Skin Ulcer News - LARVOL Sigma

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22 Mechanisms of Action

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|||||||||| Enrollment open: Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders (clinicaltrials.gov) - May 2, 2014
P1, N=44, Recruiting, Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Active, not recruiting --> Recruiting

|||||||||| Enrollment change: Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders (clinicaltrials.gov) - May 2, 2014
P1, N=23, Active, not recruiting, Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Active, not recruiting --> Recruiting N=18 --> 23

|||||||||| Trial completion: A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE) (clinicaltrials.gov) - Apr 28, 2014
P2, N=168, Completed, Sponsor: CoDa Therapeutics Inc.
N=18 --> 23 Recruiting --> Completed

|||||||||| Trial completion: NOVEL2: A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (clinicaltrials.gov) - Apr 28, 2014
P2, N=300, Completed, Sponsor: CoDa Therapeutics Inc.
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P4 trial: A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds (clinicaltrials.gov) - Apr 21, 2014
P4, N=60, Not yet recruiting, Sponsor: Liventa Bioscience

|||||||||| Clinical protocol, New P2 trial: Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers (clinicaltrials.gov) - Apr 20, 2014
P2, N=25, Recruiting, Sponsor: PluroGen Therapeutics, Inc

|||||||||| Enrollment closed: Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers (clinicaltrials.gov) - Apr 17, 2014
P3, N=440, Active, not recruiting, Sponsor: Healthpoint
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| New P4 trial: C H R O N O S: Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis (clinicaltrials.gov) - Apr 14, 2014
P4, N=40, Completed, Sponsor: Tourcoing Hospital

|||||||||| Clinical data, New P4 trial: Santyl Applications to Diabetic Foot Ulcers (clinicaltrials.gov) - Apr 9, 2014
P4, N=200, Not yet recruiting, Sponsor: Smith & Nephew, Inc.

|||||||||| Enrollment change: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers (clinicaltrials.gov) - Apr 7, 2014
P=N/A, N=19, Completed, Sponsor: University of Virginia
Recruiting --> Active, not recruiting N=40 --> 19

|||||||||| Trial completion: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers (clinicaltrials.gov) - Apr 7, 2014
P=N/A, N=19, Completed, Sponsor: University of Virginia
N=40 --> 19 Recruiting --> Completed

|||||||||| Trial completion: DIAPLIQ: Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot (clinicaltrials.gov) - Apr 7, 2014
P=N/A, N=20, Completed, Sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Recruiting --> Completed Recruiting --> Completed

|||||||||| Enrollment change: A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy (clinicaltrials.gov) - Apr 6, 2014
P=N/A, N=47, Active, not recruiting, Sponsor: AO Clinical Investigation and Documentation
Recruiting --> Completed N=30 --> 47

||||||||||  Grafix (cryopreserved placental membrane) / Osiris
Enrollment change:  Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers (clinicaltrials.gov) -  Apr 6, 2014
P4, N=97, Completed,  Sponsor: Osiris Therapeutics
N=30 --> 47 N=266 --> 97

|||||||||| Enrollment closed: A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy (clinicaltrials.gov) - Apr 6, 2014
P=N/A, N=47, Active, not recruiting, Sponsor: AO Clinical Investigation and Documentation
N=266 --> 97 Not yet recruiting --> Active, not recruiting

||||||||||  Grafix (cryopreserved placental membrane) / Osiris
Trial completion:  Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers (clinicaltrials.gov) -  Apr 6, 2014
P4, N=97, Completed,  Sponsor: Osiris Therapeutics
Not yet recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Trial termination: Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers (clinicaltrials.gov) - Apr 6, 2014
P=N/A, N=13, Terminated, Sponsor: Erchonia Corporation
Active, not recruiting --> Completed Recruiting --> Terminated; recruitment difficulties

|||||||||| Enrollment change: Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers (clinicaltrials.gov) - Apr 6, 2014
P=N/A, N=13, Terminated, Sponsor: Erchonia Corporation
Recruiting --> Terminated; recruitment difficulties N=80 --> 13

||||||||||  Januvia (sitagliptin) / Merck (MSD)
Enrollment open:  Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers (clinicaltrials.gov) -  Apr 6, 2014
P2, N=250, Recruiting,  Sponsor: Georgetown University
N=80 --> 13 Not yet recruiting --> Recruiting

|||||||||| Trial termination: August2: Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia (clinicaltrials.gov) - Apr 3, 2014
P3, N=34, Terminated, Sponsor: GWT-TUD GmbH
Not yet recruiting --> Recruiting Recruiting --> Terminated; recruition number was not reached

|||||||||| Enrollment change: August2: Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia (clinicaltrials.gov) - Apr 3, 2014
P3, N=34, Terminated, Sponsor: GWT-TUD GmbH
Recruiting --> Terminated; recruition number was not reached N=211 --> 34

|||||||||| Trial completion: Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer (clinicaltrials.gov) - Apr 3, 2014
P=N/A, N=30, Completed, Sponsor: Seoul National University Hospital
N=211 --> 34 Recruiting --> Completed

|||||||||| Trial termination: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia (clinicaltrials.gov) - Apr 3, 2014
P=N/A, N=123, Terminated, Sponsor: GWT-TUD GmbH
Recruiting --> Completed Recruiting --> Terminated; recrution number was not reached

|||||||||| Enrollment change: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia (clinicaltrials.gov) - Apr 3, 2014
P=N/A, N=123, Terminated, Sponsor: GWT-TUD GmbH
Recruiting --> Terminated; recrution number was not reached N=211 --> 123

||||||||||  cefazolin / Generic mfg.
Trial initiation date:  DAD: Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion (clinicaltrials.gov) -  Mar 31, 2014
P1, N=0, Available,  Sponsor: Silberg, Barry N., M.D.
N=211 --> 123 Initiation date: Mar 2008 --> Jan 2014

