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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00563433
Other study ID # MSI-78-304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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