Diabetic Foot Infection Antibiotic Study

Diabetic Foot Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01539811
• Other study ID #: Pro00015080
• Status: Terminated
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: July 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infections
• Infections

Intervention

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

Drug:
• Short course antibiotics
Short course (<2 weeks) of antibiotics will be prescribed
• Long course antibiotics
Long course (>2 weeks) of antibiotics will be prescribed

Locations

Country	Name	City	State
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

References & Publications (6)

Armstrong DG, Lipsky BA. Diabetic foot infections: stepwise medical and surgical management. Int Wound J. 2004 Jun;1(2):123-32. Review. — View Citation

Fisher TK, Scimeca CL, Bharara M, Mills JL Sr, Armstrong DG. A step-wise approach for surgical management of diabetic foot infections. J Vasc Surg. 2010 Sep;52(3 Suppl):72S-75S. doi: 10.1016/j.jvs.2010.06.011. Review. — View Citation

Joseph WS, Lipsky BA. Medical therapy of diabetic foot infections. J Vasc Surg. 2010 Sep;52(3 Suppl):67S-71S. doi: 10.1016/j.jvs.2010.06.010. Review. — View Citation

Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45. doi: 10.1086/593185. — View Citation

Margolis DJ, Gelfand JM, Hoffstad O, Berlin JA. Surrogate end points for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003 Jun;26(6):1696-700. — View Citation

Stoner MC, Defreitas DJ, Manwaring MM, Carter JJ, Parker FM, Powell CS. Cost per day of patency: understanding the impact of patency and reintervention in a sustainable model of healthcare. J Vasc Surg. 2008 Dec;48(6):1489-96. doi: 10.1016/j.jvs.2008.07.003. Epub 2008 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.	3 months