The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
Infection of a diabetic foot ulcer (DFU) is a serious and common complication of diabetes and is among the most common diabetes-related cause of hospitalization and the leading cause of diabetes-associated lower limb amputation. The effectiveness of various systemic antibiotics, particularly the fluoroquinolones, in treating infected DFUs has been demonstrated. An alternative or adjunct to systemic antibiotic treatment of infected DFU's is topical antibiotic treatment. Topical treatment would have the advantages of avoiding systemic adverse effects, providing increased target site concentration, and allowing the use of antibiotics not approved for systemic treatment. AppliGel-G is a topically applied hydrogel formulation of gentamicin sulfate (GMS). Once in place the product remains in contact with the wound bed and releases Gentamicin to the wound bed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Georgetown University Hospital Center
Washington D.C., District of Columbia, United States
Florida Medical Center & Research, Inc.
Miami, Florida, United States
GF Professional Research, Corp.
Miami Lakes, Florida, United States
Advanced Foot and Ankle Institute of Georgia LLC
Smyrna, Georgia, United States
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
Time frame: 28 days
Incidence of infection cleared
Incidence of infection cleared at Day 14
Time frame: 28 days
DFU Volume % Change
percent change in DFU volume, measured weekly and compared to baseline
Time frame: 28 days
DFU Area % Change
percent change in DFU area, measured weekly and compared to baseline
Time frame: 28 days
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Union Memorial Hospital
Baltimore, Maryland, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States
Utah Valley Medical Center
Provo, Utah, United States