Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Innocoll Technologies Premier Research Group plc |
---|---|
Information provided by: | Innocoll Technologies |
ClinicalTrials.gov Identifier: | NCT00593567 |
The purpose of this study is to determine whether the gentamicin-collagen sponge (Collatamp G topical) when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
Condition | Intervention | Phase |
---|---|---|
Diabetic Foot Ulcer |
Drug: gentamicin-collagen sponge Drug: Levofloxacin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge (Collatamp® G) Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer |
Estimated Enrollment: | 72 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Daily topical gentamicin sponge and standard daily wound care
|
Drug: gentamicin-collagen sponge
Inserted daily into open ulcer
|
B: Active Comparator
Daily oral levofloxacin 750 mg and standard daily wound care
|
Drug: Levofloxacin
750mg oral levofloxacin daily
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing 1 of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
Exclusion Criteria:
Contact: Lisa Hemsen | 860-610-5530 ext 5530 | skinulcers@premier-research.com |
United States, Maryland | |
Chesapeake Research Group LLC | Recruiting |
Pasadena, Maryland, United States, 21122 |
Study Director: | David Prior | Innocoll Technologies |
Responsible Party: | Innocoll Holdings Inc. ( David Prior, Executive Vice President, Scientific Affairs ) |
Study ID Numbers: | INN-TOP-001 |
Study First Received: | January 4, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00593567 |
Health Authority: | United States: Food and Drug Administration |
Diabetic Foot Ulcer |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Ofloxacin Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Gentamicins Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Anti-Infective Agents, Urinary Enzyme Inhibitors Cardiovascular Diseases Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |