Diabetic Foot Infection Antibiotic Study

July 18, 2022 updated by: Prisma Health-Upstate

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing
Time Frame: 3 months
Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: David L Cull, M.D., Prisma Health-Upstate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00015080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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