Clinical trials: Ulcer, Leg
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 Ulcers, Leg Ulcers Venous
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing.
- Trial name
- NCT07901517
- Testing
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- BTL Industries Ltd.
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT07538609
- Testing
- GORE® VIABAHN® FORTEGRA Venous Stent
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
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
Venous Leg Ulcer (VLU)
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
- Trial name
- VALUE (NCT06568627)
- Testing
- EscharEx (EX-03)
- Where
- 60 sites in United States, Austria and 7 more
- Volunteers
- 216 people
- Sponsor
- MediWound Ltd
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
- Conditions
- Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- NCT07078968
- Testing
- Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- BioLab Holdings
Diabetic Foot Ulcer, Foot Ulcer Chronic
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous…
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer Chronic, DFU, Ulcer Foot
- Trial name
- BIORESCUE (NCT07364630)
- Testing
- Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU, Membrane Wrap-Lite™ DFU
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- BioLab Holdings
Non-infected Venous Leg Ulcer, Venous Leg Ulcer
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux.
- Conditions
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis
- Trial name
- NCT06811909
- Testing
- BR-AC, Standard Care
- Where
- 22 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Venous Leg Ulcer, Venous Leg
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the…
- Conditions
- Venous Leg Ulcer, Venous Leg, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- NCT06826339
- Testing
- ACApatch™, caregraFT™, Standard of Care
- Where
- United States
- Volunteers
- 340 people
- Sponsor
- Tiger Biosciences, LLC.
Wound, Venous Leg Ulcer
Geko™ Cross Therapy Registry - Wound
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term…
- Conditions
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
- Trial name
- CTR-Wound (NCT05007301)
- Testing
- geko device
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 2,500 people
- Sponsor
- Firstkind Ltd
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 Ulcers (VLUs)
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs).
- Trial name
- ACHIEVE (NCT07152717)
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
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 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
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
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
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent)…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05489588
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 24 sites in United States
- Volunteers
- 165 people
- Sponsor
- W.L.Gore & Associates