Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Garamycin® Sponge (Gentamicin-Collagen Sponge) in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951768
Recruitment Status : Unknown
Verified September 2013 by Ilker Uckay, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : September 27, 2013
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
Ilker Uckay, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Garamycin Sponge (Gentamicin-Collagen sponge) Drug: Systemic Antibiotic Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Garamycin Sponge (Gentamicin-Collagen Sponge)
Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care
Drug: Garamycin Sponge (Gentamicin-Collagen sponge)
Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)

Active Comparator: Systemic Antibiotic
Systemic antibiotic therapy and standard ulcer care
Drug: Systemic Antibiotic

Antibiotics options per protocol:

Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h





Primary Outcome Measures :
  1. The percent of patients with a clinical outcome of "clinical cure" at the test of cure visit [ Time Frame: Approximately day 38 ]

Secondary Outcome Measures :
  1. Percent of patients with a clinical outcome of "clinical cure" at the end of treatment visit [ Time Frame: approximately 28 days ]
  2. Percent of patients with a clinical response [ Time Frame: up to 38 days ]
  3. Time to clinical cure [ Time Frame: up to 38 days ]
  4. The percent of patients with baseline pathogen eradication [ Time Frame: up to 38 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT01951768


Contacts
Layout table for location contacts
Contact: Ilker Uckay, MD +41 22 372 33 11 Ilker.Uckay@hcuge.ch
Contact: Benjamin Kressmann, RN benjamin.kressmann@hcuge.ch

Locations
Layout table for location information
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland
Contact: Ikler Uckay    41 22 372 33 11    Ilker.Uckay@hcuge.ch   
Contact: Benjamin Kressmann       Benjamin.Kressmann@hcuge.ch   
Principal Investigator: Ilker Uckay, MD         
Sponsors and Collaborators
University Hospital, Geneva

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ilker Uckay, Consultant Service of Infectious Diseases, Consultant for Septic Orthopaedics, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01951768     History of Changes
Other Study ID Numbers: HUG protocol
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Anti-Bacterial Agents
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action