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Bisphosphocin
Active for Foot Ulcer
Phase 2
Waitlist Available
Research Sponsored by Lakewood-Amedex Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women at least 18 years of age and up to 80 years of age, inclusive.
Voluntary written consent, given before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)
Eligible Conditions
- Foot Ulcer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0
Secondary outcome measures
To assess antimicrobial effects of Nu-3 Gel on cDFU wound microflora
To assess the clinical effects of Nu-3 Gel on the cDFU surface area as assessed using advanced digital imaging wound assessment post debridement
To support determination of the appropriate dose range of Nu-3 Gel to be employed in future clinical studies.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment2 Interventions
Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days
Group II: PlaceboPlacebo Group1 Intervention
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
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Who is running the clinical trial?
Lakewood-Amedex IncLead Sponsor
2 Previous Clinical Trials
91 Total Patients Enrolled
1 Trials studying Foot Ulcer
60 Patients Enrolled for Foot Ulcer
Professional Education and Research InstituteOTHER
12 Previous Clinical Trials
1,025 Total Patients Enrolled
11 Trials studying Foot Ulcer
996 Patients Enrolled for Foot Ulcer
PrimeVigilanceIndustry Sponsor
5 Previous Clinical Trials
287 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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