Efficacy and Safety of Garamycin® Sponge (Gentamicin-Collagen Sponge) in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

Condition(s) targeted: Diabetic Foot Ulcer

Intervention: Garamycin Sponge (Gentamicin-Collagen sponge) (Drug); Systemic Antibiotic (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Geneva

Overall contact:
Ilker Uckay, MD, Phone: +41 22 372 33 11, Email: Ilker.Uckay@hcuge.ch

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.

Official title: A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percent of patients with a clinical outcome of "clinical cure" at the test of cure visit

Secondary outcome:

Percent of patients with a clinical outcome of "clinical cure" at the end of treatment visit

Percent of patients with a clinical response

Time to clinical cure

The percent of patients with baseline pathogen eradication

Detailed description: Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation. Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin sponge being used in this study is commercially available in Switzerland as Garamycin® Sponge. The Garamycin Sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection. All subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic. Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Ilker Uckay, MD, Phone: +41 22 372 33 11, Email: Ilker.Uckay@hcuge.ch

Geneva University Hospitals, Geneva, Switzerland; Recruiting
Ikler Uckay, Phone: 41 22 372 33 11, Email: Ilker.Uckay@hcuge.ch
Benjamin Kressmann, Email: Benjamin.Kressmann@hcuge.ch
Ilker Uckay, MD, Principal Investigator

Starting date: September 2013
Last updated: September 30, 2013