Clinical trial NCT01539811
Conditions: Diabetic Foot Infections
Keywords: Foot Infections Diabetes Antibiotic
Sponsor: Prisma Health-Upstate
Start date: 2012-02-01; Completion date: 2012-04-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 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)

Arms: arm 1: Surgical intervention followed by short course of antibiotics (\<2 weeks) arm 2: Surgical intervention followed by a long course of antibiotics (\>2 weeks)
Interventions: intervention 1: Surgical incision and drainage of diabetic foot infection intervention 2: Short course antibiotics intervention 3: Long course antibiotics
Intervention descriptions: intervention 1: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot intervention 2: Short course (\<2 weeks) of antibiotics will be prescribed intervention 3: Long course (\>2 weeks) of antibiotics will be prescribed

Protocol documents: