Diabetic Foot Ulcer Clinical Trial
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
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.
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.
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