Clinical trials: Varicose Ulcers
Wound Care, Pressure Ulcer
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring
This study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with IDRT without burring or fenestration as a…
- Conditions
- Wound Care, Pressure Ulcer, Venous Ulcer, Surgical Wound
- Trial name
- NCT05311124
- Testing
- Integra Dermal Regeneration template (IDRT)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Joshua Choo
Leg Ulcers Venous, Leg Ulcer Arterial
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems.
- Conditions
- Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed
- Trial name
- NCT03112395
- Testing
- Pio Medical Device
- Where
- 3 sites in Switzerland
- Volunteers
- 36 people
- Sponsor
- Piomic Medical AG
Venous Leg Ulcer
DermaRep™ Device in the Treatment of Venous Leg Ulcers
This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish…
- Trial name
- DermaRep™ (NCT03699072)
- Testing
- DermaRep™ Wound Contact Device
- Where
- 6 sites in United Kingdom
- Volunteers
- 39 people
- Sponsor
- Biovotec AS
Diabetic Foot Ulcer, Venous Leg Ulcer
Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS
Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity.
- Trial name
- COSMAS (NCT07251426)
- Testing
- COLD ATMOSPHERIC PLASMA
- Volunteers
- 494 people
- Sponsor
- Olaf Bakker
Venous Ulcer
Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic…
- Trial name
- NCT05962931
- Testing
- Bioengineered Artificial Mesenchimal Sheet (BAMS), Standard treatment (Control)
- Where
- 3 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
Venous Leg Ulcer (VLU)
EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD
Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers…
- Trial name
- NCT07440797
- Testing
- Saline solution, Vashe solution
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Laboratoires URGO
Venous Leg Ulcer
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
- Trial name
- LTFU (NCT01891760)
- Testing
- Dermagraft, Profore
- Where
- 28 sites in United States, Estonia and 4 more
- Volunteers
- 225 people
- Sponsor
- Shire Regenerative Medicine, Inc.
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.
Vascular, DVT - Deep Vein Thrombosis
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually.
- Conditions
- Vascular, DVT - Deep Vein Thrombosis, Post Thrombotic Syndrome, Venous Ulcer of Leg
- Trial name
- NCT07762222
- Testing
- dedicated venous stenting, Dedicated venous stent / iliofemoral dedicated venous stenting
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Ain Shams University
Venous Ulcer
A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers
The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.
- Trial name
- NCT01327937
- Testing
- Apligraf, Standard of Care Dressing Group
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Organogenesis
Venous Leg Ulcer
Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT06930768
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Wounds, Wound of Skin
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Wound; Foot
- Trial name
- NCT05588583
- Testing
- Mepilex Up
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Molnlycke Health Care AB
Venous Ulcer
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
The purpose of this study is to investigate the functionality of a new type of wound monitoring method and measurement system for monitoring healing of venous ulcers.
- Trial name
- WoundWatch® (NCT05805137)
- Testing
- WoundWatch® wound monitoring system
- Where
- 2 sites in Finland, Poland
- Volunteers
- 20 people
- Sponsor
- CutoSense Oy
Venous Stasis Ulcers, Venous Insufficiency
Taliderm Dressing for Venous Ulcers
The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs.
- Trial name
- NCT00720239
- Testing
- Taliderm wound healing dressing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Medical University of South Carolina
Varicose Ulcer
Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.
The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers.
- Trial name
- NCT01449422
- Testing
- Dressing
- Where
- France
- Volunteers
- 159 people
- Sponsor
- Laboratoires URGO
Varicose Ulcer, Venous Insufficiency of Leg
Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency
This is a multicentre, quasi-experimental study to evaluate the Conformitè Europëenne-marked Compreflex standard calf and foot (with basic liner) under routine conditions.
- Trial name
- NCT05364112
- Testing
- Compreflex
- Where
- Malaysia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kuala Lumpur General Hospital
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Venous Leg Ulcer
Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice
The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006.
- Trial name
- INVICTUS (NCT03736941)
- Testing
- Patients with venous leg
- Where
- 2 sites in France
- Volunteers
- 129 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain
Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people.
- Trial name
- NCT01561170
- Testing
- Active Pulsed Electro-Magnetic Field (PEMF)
- Where
- Denmark
- Volunteers
- 36 people
- Sponsor
- Northern Orthopaedic Division, Denmark