Clinical Trial: Diabetic Foot Infection Antibiotic Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Surgical Management of Diabetic Foot Infections - The Role of Post-Operative Antibiotics

Brief Summary: This is a pilot study to explore the effects of long-course versus short course antibiotics on wound healing in surgically managed diabetic foot infections. Hypothesis: Diabetic Foot Infections (DFIs) are best managed with an early aggressive surgical approach and short term antibiotic use. Post-operative prolonged antibiotic use increases costs and resource utilization without improving outcomes.

Detailed Summary:

The purpose of this study is to optimize the management of diabetic foot infections. In this cost conscious health care environment, we believe that equal outcomes can be obtained through more cost effective and efficient means. In order to conduct more definitive studies of the role of antibiotic therapy regimens in diabetic foot infections, we first must collect pilot data to determine both the feasibility and most appropriate methods (sample size, etc.) for designing these larger trials.

Currently, the best way to manage these infections remains elusive; many studies suggest medical management is sufficient with surgical management reserved for failure of medical management or aggressive foot infections; however, this approach leads to recurrence and delays definitive treatment at a significant increase in costs. Several meta-analysis studies have tried to find the best antibiotic regimen; however, due to the vast discrepancies in study design and endpoints no conclusive evidence exists for which is the best antibiotic regimen in patients treated medically, let alone patients with more complicated disease whom require surgical management.

The Infectious Diseases Society of America (IDSA) guidelines have provided recommendations; however, the optimal length is not standardized and to date no studies have looked at the best regimen for post-operative management of surgically treated diabetic foot infections and whether antibiotics help in the healing process. The IDSA guideline suggest that antibiotics are necessary for virtually all infected wounds, but specific guidance for surgically treated wounds is lacking.

This is a randomized, single-blinded study (Infectious disease physicians whom will determine long-term treatment will be blinded). Randomization will occur by bl
Sponsor: Greenville Health System

Current Primary Outcome: Wound Healing [ Time Frame: 3 months ]

Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reinfection/Reintervention [ Time Frame: 3 months ]
    Reinfection or Reintervention to the operative site
  • Clearance of Infection [ Time Frame: 6 weeks ]
    Clearance of infection (as determined by negative culture, normal complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP)
  • Hospital Stay [ Time Frame: 2 weeks ]
    Length of hospital stay, total cost of hospital stay
  • Length of Antibiotics [ Time Frame: 6 weeks ]
    Length of antibiotic


Original Secondary Outcome:

  • Reinfection/Reintervention [ Time Frame: 3 months ]
    Reinfection or Reintervention to the operative site
  • Clearance of Infection [ Time Frame: 6 weeks ]
    Clearance of infection (as determined by negative culture, normal CBC, ESR, and CRP)
  • Hospital Stay [ Time Frame: 2 weeks ]
    Length of hospital stay, total cost of hospital stay
  • Length of Antibiotics [ Time Frame: 6 weeks ]
    Length of antibiotic


Information By: Greenville Health System

Dates:
Date Received: February 22, 2012
Date Started: February 2012
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015