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

NCT00563394 | Completed Phase 3

• 1 other identifier: MSI-78-303
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers

Keywords

diabetic; diabetes mellitus; foot; ulcers; Floxin; oral antibiotic; topical cream

Outcome Measures

Primary Outcomes (1)

• Reduction in clinical signs and symptoms of the infection

  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 Outcomes (5)

• microbiological response to therapy,

  Study day 10

• Wound infection score

  Study day 10

• Total wound score

  Study day 10

• Wound Area

  Study day 10

• Wound Depth

  Study day 10

Study Arms (2)

ofloxacin

ACTIVE COMPARATOR

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

Drug: ofloxacin

MSI-78

ACTIVE COMPARATOR

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.

Drug: MSI-78

Interventions

ofloxacin DRUG

400 mg twice a day for 14 days

Also known as: Floxin

ofloxacin

MSI-78 DRUG

1%/2% topical cream twice a day for 14 days

MSI-78

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abeona Therapeutics, Inc: lead
• Genaera Corporation: collaborator

Study Sites (1)

Seattle VA Medical Center

Seattle, Washington, 98108-1597, United States

Location

Related Publications (1)

• Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45. doi: 10.1086/593185.

  PMID: 18990064 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Ulcer

Interventions

Ofloxacin; pexiganan

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul Litka, MD

  Magainin Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: August 1, 1994
• Primary Completion: July 1, 1996
• Study Completion: July 1, 1996
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

US (1)