Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
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|ClinicalTrials.gov Identifier: NCT00593567|
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 31, 2022
Last Update Posted : May 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Drug: gentamicin-collagen sponge Drug: Levofloxacin||Phase 2|
Infected skin ulcers in patients 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 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 of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Daily topical gentamicin sponge and standard daily wound care
Drug: gentamicin-collagen sponge
Inserted daily into open ulcer
Active Comparator: B
Daily oral levofloxacin 750 mg and standard daily wound care
750mg oral levofloxacin daily
- Number of Participants With a Clinical Outcome of "Clinical Cure" [ Time Frame: Final Study Visit (Day 21 [or 28 or 35]) ]Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.
- Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group [ Time Frame: Each time point (Day 3, 7 [14 and 21 if necessary]) ]Number of participants with a clinical outcome of "clinical cure" in each treatment group at/by each time point (except the Final Study Visit). Clinical Cure is defined as positive clinical response and with pathogen eradication.
- Time to Baseline Pathogen Eradication [ Time Frame: assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported ]
- Number of Participants With Complete Wound Closure by Each Visit [ Time Frame: At each timepoint Day 3, 7, 14 & 21 ]
- Time to Clinical Cure [ Time Frame: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ]Time to Clinical Cure is measured by days to the first observed cure. Clinical Cure is defined as positive clinical response and with pathogen eradication.
- Time to Pathogen Eradication [ Time Frame: Actual time assessed (Day 1-21 ]Time to Baseline Pathogen Eradication summed
- Time to Positive Clinical Response [ Time Frame: (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593567
|United States, Maryland|
|Chesapeake Research Group LLC|
|Pasadena, Maryland, United States, 21122|
|Study Director:||David Prior||Innocoll|