MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

• Status: Completed
• Trial end date: 1996-07-01
• Target enrollment: 0
• Participant gender: All

Summary

224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abeona Therapeutics, Inc; MacroChem Corporation
• Collaborator: Genaera Corporation
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Non-hospitalized ambulatory patients with diabetes mellitus

• Men or Women greater than 18 years old

• Patients must be considered reliable, willing and able to give consent

• Female patients must be postmenopausal for a least 6 months or surgically sterilized

• Localized infection of the ulcer that would ordinarily be treated on an outpatient basis

• Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected

• Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis

• Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot

• Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry

Exclusion Criteria:

• Patients requiring concurrent local or systemic antimicrobials during the study period for other infections

• Patients who are currently treated or awaiting dialysis

• Patients who are unable to care for their ulcers

• Patients with known alcohol or substance abuse within 6 months or study entry

• Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin

• Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents

• Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.

• Previous enrollment in this study or previous treatment with MSI-78 Topical Cream

• Patients with gangrene or severely impaired arterial supply to any portion of the affected foot

• Other conditions considered by the investigator to be sound reason for disqualification

• Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream

• Women who are breast feeding, pregnant or attempting to become pregnant