MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Completed · Phase 3
Conditions studied: Diabetic Foot Ulcers
In brief
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.
Key facts
- Study ID
- NCT00563433
- Run by
- Abeona Therapeutics, Inc
- People needed
- 342
- Starts
- 1994-08-01
- Expected to finish
- 1996-07-01
- Last updated by the study team
- 2020-09-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Seattle VA Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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