Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2018-06-19
2020-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dysport Dose 1
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Dysport Dose 2
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Placebo
Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
Placebo
Investigators will inject the reconstituted solution into foot muscles.
Interventions
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Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Placebo
Investigators will inject the reconstituted solution into foot muscles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Painful HAV in the study foot at Baseline
Exclusion Criteria
* Other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function
* Medical history or clinical evidence of any vascular disease and/or diabetic condition
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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NEA Baptist Clinic
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, United States
Center for Clinical Research Inc.
Castro Valley, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
Southwestern Academic Limb Salvage Alliance
Los Angeles, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
University Foot and Ankle Institute
Santa Monica, California, United States
Center for Spine and Orthopedics
Thornton, Colorado, United States
LCC Medical Research Institute
Miami, Florida, United States
Conquest Research
Orlando, Florida, United States
Doctors Research Network
South Miami, Florida, United States
Clinical Research
West Palm Beach, Florida, United States
Podiatry 1st
Belleville, Illinois, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, United States
Rosalind Franklin Clinic
North Chicago, Illinois, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, United States
The Chesapeake Research Group
Pasadena, Maryland, United States
Dr. Allen M. Jacobs and Associates
St Louis, Missouri, United States
Ankle and Foot Care Centers
Youngstown, Ohio, United States
Medical Research International
Oklahoma City, Oklahoma, United States
Foot and Ankle Center
Bryn Mawr, Pennsylvania, United States
Harrisburg Foot and Ankle Center, INC
Harrisburg, Pennsylvania, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Bio X Cell Research
San Antonio, Texas, United States
Texas Gulf Coast Medical Group
Webster, Texas, United States
Summit Foot & Ankle
Salt Lake City, Utah, United States
Harrisonburg Foot and Ankle Clinic
Harrisonburg, Virginia, United States
1Foot 2Foot Centre for Foot and Ankle Care, PC
Suffolk, Virginia, United States
Martinsville Research Institute, Inc.
Salem, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D-FR-52120-237
Identifier Type: -
Identifier Source: org_study_id
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