Clinical trials: Venous Stasis Ulcers
Chronic Ulcer, Venous Ulcer
Efficacy of PICO Single-use System in Chronic Ulcers
A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.
- Conditions
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
- Trial name
- NCT05877378
- Testing
- Single-use negative pressure therapy (PICO)
- Where
- Spain
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha
Incompetent Perforating Veins
Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins
This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.
- Trial name
- PESIV (NCT04686097)
- Testing
- treatment: puncture of coagulation, treatment: sclerosing agent injected
- Where
- 5 sites in China
- Volunteers
- 84 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Ulcer
Community RCT of the Effectiveness of Two Compression Bandaging Technologies
Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed…
- Trial name
- NCT00202267
- Testing
- Four-layer Bandage (Elastomeric), Short-stretch Bandage (Non-elastomeric)
- Where
- 15 sites in Canada
- Volunteers
- 426 people
- Sponsor
- Queen's University
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
Varicose Ulcer
Fat Grafting in Reducing Recurrence in Patients With Healed Venous Ulcers A Prospective Randomised Clinical Pilot Study
In this study, investigators aim to use fat grafting in patients with previously healed venous ulcers to study its role on increasing skin thickness and reconstructing skin layers which was damaged by venous hypertension and…
- Trial name
- NCT05239416
- Testing
- Fat grafting
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- National University of Ireland, Galway, Ireland
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
Varicose Ulcer
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months.
- Trial name
- NCT00656383
- Testing
- Clients randomized to nurse-led clinic, Clients receive leg ulcer care in their homes
- Where
- 2 sites in Canada
- Volunteers
- 401 people
- Sponsor
- Queen's University
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 Ulcer, Venous Ulcer of Leg
Venous Ulcers and Hyaluronic Acid Phonophoresis
Venous leg ulcers are severe manifestations of chronic venous insufficiency and account for a large proportion of lower limb ulcers.
- Trial name
- NCT07626203
- Testing
- Phonophoresis group (A), Ultrasound-preceded gel (hyaluronic acid gel) group (B):
- Where
- Egypt
- Volunteers
- 64 people
- Sponsor
- Cairo University
Venous Leg Ulcer, Social Interaction
The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes
Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic.
- Trial name
- legclub (NCT04370106)
- Testing
- Social leg program
- Where
- 2 sites in Switzerland
- Volunteers
- 268 people
- Sponsor
- School of Health Sciences Geneva
Inflammation, Veins
The Role of Pyroptosis in Chronic Venous Disease
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria.
- Conditions
- Inflammation, Veins, Complication, Varicose Veins
- Trial name
- PYROCVD (NCT03744858)
- Testing
- Peripheral blood draw
- Where
- Italy
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
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.
Venous Leg Ulcer, Chronic Non-Healing Cutaneous Wounds
LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults
This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Chronic Non-Healing Cutaneous Wounds, VLU
- Trial name
- NCT07463365
- Testing
- LUT017 gel
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Antoni Ribas