Phase 4
Completed N=88
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
Source: ClinicalTrials.gov NCT01951768 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Clinical Cure — 38; 39 participants
◆ Published Evidence
Established
64citations · ~8 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure |
38; 39 | — |
| SECONDARY Clinical Response |
7; 13 | — |
| SECONDARY Pathogen Eradication |
26; 20 | — |
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) and the linked publication. 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. Informational only — not medical advice.