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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563433
• Other study ID #: MSI-78-304
• Status: Completed
• Phase: Phase 3
• Start date: August 1994
• Est. completion date: July 1996

Study information

• Verified date: September 2020
• Source: Abeona Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: July 1996
• Est. primary completion date: July 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• ofloxacin
400 mg twice a day for 14 days
• MSI-78
1%/2% topical cream twice a day for 14 days

Locations

Country	Name	City	State
United States	Seattle VA Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Abeona Therapeutics, Inc	Genaera Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in clinical signs and symptoms of infection	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	Study day 10
Secondary	Microbiological response	Measure microbiological response to therapy	Study day 10
Secondary	Wound infection score	Measure wound infection score	Study day 10
Secondary	Total wound score	Measure total wound score	Study day 10
Secondary	Wound area	Measure wound area.	Study day 10
Secondary	Wound depth.	Measure wound depth.	Study day 10