Diabetic Foot Infection Antibiotic Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Diabetic Foot Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Short course antibiotics

Surgical intervention followed by short course of antibiotics (\<2 weeks)

Group Type ACTIVE_COMPARATOR

Surgical incision and drainage of diabetic foot infection

Intervention Type PROCEDURE

Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot

Short course antibiotics

Intervention Type DRUG

Short course (\<2 weeks) of antibiotics will be prescribed

Long course antibiotics

Surgical intervention followed by a long course of antibiotics (\>2 weeks)

Group Type ACTIVE_COMPARATOR

Surgical incision and drainage of diabetic foot infection

Intervention Type PROCEDURE

Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot

Long course antibiotics

Intervention Type DRUG

Long course (\>2 weeks) of antibiotics will be prescribed

Interventions

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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

Intervention Type PROCEDURE

Short course antibiotics

Short course (\<2 weeks) of antibiotics will be prescribed

Intervention Type DRUG

Long course antibiotics

Long course (\>2 weeks) of antibiotics will be prescribed

Intervention Type DRUG

Other Intervention Names

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Surgical debridement Bone resection Amputation IV antibiotics oral antibiotics IV antibiotics oral antibiotics

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No