Clinical trials: Leg Ulcers Venous
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.
Chronic Wounds, Diabetes
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and wound improvement.
- Conditions
- Chronic Wounds, Diabetes, Venous Stasis Ulcers
- Trial name
- NCT00425178
- Testing
- FGF-1
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Venturis Therapeutics, Inc.
Varicose Ulcer
Cost Evaluation of Venous Leg Ulcers Management
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
- Trial name
- EPIC (NCT02728986)
- Testing
- Profore, Coban2
- Where
- France
- Volunteers
- 176 people
- Sponsor
- Solventum US LLC
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited
Diabetic Foot Ulcer, Venous Ulcer
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and…
- Trial name
- NCT00338923
- Testing
- HO/03/03
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- HealOr
Venous Ulcer
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months.
- Trial name
- NCT00820196
- Testing
- Nexagon®, Nexagon® vehicle
- Where
- 10 sites in United States, New Zealand
- Volunteers
- 98 people
- Sponsor
- OcuNexus Therapeutics, Inc.
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
Chronic Leg Ulcers, Wound Healing
Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing.
- Trial name
- NCT00825760
- Testing
- Topical PPA904 gel and light
- Where
- 4 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Photopharmica
Venous Leg Ulcer
Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients
Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources.
- Trial name
- NCT02912858
- Testing
- geko plus R-2
- Sponsor
- Firstkind Ltd
Burns, Trauma
Split Thickness Donor Site Healing With MIST Study
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility.
- Conditions
- Burns, Trauma, Venous Ulcers
- Trial name
- NCT01214980
- Testing
- MIST Therapy, Standard of care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Celleration, Inc.
Venous Leg Ulcer, Leg Injuries and Disorders
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers…
- Trial name
- CLEANVLU (NCT04956900)
- Testing
- Aurase Wound gel
- Where
- 8 sites in United States, Hungary and 1 more
- Volunteers
- 43 people
- Sponsor
- SolasCure Limited
Venus Leg Ulcers
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
The objectives of this study are: To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo…
- Trial name
- H2H (NCT06690177)
- Testing
- EscharEx (EX-03), Non-surgical standard of care (NSSOC)
- Where
- 2 sites in United States, Poland
- Volunteers
- 45 people
- Sponsor
- MediWound Ltd
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
Leg Ulcer
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to…
- Trial name
- NCT01591434
- Testing
- AQUACEL®, AQUACEL® Extra™
- Where
- 12 sites in Germany, Netherlands and 2 more
- Volunteers
- 65 people
- Sponsor
- ConvaTec Inc.
Wounds, Wound of Skin
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer
- Trial name
- NCT05608317
- Testing
- ALLEVYN Non-Adhesive
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer (VLU), Compression Bandages
A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France.
- Trial name
- NCT07600489
- Testing
- Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®), Wound Dressing Material
- Where
- 8 sites in France
- Volunteers
- 386 people
- Sponsor
- Molnlycke Health Care AB
Varicose Ulcer
A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
- Trial name
- NCT00648674
- Testing
- Apligraf
- Sponsor
- Organogenesis
Leg Ulcer, Electrical Remodeling
Electrostimulation System WoundEL for Leg Ulcers Healing (
Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing.
- Trial name
- ELEXICA (NCT04980898)
- Testing
- WoundEL medical device, Standard cares
- Where
- France
- Volunteers
- 22 people
- Sponsor
- CEN Biotech
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
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