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Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics (KADFUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418456
Recruitment Status : Unknown
Verified January 2011 by King's College Hospital NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Information provided by:
King's College Hospital NHS Trust

Brief Summary:

The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form.

  • All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group.
  • The antibiotic group will receive standard treatment along with antibiotics.
  • The control group will have standard treatment alone.
  • Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks.
  • Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes

Condition or disease Intervention/treatment Phase
Diabetes Foot Ulcers Infection Drug: antibiotics Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Prospective Single Blind Randomised Controlled Study to Compare the Outcomes of Patients With Diabetes and Clinically Non-infected Neuro-ischaemic and Neuropathic Foot Ulcers Treated With and Without Oral Antibiotics.
Study Start Date : August 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Antibiotic Group
Patients in the antibiotic group will remain on antibiotics until their foot ulcer heals or up to 20 weeks
Drug: antibiotics
A variety of antibiotics may be used, according to microbiology results, for up to 20 weeks

No Intervention: Non antibiotic group

Primary Outcome Measures :
  1. Time to healing of foot ulceration in each group [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. • Percentage of patients who will develop clinical signs of infection over a follow up period of 20 weeks [ Time Frame: 20 weeks ]
  2. • Percentage of patients in each group that are healed at 20 weeks. [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients will be eligible for study participation if he or she meets the following criteria

    • Male or female age 18-85 years inclusive
    • Have been diagnosed with Type 1 or Type 2 diabetes
    • Must be able to speak and understand English and be able to provide meaningful written informed consent .
    • If female, is nonpregnant (negative pregnancy tests at the baseline visit) and nonlactating.
    • If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practising one of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:

      • Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline visit.
      • Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline visit).
      • Intrauterine device
      • Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
    • Present with one or more diabetic foot ulcers on or below the malleoli with no clinical signs of infection (using the Infectious Disease Society of America/International Working Group on the Diabetic Foot Guidelines).

Exclusion Criteria:

  • Female subjects who are pregnant or breast feeding
  • Any known intolerance or allergy or reported adverse reaction to any antibiotics
  • Known osteomyelitis
  • Patients with foot ulcers with clinical signs of infection
  • Ulceration caused primarily by a disease other than diabetes.
  • Any other serious disease likely to compromise the outcome of the trial.
  • Evidence of critical renal disease (creatinine >300µmol/L)
  • Patients taking immunosuppressants or any other preparation which may interfere with healing.
  • Participation in another clinical trial in the previous 28 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01418456

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Contact: Maureen Bates, MSc 0044 20 3299 3223 ext 4429

Sponsors and Collaborators
King's College Hospital NHS Trust
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Principal Investigator: Prof Mike E Edmonds, FRCP King's College Hospital, London
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Responsible Party: Professor Mike Edmonds, King's College Hospital NHS Foundation Trust Identifier: NCT01418456    
Other Study ID Numbers: KADFUT
2010-022518-16 ( EudraCT Number )
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: January 2011
Keywords provided by King's College Hospital NHS Trust:
clean foot ulcers
Additional relevant MeSH terms:
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Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Anti-Bacterial Agents
Anti-Infective Agents