A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer - INN-TOP-005

Innocoll Pharmaceuticals Ltd.0 sites8 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Innocoll Pharmaceuticals Ltd.
Enrollment: 8
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

September 27, 2016

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Innocoll Pharmaceuticals Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Is aged \>\= 18 and \<\= 85 years.
•2\. Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
•3\. Has 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 guidelines for the \*Diagnosis and Treatment of Diabetic Foot Infections\* (CID 2012; 54:132\-173\) (IDSA guidelines):
•has \>\= 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion)
•has \>\= 1 of the following characteristics: erythema \> 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis)
•For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut).
•4\. Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure \>\= 45 mm Hg or participation is approved by a vascular surgeon);
•5\. Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis. \[Note: The investigator is referred to Diabetes Metab Res Rev 2008; 24(Suppl 1\): S145\-S161 for recommendations for the diagnosis of diabetic foot osteomyelitis.]
•6\. Has received appropriate surgical debridement to remove all gangrenous tissue.
•7\. If female, is nonpregnant (negative pregnancy test results at the baseline/randomization visit) and nonlactating.

Exclusion Criteria

•1\. Has a known history of hypersensitivity to gentamicin (or other aminoglycosides).
•2\. Has a known or suspected hypersensitivity to bovine collagen.
•3\. Has an ulcer infection which, based upon the patient\*s known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol.
•4\. Has an ulcer associated with prosthetic material or an implanted device.
•5\. Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization.
•6\. Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow\-up study visit.
•7\. Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator.
•8\. Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator.
•9\. Has a history of epilepsy.
•10\. Has a history of alcohol or substance abuse in the past 12 months.