[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

(857) 364-6130

Email address

john.hermos@va.gov

Condition

Amputation,Diabetes,Osteomyelitis

Treatment type

Interventional

Investigational product

Riboflavin Placebo

Phase

Phase 4

Sponsor

VA Office of Research and Development

ClinicalTrials.gov identifier

NCT03012529

Study number

2-001

Understanding clinical trials

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. 1) use of oral hypoglycemic agents or insulin at the time of enrollment;
  2. 2) a hemoglobin A1c (
  3. HgA1c) level within the past 90 days > 6.5; or
  4. 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years 3. Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment. 4. All planned debridement has been completed prior to randomization. 5. A definitive course of backbone antimicrobial therapy has been selected.
Exclusion criteria
  1. WBC) <2000 cells/mm3 OR platelet count <50,000 cells/mm3** OR hemoglobin <8.0 g/dL.**,*** 9. Women of child-bearing potential (those with menses within the last
  2. year) with a positive serum pregnancy test. 10. Patient is believed unlikely to be able to complete the trial due to medical conditions such as metastatic cancer or end-stage organ failure. 11. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses. 12. Patient refuses or is clinically unable to undergo the recommended level of debridement. 13. The patient's prescribed backbone antibiotic therapy does not meet standard of care for either empirical treatment or culture-directed therapy. 14. Indwelling hardware present in the foot, at the site of the index osteomyelitis. 15. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days. - Patients with total bilirubin > 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study. - Patients with platelet count <50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study. - If multiple laboratory values are available, the most recent value will be applied for eligibility.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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