Diabetic Foot Infection Antibiotic Study
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | February 2012 |
| End Date: | April 2012 |
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.
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.
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)
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)
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
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