Clinical trials: Chronic Leg Ulcer
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Diabetic Foot Ulcer, Lower Extremity Wound
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
- Trial name
- NCT03044132
- Testing
- DermACELL AWM
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- LifeNet Health
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Neuropathic Diabetic Ulcer - Foot
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
- Trial name
- NCT01396837
- Testing
- RedDress Wound Care System (RD1)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.
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, Leg Injuries and Disorders
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers…
- Trial name
- CLEANVLU (NCT04956900)
- Testing
- Aurase Wound gel
- Where
- 8 sites in United States, Hungary and 1 more
- Volunteers
- 43 people
- Sponsor
- SolasCure Limited
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
Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
- Trial name
- NCT07219004
- Testing
- amniotic membrane
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tides Medical
Venous Leg Ulcers
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
- Trial name
- NOVEL2 (NCT01199588)
- Testing
- Nexagon® Low Dose, Nexagon® High Dose, Nexagon® Vehicle
- Where
- 34 sites in United States, Australia and 2 more
- Volunteers
- 300 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Venous Leg Ulcer
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
- Trial name
- VIEW-VLU (NCT03257254)
- Testing
- Varithena
- Where
- 14 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Boston Scientific Corporation
Diabetic Foot Ulcer
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be…
- Trial name
- NCT02209662
- Testing
- APIC-PRP
- Volunteers
- 274 people
- Sponsor
- Cytonics Corporation
Chronic Ulcer of Leg or Foot, Pressure Injury
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
- Trial name
- MORGEN (NCT05632250)
- Testing
- ConvaFoam
- Where
- 5 sites in United States
- Volunteers
- 95 people
- Sponsor
- ConvaTec Inc.
Partial Thickness Wound, Pressure Ulcer
The RESPOND Registry
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer
- Trial name
- RESPOND (NCT03286452)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- 15 sites in United States
- Volunteers
- 310 people
- Sponsor
- Organogenesis
Diabetic Foot, Chronic Ulcer
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
- Trial name
- NCT04185558
- Testing
- ActiGraft, Standard of Care
- Where
- 16 sites in United States, South Africa and 1 more
- Volunteers
- 119 people
- Sponsor
- RedDress Ltd.
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Diabetic Foot Ulcer, Diabetic Foot Infection
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.
- Trial name
- NM2023 (NCT06667752)
- Testing
- Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra
- Where
- 11 sites in Estonia, Spain
- Volunteers
- 136 people
- Sponsor
- Nanordica Medical OU