Who is sponsoring NCT00593567?

NCT00593567 is sponsored by Innocoll.

What condition does NCT00593567 study?

NCT00593567 studies Diabetic Foot Ulcer.

What drugs are being tested in NCT00593567?

Interventions: gentamicin-collagen sponge, Levofloxacin.

What is the status of NCT00593567?

NCT00593567 is currently COMPLETED.

Last reviewed 2022-05-27 · How we verify

A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer

NCT00593567 Phase 2 COMPLETED Results posted

The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.

Details

Lead sponsor	Innocoll
Phase	Phase 2
Status	COMPLETED
Enrolment	70
Start date	2007-12
Completion	2009-05

Conditions

Diabetic Foot Ulcer

Interventions

gentamicin-collagen sponge
Levofloxacin

Primary outcomes

Number of Participants With a Clinical Outcome of "Clinical Cure" — Final Study Visit (Day 21 [or 28 or 35])
Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.

Countries

United States