Treatment for Osteomyelitis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, FL
Osteomyelitis+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an antibiotic may help treat osteomyelitis in diabetic patients.

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Eligible Conditions

  • Osteomyelitis
  • Diabetes
  • Amputations

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 11 secondary outcomes in patients with Osteomyelitis. Measurement will happen over the course of Assessed 6 weeks post intervention.

Year 1
Complete epithelialization of the wound
Month 12
Ambulatory Status
Incidence of Falls
Quality of Life - SF-36
Year 2
Amputation-Free Survival
First occurrence of ipsilateral amputation related to index osteomyelitis
New course of antibacterial therapy for ipsilateral foot infection
Time to Amputation
Month 3
Incidence of adverse events from drug interactions
Incidence of adverse events related to direct toxicity of rifampin
Week 6
Comparative dropout
Year 1
Remission of osteomyelitis

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active drug
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 880 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Placebo
Drug
Patients receive oral riboflavin
Active drug
Drug
Patients receive oral adjunctive rifampin therapy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed 2 years post intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed 2 years post intervention for reporting.

Closest Location

Bay Pines VA Healthcare System, Pay Pines, FL - Bay Pines, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 and 89 years
Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days > 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years
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.
All planned debridement has been completed prior to randomization.
A course of backbone antimicrobial therapy has been selected.

Patient Q&A Section

Can osteomyelitis be cured?

"There is no cure for osteomyelitis and only a small reduction in pain and progression of the illness, but this reduction is more marked in the subacute form of the disease at presentation." - Anonymous Online Contributor

Unverified Answer

What are the signs of osteomyelitis?

"Fever and persistent pain over several days are good signs of an acute infection. Chronic osteomyelitis is the main clinical problem. The most common sign (and complication) is sepsis." - Anonymous Online Contributor

Unverified Answer

How many people get osteomyelitis a year in the United States?

"Approximately 50 000 babies are affected by a new case of osteomyelitis per year in the United States. Osteomyelitis is a devastating disease and one that requires treatment very early in its course, preferably before diagnosis." - Anonymous Online Contributor

Unverified Answer

What is osteomyelitis?

"Osteomyelitis is characterized by progressive destruction of bone and the presence of bone-borne infection. It can occur everywhere in the body but is most prevalent in the jaws, spine and pelvis. The diagnosis of osteomyelitis is often delayed and is often confused with skeletal metastasis. The symptoms vary as an infection progresses. The primary source of infection can be from dental procedures, genitourinary tract infection, open fracture, local trauma, prosthetic joint infection or prosthetic loosening resulting in a dislodged prosthesis." - Anonymous Online Contributor

Unverified Answer

What causes osteomyelitis?

"Osteomyelitis may have a number of causes. The presence of an open wound increases the risk for infection, whereas hematogenous spread of infection predisposes to osteomyelitis in the context of osteoporosis, immunocompromised, or immunosuppressed individuals." - Anonymous Online Contributor

Unverified Answer

What are common treatments for osteomyelitis?

"While antibiotic therapy can be helpful for treating localized osteomyelitis, in cases in which it is not possible to control locally on an individual basis, surgical intervention may be required to remove chronic implants and infected bone tissue. In all cases, long-term follow-up is essential to prevent the development of a second lesion." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for osteomyelitis?

"For osteomyelitis, patients that do not respond to conservative treatment with intravenous and/or oral antibiotics, that have signs or symptoms of complications related with healing bone tissue and who do not attain resolution with these first therapeutic interventions have the best likelihood of having a positive outcome after completing clinical trials." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Most patients with [osteomyelitis] were receiving combination therapies with other treatments for more serious, chronic bone conditions. In patients with acute osteomyelitis, only 24% were treated solely with antibiotics." - Anonymous Online Contributor

Unverified Answer

Does osteomyelitis run in families?

"Osteomyelitis in OMX is a common and severe complication of this disease. The prevalence of osteomyelitis in OMX varies in the different countries, but it is much higher in North America than in Europe. The rate of osteomyelitis in OMX patients varies in different geographic areas and also between different autoinflammatory diseases. In contrast, the familial aggregation of OMX is reported only in the paediatric form of the disease. The aetiological factors in OMX patients differ from those found in the familial cases of the disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating osteomyelitis?

"The only new drug approved for osteomyelitis therapy is a daptomycin formulation for the treatment of Gram-negative infections. In addition, the Centers for Disease Control and Prevention has approved a number of different antibiotic combinations for treating osteomyelitis, including a single agent or poly-drug regimen of ceftazidime (CPX), ciprofloxacin, and clindamycin, or of vancomycin and daptomycin, or of vancomycin and rifampin for recalcitrant cases or when the infection is found to have become resistant to an initial regimen." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets osteomyelitis?

"Older age is a risk factor for developing osteomyelitis, but this cannot be entirely explained by increased BMI. The average age at presentation is 51 years, with the average peak age being 58 years. Most cases represent infection of bone from an asymptomatic primary source." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"Because the treatment of M. tsutsugamushi osteomyelitis is based on the observation of one author before the publication of an existing guideline in 1999, the results highlight two problems in clinical trials – first, the lack of inclusion of the other authors' data. Second, we propose that the authors have not conducted any clinical trials. Since there are no trials that have specifically been conducted to investigate the treatment of M. tsutsugamushi osteomyelitis, then the results of this guideline, which is based on the observation of one author, must, however, be considered inadequate for the treatment of M. tsutsugamushi osteomyelitis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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