NCT00658957

Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

A Phase II, Randomized, Parallel, Double-blind, Placebo-controlled Study to Assess Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Innocoll · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a physician or podiatrist), compared with placebo sponge combined with standard of care, in preventing infection of diabetic lower extremity skin ulcers.

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 prevent 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-collagen sponge is a thin flat sponge made out of collagen that comes from cow 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. In this study, all subjects will be given the necessary supplies and taught how to take care their foot ulcer. Subjects will be randomly assigned to receive either the gentamicin-collagen sponge or a plain collagen sponge. The sponge will be applied into the ulcer twice a week during the treatment period.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	gentamicin-collagen sponge	5 × 5 cm sponge
DRUG	placebo collagen sponge	5 × 5 cm sponge

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-04-16
• Last updated: 2012-03-23

Locations

1 site across 1 country: United States