340)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Cellution Biologics
Ulcer Venous, Wound Heal
Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs .
- Trial name
- NCT06400875
- Testing
- InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
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
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
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcer (VLU)
OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.
The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound…
- Trial name
- NCT07754526
- Testing
- Omeza OCM™ Wound Matrix, Routine Care
- Where
- United States
- Volunteers
- 254 people
- Sponsor
- Omeza, LLC
Hard-to-heal Wounds, Venous Leg Ulcer (VLU)
Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults
The aim of this quasi-experimental prospective study is to evaluate the effectiveness of photobiomodulation treatment on hard-to-heal ulcers of various diagnosed aetiologies in frail older adults, admitted to municipal home…
- Conditions
- Hard-to-heal Wounds, Venous Leg Ulcer (VLU), Arterial Leg Ulcer, Pressure Ulcer (PU)
- Trial name
- NCT07520825
- Testing
- Photobiomodulation, Standard-of-care ulcer dressing
- Where
- Sweden
- Volunteers
- 1,290 people
- Sponsor
- Umeå University
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers
This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign.
- Trial name
- RESCUE-PATCH (NCT07048054)
- Testing
- TrophiPatch: allogeneic adipose-derived stromal cell patch
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- Nicolò Brembilla
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
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- Trial name
- CAMP RWE (NCT07046767)
- Testing
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap, IP2: BioLab Tri-Membrane Wrap
- Where
- 7 sites in United States
- Volunteers
- 165 people
- Sponsor
- Capsicure, LLC
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
Non-Diabetic Patients, Wound Leg
Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care.
- Conditions
- Non-Diabetic Patients, Wound Leg, Chronic Ulcer Leg/Foot
- Trial name
- miR210 (NCT02024243)
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Chandan Sen
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic…
- Trial name
- NCT07172893
- Testing
- DermaBind TL
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- HealthTech Wound Care
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