Clinical trials: Venous Stasis Ulcer
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec 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
Venous Leg Ulcer, Venous Stasis Ulcer
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone.
- Trial name
- NCT00270946
- Testing
- Bilayered Cellular Matrix (OrCel)
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Ortec International
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05409976
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 136 people
- Sponsor
- W.L.Gore & Associates
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.
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
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
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
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Chronic Venous Hypertension With Ulcer
Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
- Trial name
- NCT03935386
- Testing
- Standard Multi-layered Compression dressing, Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Solsys Medical LLC
Venous Leg Ulcer
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
- Trial name
- NCT06544564
- Testing
- Membrane Wrap™, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- BioLab Holdings
Venous Leg Ulcer
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
- Trial name
- NCT07061613
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
Venous Leg Ulcer
PLASOMA Efficacy & Technology Health (PETH) Study
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.
- Trial name
- NCT04922463
- Testing
- PLASOMA
- Where
- 2 sites in Netherlands
- Volunteers
- 46 people
- Sponsor
- Plasmacure
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 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
Venous Leg Ulcer, Venous Ulcer
Tissue Repair Gel in Venous Leg Ulcers (US)
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis
- Trial name
- TRIVIA (NCT06707090)
- Testing
- TR987 0.1% gel + Standard of Care, Standard of care
- Where
- 33 sites in United States
- Volunteers
- 312 people
- Sponsor
- TR Therapeutics
Chronic Leg Ulcer, Venous Leg Ulcer
Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg…
- Trial name
- NCT05710094
- Testing
- SoftOx Biofilm Eradicator (Groups 1 to 7), Sterile isotonic saline (Groups 1 to 4)
- Where
- Denmark
- Volunteers
- 28 people
- Sponsor
- SoftOx Solutions AS
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