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

Phase 3

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Drug: ofloxacin; Drug: MSI-78

• Registration Number: NCT00563433
• Lead Sponsor: Abeona Therapeutics, Inc

Brief 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.

Detailed Description

Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers.

This is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.

Study Timeline

• Study Start: 1994-08
• Primary Completion: 1996-07
• Study Completion: 1996-07
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ofloxacin	ofloxacin	an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted
MSI-78	MSI-78	an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.

Primary Outcome Measures

Name	Time	Method
Reduction in clinical signs and symptoms of infection	Study day 10	Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy

Secondary Outcome Measures

Name	Time	Method
Wound area	Study day 10	Measure wound area.
Wound depth.	Study day 10	Measure wound depth.
Microbiological response	Study day 10	Measure microbiological response to therapy
Wound infection score	Study day 10	Measure wound infection score
Total wound score	Study day 10	Measure total wound score

Trial Locations

Locations (1)

Seattle VA Medical Center; 🇺🇸 Seattle, Washington, United States