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

NCT01418456 | Unknown Phase 4 DMC

• 2 other identifiers: KADFUT2010-022518-16
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetes; Foot Ulcers; Infection

Keywords

diabetes; antibiotics; clean foot ulcers

Outcome Measures

Primary Outcomes (1)

• Time to healing of foot ulceration in each group

  20 weeks

Secondary Outcomes (2)

• • Percentage of patients who will develop clinical signs of infection over a follow up period of 20 weeks

  20 weeks

• • Percentage of patients in each group that are healed at 20 weeks.

  20 weeks

Study Arms (2)

Active Antibiotic Group

EXPERIMENTAL

Patients in the antibiotic group will remain on antibiotics until their foot ulcer heals or up to 20 weeks

Drug: antibiotics

Non antibiotic group

NO INTERVENTION

Interventions

antibiotics DRUG

A variety of antibiotics may be used, according to microbiology results, for up to 20 weeks

Active Antibiotic Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Prof Mike E Edmonds, FRCP

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Bates, MSc

CONTACT

0044 20 3299 3223; mbates2@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 17, 2011

Record last verified: 2011-01