Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00563433
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00563433
Study Brief:
Protocol Section:
NCT00563433