|drug3362||Riboflavin Placebo Wiki||1.00|
There is one clinical trial.
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
Description: The primary endpoint is amputation-free survival, ending with amputation or death from any cause. Amputation is defined as surgical treatment of osteomyelitis by removal or debridement of necrotic/infected bone (all or part of a bone) from a lower extremity limb or digit on the ipsilateral side of the protocol-treated osteomyelitis. Debridement prior to randomization may include removal of bone. Because this debridement occurs early, prior to exposure to study drug or placebo, removal of bone at that time is not a study endpoint.Measure: Amputation-Free Survival Time: Assessed 2 years post intervention
Description: Time from randomization to the occurrence of the components of the primary outcome: the first occurrence of ipsilateral amputation alone the first occurrence of ipsilateral above-ankle amputation the first occurrence of ipsilateral through the ankle (e.g. Symes amputation) or below-ankle amputation proximal to the metatarsal-phalangeal joint the first occurrence of ipsilateral below-ankle amputation at or distal to the metatarsal-phalangeal joint all cause death Endpoint will be determined by chart review by the Study Coordinator, with confirmation by the Site Investigator, and as needed, by the Study Chair.Measure: Time to Amputation Time: Assessed 2 years post intervention
Description: New courses of antibacterial therapy for ipsilateral foot infection during the first year after randomization (yes/no per patient). Endpoint will be determined by chart review by the Study Coordinator, with consultation with the Site Investigator as needed to confirm that the new course of treatment is directed toward continued or recurrent osteomyelitis of the initially affected lower extremity. The new course will require there be at least a 14 day interval between the end of the initial back-bone antibiotic therapy course.Measure: New course of antibacterial therapy for ipsilateral foot infection Time: Assessed 2 years post intervention
Description: Quality of life, measured by the 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992) and its physical and mental health subscales. This is a widely used self-report instrument that will be administered by the Study Coordinator at baseline, 3-, 6- and 12-months.Measure: Quality of Life - SF-36 Time: Assessed 12 months post intervention
Description: Ambulatory status, measured by the Study Coordinator, using a modified item from the Amputee Mobility Predictor Questionnaire56. The patient's "usual method of ambulation within the home" will be assessed by a single self-report item at baseline, 3-, 6- and 12-months using the following response categories: No assistive device required to move about Cane Crutches Walker Wheelchair Bed boundMeasure: Ambulatory Status Time: Assessed 12 months post intervention
Description: Incidence of falls, measured by self-reported frequency of falls and falls that required medical attention in the one-month periods preceding research visits at Baseline, 3-, 6- and 12-months.Measure: Incidence of Falls Time: Assessed 12 months post intervention
Description: Incidence of adverse events related to direct toxicity of rifampin in active drug vs. placebo groups: Nausea requiring dividing the dose to twice a day Rash requiring study drug discontinuation Nausea requiring study drug discontinuation Grade 3 or 4 liver enzyme (ALT) elevations Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.Measure: Incidence of adverse events related to direct toxicity of rifampin Time: Assessed 3 months post intervention
Description: Incidence of adverse events from drug interactions in active drug vs. placebo groups: Cardiovascular: Myocardial infarction, cerebrovascular accident, hospitalization for hypertensive emergency Glycemic control: Hospitalization for a primary diagnosis of hypoglycemia or uncontrolled diabetes Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.Measure: Incidence of adverse events from drug interactions Time: Assessed 3 months post intervention
Description: Overall comparative dropout data during the 6-week intervention based on drug intolerance/drug interactions/adverse events in active drug vs. placebo groups. Dropout endpoint will be determined by chart review by the Study Coordinator and by telephone calls to the subject.Measure: Comparative dropout Time: Assessed 6 weeks post intervention
Description: Remission of osteomyelitis at 12 months (yes/no). Remission is defined as epithelialization of any overlying soft tissue defect and the absence of local signs and symptoms of inflammation. Endpoint will be determined by physical examination by the Site Investigator at the 12 month visit.Measure: Remission of osteomyelitis Time: Assessed at 1 year post intervention
Description: Complete epithelialization of the wound at 6 weeks and at 3, 6 and 12 months (yes/no). Endpoint will be determined by physical examination by the Site Investigator at the 3, 6 and 12 month visits.Measure: Complete epithelialization of the wound Time: Assessed 1 year post intervention
Description: Time from randomization to the first occurrence of ipsilateral amputation for the treatment of osteomyelitis related to the index osteomyelitis. Relatedness will be determined by the LSI or qualified Co-investigator on thePrimary Outcome case report form. An episode of ipsilateral osteomyelitis is considered related to the index osteomyelitis if it involves the same bone or a contiguous bone.Measure: First occurrence of ipsilateral amputation related to index osteomyelitis Time: Assessed 2 years post intervention
Data processed on September 26, 2020.
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