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

Phase 4

Completed

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

Brief 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Garamycin Sponge (Gentamicin-Collagen Sponge)	Garamycin Sponge (Gentamicin-Collagen sponge)	Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care
Systemic Antibiotic	Systemic Antibiotic	Systemic antibiotic therapy and standard ulcer care

Primary Outcome Measures

Name	Time	Method
Clinical Cure	Approximately day 38	Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection

Secondary Outcome Measures

Name	Time	Method
Clinical Response	up to 38 days	Clinical significant improvement is defined as significant improvement of infection but not complete cure (e.g., residual uninfected skin lesions).
Pathogen Eradication	up to 38 days	Microbiological eradication of former infection