Diabetic Foot Ulcers Clinical Trial
Official title:
A Phase I/II, Open Label, Controlled Study to Evaluate the Safety and Efficacy of AppliGel-G [Gentamicin Sulfate Topical Gel] for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers in Patients With Type 1 and Type 2 Diabetes
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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