Clinical Trials Logo
  1. Home
  2. Critical Limb Ischemia
  3. NCT01410331

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:
A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection to Cohorts of Adults With Critical Limb Ischemia

Clinical Trial Summary

This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).

Clinical Trial Description

48 subjects diagnosed with Rutherford Class 4-5 Critical Limb Ischemia (CLI) with non-healing ulcers and/or ischemic rest pain will be enrolled in this study designed to investigate the safety and efficacy of JVS-100. JVS-100 will be delivered by direct intramuscular injection into the limbs of study subjects. Subjects will be randomized to receive a single set of direct intramuscular injections of either JVS-100 or vehicle control and will be followed for 12 months post dosing. Safety and efficacy assessments will be collected at 3 days, 4 weeks and 3, 6 and 12 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01410331
Study type Interventional
Source Juventas Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 2012
Completion date July 2014
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03668353 - Recombinant SeV-hFGF2/dF Injection for PAOD Phase 1
Recruiting NCT04110964 - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT Phase 1
Not yet recruiting NCT03994666 - Cell Therapy in Critical Limb Ischemia Phase 2
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Not yet recruiting NCT02498080 - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia N/A
Recruiting NCT02239419 - Evaluation of Carbothera in the Treatment of Foot Ulcers N/A
Recruiting NCT01938872 - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia N/A
Active, not recruiting NCT01211925 - Distal Venous Arterialisation of Ischemic Limb Phase 2/Phase 3
Completed NCT02454231 - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Phase 2/Phase 3
Completed NCT01758874 - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Phase 2
Completed NCT02475200 - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting NCT04583436 - Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia N/A
Completed NCT04071782 - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore N/A
Completed NCT03669458 - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. N/A
Not yet recruiting NCT06007469 - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting NCT04110327 - An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed NCT02260622 - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia Phase 2
Recruiting NCT02054416 - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality N/A