Clinical trials: Venous Leg Ulcers (VLU)
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
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, 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
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01737762
- Testing
- HP802-247, Vehicle
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 155 people
- Sponsor
- Healthpoint
Pathologic Processes, Diabetes Mellitus
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers…
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Trial name
- C5CAMP (NCT06674980)
- Testing
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- C5 Biomedical
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
Venous Leg Ulcer
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle…
- Trial name
- NCT01658618
- Testing
- HP802-247
- Where
- 49 sites in United States, Canada
- Volunteers
- 440 people
- Sponsor
- Healthpoint
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU
Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers
- Trial name
- NCT03999281
- Testing
- Human Allograft (Theraskin)
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- Solsys Medical LLC
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
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 (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
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
Efficacy and Safety of URGOBD001 Compression System
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous…
- Trial name
- FUTURE (NCT05158764)
- Testing
- Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification
- Where
- France
- Volunteers
- 178 people
- Sponsor
- Laboratoires URGO
Venous Leg Ulcer, Venous Stasis
SkinTE® in the Treatment of Venous Leg Wounds
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings…
- Conditions
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- Trial name
- NCT03881267
- Testing
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Application, Fibracol Wound Dressing
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- PolarityTE
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
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.
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
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Venous Leg Ulcer
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete…
- Trial name
- NCT03818828
- Testing
- TTAX01, Profore Compression Therapy, Cadexomer Iodine dressing
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- BioTissue Holdings, Inc