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Regenerative Injection Therapy
Regenerative Injection Therapy for Plantar Fibroma
Phase 4
Waitlist Available
Research Sponsored by Réseau de Santé Vitalité Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 weeks from week 0 to 36
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
The purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.
Eligible Conditions
- Plantar Fibroma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 weeks from week 0 to 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks from week 0 to 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of pain and function of the affected foot during the course of treatment
Secondary study objectives
Assessment of pain intensity and pain-related function impairment during the course of treatment
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Regenerative Injection TherapyExperimental Treatment1 Intervention
Group II: ExerciseActive Control1 Intervention
Group III: Dry needlePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regenerative injection therapy
2007
Completed Phase 4
~50
Find a Location
Who is running the clinical trial?
Réseau de Santé Vitalité Health NetworkLead Sponsor
8 Previous Clinical Trials
1,883 Total Patients Enrolled
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