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Clinical Trial Details

Trial ID: L6424
Source ID: NCT02036528
Associated Drug: Gentamicin Topical Gel
Title: Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetic Foot Ulcers
Interventions: DRUG: Gentamicin Topical Gel|DRUG: Ciprofloxacin|DRUG: Doxycycline
Outcome Measures: Primary: Complete wound clearing of infection, Proportion of subjects with foot ulcer infection completely cleared at or by 28 days of AppliGel-G treatment compared to proportion of subjects with foot ulcer infection completely cleared at or by 28 days of control treatment, 28 days | Secondary: Incidence of infection cleared, Incidence of infection cleared at Day 14, 28 days|DFU Volume % Change, percent change in DFU volume, measured weekly and compared to baseline, 28 days|DFU Area % Change, percent change in DFU area, measured weekly and compared to baseline, 28 days
Sponsor/Collaborators: Sponsor: Royer Biomedical, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01
Completion Date:
Results First Posted:
Last Update Posted: 2015-05-14
Locations: Georgetown University Hospital Center, Washington, District of Columbia, 20007, United States|GF Professional Research, Corp., Miami Lakes, Florida, 33016, United States|Florida Medical Center & Research, Inc., Miami, Florida, 33142, United States|Advanced Foot and Ankle Institute of Georgia LLC, Smyrna, Georgia, 30080, United States|Union Memorial Hospital, Baltimore, Maryland, 21218, United States|Detroit Clinical Research Center, PC, Farmington Hills, Michigan, 48334, United States|Utah Valley Medical Center, Provo, Utah, 84604, United States
URL: https://clinicaltrials.gov/show/NCT02036528

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D152 Ciprofloxacin small molecule DB00537 Details
D066 Doxycycline small molecule DB00254 Details