Phase 4
N=88
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01951768 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Clinical Cure — 38; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Garamycin Sponge (Gentamicin-Collagen sponge) (Drug); Systemic Antibiotic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Geneva
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure |
38; 39 | — |
| SECONDARY Clinical Response |
7; 13 | — |
| SECONDARY Pathogen Eradication |
26; 20 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01951768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.