Diabetic Foot Infection Antibiotic Study

This study has been terminated.
(Principal investigator decided to terminate the study.)
Sponsor:
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT01539811
First received: February 22, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Diabetic Foot Infections
Procedure: Surgical incision and drainage of diabetic foot infection
Drug: Short course antibiotics
Drug: Long course antibiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Surgical Management of Diabetic Foot Infections - The Role of Post-Operative Antibiotics

Resource links provided by NLM:


Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.


Secondary Outcome Measures:
  • Reinfection/Reintervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reinfection or Reintervention to the operative site

  • Clearance of infection [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of hospital stay, total cost of hospital stay

  • Length of Antibiotics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Length of antibiotic


Enrollment: 2
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short course antibiotics
Surgical intervention followed by short course of antibiotics (<2 weeks)
Procedure: Surgical incision and drainage of diabetic foot infection
Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Other Names:
  • Surgical debridement
  • Bone resection
  • Amputation
Drug: Short course antibiotics
Short course (<2 weeks) of antibiotics will be prescribed
Other Names:
  • IV antibiotics
  • oral antibiotics
Active Comparator: Long course antibiotics
Surgical intervention followed by a long course of antibiotics (>2 weeks)
Procedure: Surgical incision and drainage of diabetic foot infection
Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Other Names:
  • Surgical debridement
  • Bone resection
  • Amputation
Drug: Long course antibiotics
Long course (>2 weeks) of antibiotics will be prescribed
Other Names:
  • IV antibiotics
  • oral antibiotics

Detailed Description:

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 blocked random allocation scheme using randomization software and a block size of 10. The study coordinator will keep the randomization schedule/log and inform the surgeon which therapy the patient will receive

  • Treatment group #1: Surgical intervention, short term course of antibiotics (< 2 week post-op)
  • Treatment group #2: Surgical intervention, long term course of antibiotics (> 2 week post-op)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving treatment for moderate (Grade 3-IDSA guidelines) infection of one or more toes from diabetes mellitus

Exclusion Criteria:

  • IDSA Grade 1,2, or 4 infections
  • Non-diabetic foot ulcers
  • Non-infected foot ulcers
  • Sepsis
  • Currently taking antibiotics for reasons not related to foot infection
  • Infections requiring a transmetatarsal amputation
  • Ischemic ulcers
  • Gangrene
  • Revascularization within the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539811

Locations
United States, South Carolina
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Hospital System University Medical Center
Investigators
Principal Investigator: David L Cull, M.D. Greenville Hospital System University Medical Center
  More Information

Publications:
Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT01539811     History of Changes
Other Study ID Numbers: Pro00015080
Study First Received: February 22, 2012
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Greenville Hospital System University Medical Center:
Foot Infections
Diabetes
Antibiotic

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Communicable Diseases
Focal Infection
Infection
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014