Diabetic Foot Infections
Conditions
Keywords
Foot Infections, Diabetes, Antibiotic
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)
Interventions
PROCEDURESurgical 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
Short course (\<2 weeks) of antibiotics will be prescribed
DRUGLong course antibiotics
Long course (\>2 weeks) of antibiotics will be prescribed
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 3 months | Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Course Antibiotics Surgical intervention followed by short course of antibiotics (\<2 weeks)
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
Short course antibiotics: Short course (\<2 weeks) of antibiotics will be prescribed | 0 |
| Long Course Antibiotics Surgical intervention followed by a long course of antibiotics (\>2 weeks)
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
Long course antibiotics: Long course (\>2 weeks) of antibiotics will be prescribed | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Wound Healing
Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.
Time frame: 3 months
Population: study closed with only 2 patient enrolled, who were both deemed ineligible prior to the outcome measure window. No patients reached the 3 month time period for the outcome measure.