Overview

Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Geneva
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Gentamicins
Criteria
Inclusion Criteria:

- Is aged ≥ 18.

- Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.

- Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located
on or below the malleolus that presents with the following clinical manifestations of
a moderate or severe infection based on the Infectious Disease Society of America
(IDSA).

- Has received appropriate surgical intervention to remove all necrotic and infected
bone if diagnosed with osteomyelitis

- Meets certain minimal laboratory criteria.

Exclusion Criteria:

- Has an ulcer infection which, based upon the patient's known history of
hypersensitivity cannot be appropriately treated with at least one of the empiric
systemic antibiotic regimens per protocol.

- Has received > 48 hours of potentially effective antibiotic therapy and the wounds are
clinically improving. If a patient has received an antibiotic within 72 hours, but is
not improving or deep-tissue culture results indicate that the infecting pathogen is
not susceptible to that antibiotic, the patient may be enrolled.

- Requires or is likely to require treatment with any concomitant topical product or
wound therapy during the study period.