Who is sponsoring NCT00659646?

NCT00659646 is sponsored by Innocoll.

What condition does NCT00659646 study?

NCT00659646 studies Diabetic Foot Ulcer.

What drugs are being tested in NCT00659646?

Interventions: gentamicin-collagen sponge and levofloxacin, Levofloxacin only.

What is the status of NCT00659646?

NCT00659646 is currently COMPLETED.

Last reviewed 2022-01-25 · How we verify

A Randomized, Controlled, Open Label Study of the Safety and Efficacy of a Topical Gentamicin Collagen Sponge Combined With An Antibiotic Compared to Antibiotic Therapy Alone in Diabetic Patients With Moderately Infected Foot Ulcers

NCT00659646 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	Innocoll
Phase	Phase 2
Status	COMPLETED
Enrolment	56
Start date	2008-04
Completion	2010-02

Conditions

Diabetic Foot Ulcer

Interventions

gentamicin-collagen sponge and levofloxacin
Levofloxacin only

Primary outcomes

Number of Participants With a Clinical Cure at Visit 3 (Day 7) — Day 7 of treatment
Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.

Countries

United States