|||||||||| Clinical: Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds (clinicaltrials.gov) - Mar 26, 2014
P=N/A, N=20, Recruiting, Sponsor: Medical University of Vienna

||||||||||  chlorhexidine gluconate / Generic mfg.
New P4 trial:  Diabetic Foot Ulcer. Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water (clinicaltrials.gov) -  Mar 25, 2014
P4, N=80, Not yet recruiting,  Sponsor: Universidad de Guanajuato

|||||||||| Trial termination: The Relationship of Hemoglobin A1c and Diabetic Wound Healing (clinicaltrials.gov) - Mar 25, 2014
P4, N=2, Terminated, Sponsor: Susan Hassenbein
Initiation date: Mar 2008 --> Jan 2014 Enrolling by invitation --> Terminated; study closed due to recruitment problems

|||||||||| Enrollment change: The Relationship of Hemoglobin A1c and Diabetic Wound Healing (clinicaltrials.gov) - Mar 25, 2014
P4, N=2, Terminated, Sponsor: Susan Hassenbein
Enrolling by invitation --> Terminated; study closed due to recruitment problems N=40 --> 2

|||||||||| Clinical: CHEXU 01: Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended. (clinicaltrials.gov) - Mar 17, 2014
P=N/A, N=25, Not yet recruiting, Sponsor: Molnlycke Health Care AB

|||||||||| Clinical protocol, New P2 trial: Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers (clinicaltrials.gov) - Mar 17, 2014
P2, N=50, Recruiting, Sponsor: PluroGen Therapeutics, Inc

|||||||||| Enrollment open: Use of dHACM in the Treatment of Venous Leg Ulcers (clinicaltrials.gov) - Mar 12, 2014
P=N/A, N=90, Recruiting, Sponsor: MiMedx Group, Inc.
N=40 --> 2 Not yet recruiting --> Recruiting

|||||||||| Trial completion: Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study (clinicaltrials.gov) - Mar 2, 2014
P=N/A, N=19, Completed, Sponsor: Zurich University of Applied Sciences
Not yet recruiting --> Recruiting Recruiting --> Completed

|||||||||| Trial termination: The AutoloGel™ Post-Market Surveillance (TAPS) Program (clinicaltrials.gov) - Feb 24, 2014
P=N/A, N=131, Terminated, Sponsor: Cytomedix
Recruiting --> Completed Recruiting --> Terminated; Discontinued due to favorable results

|||||||||| Enrollment change: The AutoloGel™ Post-Market Surveillance (TAPS) Program (clinicaltrials.gov) - Feb 24, 2014
P=N/A, N=131, Terminated, Sponsor: Cytomedix
Recruiting --> Terminated; Discontinued due to favorable results N=300 --> 131

|||||||||| Trial completion, Gene therapy: Gene Therapy to Improve Wound Healing in Patients With Diabetes (clinicaltrials.gov) - Feb 22, 2014
P1, N=21, Completed, Sponsor: Tissue Repair Company
N=300 --> 131 No longer recruiting --> Completed

|||||||||| Trial completion: A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk (clinicaltrials.gov) - Feb 19, 2014
P2, N=750, Completed, Sponsor: Department of Veterans Affairs
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing (clinicaltrials.gov) - Feb 19, 2014
P2, N=120, Completed, Sponsor: Department of Veterans Affairs
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 (clinicaltrials.gov) - Feb 19, 2014
P2, N=427, Completed, Sponsor: Department of Veterans Affairs
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: Bioengineered Skin and Wound Healing (clinicaltrials.gov) - Feb 19, 2014
P1, N=50, Completed, Sponsor: Roger Williams Medical Center
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Enrollment closed: Cell Therapy for Venous Leg Ulcers Pilot Study (clinicaltrials.gov) - Feb 19, 2014
P1, N=4, Active, not recruiting, Sponsor: Hospital de Clínicas Dr. Manuel Quintela
No longer recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment open: MxT Ag 05: TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended (clinicaltrials.gov) - Feb 18, 2014
P4, N=30, Recruiting, Sponsor: Molnlycke Health Care AB
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders (clinicaltrials.gov) - Feb 6, 2014
P1, N=23, Active, not recruiting, Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Not yet recruiting --> Recruiting Completed --> Active, not recruiting

|||||||||| Trial completion: A Pilot Study to Assess the DynaSense System (clinicaltrials.gov) - Feb 3, 2014
P=N/A, N=70, Completed, Sponsor: Leaf Healthcare, Inc.
Completed --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Enrollment open: Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers (clinicaltrials.gov) - Jan 29, 2014
P2, N=50, Recruiting, Sponsor: Professor Stewart Walsh
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment open: Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (clinicaltrials.gov) - Jan 26, 2014
P3, N=440, Recruiting, Sponsor: Smith & Nephew, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment open: ORTHODIAB: Evaluation of a New Device "Orth (clinicaltrials.gov) - Jan 23, 2014
P=N/A, N=110, Recruiting, Sponsor: Proteor Group
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Trial completion: Efficacy of Prontosan Solution on Chronic Ulcers (clinicaltrials.gov) - Jan 13, 2014
P3, N=289, Completed, Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

||||||||||  gentamicin sulfate / Generic mfg.
New P1/2 trial:  Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers (clinicaltrials.gov) -  Jan 13, 2014
P1/2, N=86, Recruiting,  Sponsor: Royer Biomedical, Inc.

|||||||||| Enrollment open: The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY (clinicaltrials.gov) - Jan 12, 2014
P=N/A, N=500, Recruiting, Sponsor: Gulhane Military Medical Academy
Not yet recruiting --> Completed Not yet recruiting --> Recruiting