Diabetic Foot InfectionsNCT01539811
Diabetic Foot Infection Antibiotic Study
A study testing Surgical incision and drainage of diabetic foot infection, Short course antibiotics and Long course antibiotics in people with Diabetic Foot Infections, run by Prisma Health-Upstate at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infections
- What is being tested?
- Surgical incision and drainage of diabetic foot infection, Short course antibiotics and Long course antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving treatment for moderate (Grade 3-IDSA guidelines) infection of one or more toes from diabetes mellitus
Who cannot join
- 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
Show all 9Show fewer
- Ischemic ulcers
- Gangrene
- Revascularization within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Hospital System University Medical Center
Greenville, South Carolina, 29605
About this study
Official title: Surgical Management of Diabetic Foot Infections - The Role of Post-Operative Antibiotics
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.
Read the 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)
- Conditions
- Diabetic Foot Infections
- Being tested
- Surgical incision and drainage of diabetic foot infection, Short course antibiotics, Long course antibiotics
- Keywords
- Foot Infections, Diabetes, Antibiotic
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical incision and drainage of diabetic foot infectionProcedure or surgery
Also called Surgical debridement, Bone resection, Amputation
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 antibioticsDrug
Also called IV antibiotics, oral antibiotics
Short course (<2 weeks) of antibiotics will be prescribed
Long course antibioticsDrug
Also called IV antibiotics, oral antibiotics
Long course (>2 weeks) of antibiotics will be prescribed
| Study group | Role | What they receive |
|---|---|---|
| Short course antibiotics | Active comparator | Surgical intervention followed by short course of antibiotics (<2 weeks) Receives: Procedure: Surgical incision and drainage of diabetic foot infection; Drug: Short course antibiotics |
| Long course antibiotics | Active comparator | Surgical intervention followed by a long course of antibiotics (>2 weeks) Receives: Procedure: Surgical incision and drainage of diabetic foot infection; Drug: Long course antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Principal investigator decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David L Cull, M.D., Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539811
- Sponsor's protocol ID
- Pro00015080
- Status last verified
- Jul 2022
- First submitted
- 22 Feb 2012
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16722884Joseph 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.
PubMed 20804935Fisher 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.
PubMed 20804936Lipsky 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.
PubMed 18990064Margolis 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.
PubMed 12766096Stoner 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.
PubMed 18829227
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Diabetic Foot Infections - The Role of Post-Operative Antibiotics
- ClinicalTrials.gov ID
- NCT01539811
- Acronym / sponsor ID
- Pro00015080
- Conditions
- Diabetic Foot Infections
- Keywords
- Foot Infections, Diabetes, Antibiotic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator decided to terminate the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Posted 27 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short course antibiotics | Active comparator | Procedure: Surgical incision and drainage of diabetic foot infection, Drug: Short course antibioticsSurgical intervention followed by short course of antibiotics (<2 weeks) |
| Long course antibiotics | Active comparator | Procedure: Surgical incision and drainage of diabetic foot infection, Drug: Long course antibioticsSurgical intervention followed by a long course of antibiotics (>2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving treatment for moderate (Grade 3-IDSA guidelines) infection of one or more toes from diabetes mellitus
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical incision and drainage of diabetic foot infectionAlso: Surgical debridement, Bone resection, AmputationIncision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot | Procedure or surgery | Long course antibiotics, Short course antibiotics |
| Short course antibioticsAlso: IV antibiotics, oral antibioticsShort course (<2 weeks) of antibiotics will be prescribed | Drug | Short course antibiotics |
| Long course antibioticsAlso: IV antibiotics, oral antibioticsLong course (>2 weeks) of antibiotics will be prescribed | Drug | Long course antibiotics |
Primary outcome
Wound Healing
Time frame: 3 months
Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16722884Armstrong 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.
- Background: PubMed 20804935Joseph 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.
- Background: PubMed 20804936Fisher 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.
- Background: PubMed 18990064Lipsky 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.
- Background: PubMed 12766096Margolis 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.
- Background: PubMed 18829227Stoner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Cull, M.D. principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical incision and drainage of diabetic foot infection, Short course antibiotics and Long course antibiotics in people with Diabetic Foot Infections, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539811, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.