Clinical trials: Vein Injury
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.
Venous Stasis Ulcers
Wound Fluid Protease Levels During Use of Novel Wound Dressing
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing.
- Trial name
- NCT01567150
- Testing
- Novel Dressing
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Hollister Incorporated
Venous Leg Ulcer
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox…
- Trial name
- Granulox01 (NCT04181320)
- Testing
- Venous Leg Ulcer Standard of Care with Granulox
- Where
- 27 sites in Croatia, Czechia and 5 more
- Volunteers
- 128 people
- Sponsor
- Molnlycke Health Care AB
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
Venous Leg Ulcer
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and…
- Trial name
- NCT01153633
- Testing
- Prontosan Wound Irrigation Solution and Prontosan Wound Gel
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Ulcers, Wounds
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
- Trial name
- NCT00951080
- Testing
- Traditional NPWT System, SNaP Wound Care System
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- 3M
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.
Lower Leg Wound
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
- Trial name
- WoundWand (NCT01924806)
- Testing
- WoundWand™ Debridement Device, Standard of Care sharp debridement
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 11 people
- Sponsor
- Smith & Nephew, Inc.
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.
Catheter Occlusion, Thrombosis
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
To evaluate the efficacy and safety of CUSA-081 (diluted reteplase) in the restoration of central venous access device (CVAD) functionality in participants 18 years and older.
- Trial name
- READY1 (NCT03594175)
- Testing
- CUSA-081, Alteplase
- Where
- 77 sites in United States, Argentina and 5 more
- Volunteers
- 462 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Venous Leg Ulcer
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised.
- Trial name
- PD-497314 (NCT02921750)
- Testing
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Where
- 33 sites in Czechia, Denmark and 4 more
- Volunteers
- 248 people
- Sponsor
- Molnlycke Health Care AB
Venous Ulcer of Leg
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will…
- Trial name
- IGuideU (NCT04696354)
- Testing
- IVUS, Continued Compression Therapy/Stockings
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
OASIS Wound Matrix (Oasis) Mechanism of Action
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
- Trial name
- NCT00570141
- Testing
- OASIS Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Healthpoint
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
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 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.
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.