NCT01539811

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2015

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

February 22, 2012

Results QC Date

April 13, 2015

Last Update Submit

July 18, 2022

Conditions

Diabetic Foot Infections

Keywords

Foot InfectionsDiabetesAntibiotic

Outcome Measures

Primary Outcomes (1)

  • Wound Healing

    Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.

    3 months

Study Arms (2)

Short course antibiotics

ACTIVE COMPARATOR

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

Procedure: Surgical incision and drainage of diabetic foot infectionDrug: Short course antibiotics

Long course antibiotics

ACTIVE COMPARATOR

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

Procedure: Surgical incision and drainage of diabetic foot infectionDrug: Long course antibiotics

Interventions

Surgical incision and drainage of diabetic foot infectionPROCEDURE

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

Also known as: Surgical debridement, Bone resection, Amputation
Long course antibioticsShort course antibiotics
Short course antibioticsDRUG

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

Also known as: IV antibiotics, oral antibiotics
Short course antibiotics
Long course antibioticsDRUG

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

Also known as: IV antibiotics, oral antibiotics
Long course antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving treatment for moderate (Grade 3-IDSA guidelines) infection of one or more toes from diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenville Hospital System University Medical Center

Greenville, South Carolina, 29605, United States

Location

Related Publications (6)

  • Armstrong DG, Lipsky BA. Diabetic foot infections: stepwise medical and surgical management. Int Wound J. 2004 Jun;1(2):123-32. doi: 10.1111/j.1742-4801.2004.00035.x.

    PMID: 16722884BACKGROUND

  • 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.

    PMID: 20804935BACKGROUND

  • 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.

    PMID: 20804936BACKGROUND

  • 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.

    PMID: 18990064BACKGROUND

  • 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. doi: 10.2337/diacare.26.6.1696.

    PMID: 12766096BACKGROUND

  • 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.

    PMID: 18829227BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Amputation, SurgicalAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativeAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. David Cull
Organization
Greenville Health System
dcull@ghs.org
8644548295

Study Officials

  • David L Cull, M.D.

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 21, 2022

Results First Posted

April 27, 2015

Record last verified: 2022-07

Locations

US(1)