Clinical trials: Ulcer Venous
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 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 Stasis Ulcer, Venous Leg Ulcer
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional…
- Trial name
- NCT04647240
- Testing
- MTX-001 (human amniotic fluid)
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Merakris Therapeutics
Chronic Wound
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.
- Trial name
- NCT01429519
- Testing
- RPh201, botanical drug product
- Where
- Israel
- Volunteers
- 4 people
- Sponsor
- Regenera Pharma Ltd
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Venous Leg Ulcer, Leg Ulcer
Efficacy Study for Geko Device in VLU Patients (Canada)
The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go…
- Conditions
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- Trial name
- NCT05057793
- Testing
- geko
- Where
- 3 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Firstkind Ltd
Chronic Venous Insufficiency
Tissue Engineered Veins in Patients With Chronic Venous Insufficiency
This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in…
- Trial name
- TECVI-1 (NCT03784131)
- Testing
- P-TEV
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Verigraft AB
Venous Leg Ulcers
Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs).
- Trial name
- NCT07510412
- Testing
- NuShield®
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Venous Leg Ulcer
Assessment of the Evolution of Wound Biomarkers in Venous Leg Ulcers Treated With KLOX Biophotonic System
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU).
- Trial name
- NCT03593369
- Testing
- KLOX BioPhotonic System (single treatment)+SOC, KLOX BioPhotonic System (consecutive treatments)+SOC, Standard of Care (SOC)
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- KLOX Technologies 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 Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
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
Hard-to-heal Wounds, Diabetic Foot Ulcer
Clinical Investigation of Sorbact® Dressings
The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
- Conditions
- Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT05089890
- Testing
- Sorbact® Compress, Sorbact® Gel Dressing, Sorbact® Ribbon Gauze
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- ABIGO Medical AB
Venous Leg Ulcer
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised.
- Trial name
- PD-497314 (NCT02921750)
- Testing
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Where
- 33 sites in Czechia, Denmark and 4 more
- Volunteers
- 248 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Foot Ulcer Chronic, Skin Ulcer Venous Stasis Chronic
Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery.
- Conditions
- Foot Ulcer Chronic, Skin Ulcer Venous Stasis Chronic, Pressure Ulcer
- Trial name
- NCT02307448
- Testing
- Platelet Rich Plasma, Standard of Care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ACR Biologics, LLC
Venous Leg Ulcer (VLU)
Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU).
- Trial name
- NCT07268482
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Venous Insufficiency
Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
The purpose of this study is to prove the safety and efficacy of plasma as an add-on treatment in combination with conventional treatment in cases of chronical venous Ulcus cruris.
- Trial name
- NCT01415622
- Testing
- PlasmaDerm, standard care of Ulcera crurum
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Cinogy GmbH
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Venous Leg Ulcers
Comparison of Human Allograft to Apligraf for Venous Leg Ulcers
Given the propensity for venous leg ulcers to become refractory, long standing lesions, incorporating active biologic grafts into the standard compression therapy, has shown to accelerate wound healing.
- Trial name
- NCT02047084
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Solsys Medical LLC