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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by King's College Hospital NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01418456
First received: August 16, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes
Foot Ulcers
Infection
Drug: antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
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.

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Time to healing of foot ulceration in each group [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Percentage of patients who will develop clinical signs of infection over a follow up period of 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • • Percentage of patients in each group that are healed at 20 weeks. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: August 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418456

Contacts
Contact: Maureen Bates, MSc 0044 20 3299 3223 ext 4429 mbates2@nhs.net

Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Prof Mike E Edmonds, FRCP king's College Hospital, London
  More Information

No publications provided

Responsible Party: Professor Mike Edmonds, King's College Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01418456     History of Changes
Other Study ID Numbers: KADFUT, 2010-022518-16
Study First Received: August 16, 2011
Last Updated: August 16, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College Hospital NHS Trust:
diabetes
antibiotics
clean foot ulcers

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014