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.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 166
- Primary Endpoint
- Time to healing of foot ulceration in each group
Study Overview
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
Detailed Description
Trail Procedures Visit 0 Screening, Randomisation and Initial Treatment;
- The researcher will assign a screening number.
- Medical history and demographics will be recorded.
- Physical examination including height and weight will be performed.
- Vital signs (body temperature, pulse and blood pressure) will be recorded.
- Random capillary blood glucose will be measured.
- Blood investigations as per routine clinical practice in the Diabetic Foot Clinic will be carried out including:
Calcium and Phosphate Renal and liver function Glycated haemoglobin C- Reactive Protein (CRP) Full blood cell count Erythrocyte sedimentation rate Blood glucose Blood will also be taken for high sensitivity C-reactive protein, and procalcitonin levels as inflammatory markers. (Samples will be stored in a -80 deg C freezer, to be analysed at a later date) 7. A urine test for Beta human chorionic gonadotropin test for women of childbearing potential will be carried out 8. The foot ulcer will then be debrided of callous and any macerated tissue and details of the ulcer will be recorded as follows; 9. Ulcer characteristics and presence of signs of infection (redness, swelling, pain, malodour, purulent discharge) . 10. In order to enter the study, the patient will need to have a clinically non- infected ulcer.
If patients have more than one ulcer, each ulcer should have no clinical signs of infection and the largest foot ulcer will be recorded as the target ulcer and will be monitored in the study. (The remaining ulcers will be treated according to standard clinical practice.)
At this stage inclusion/ exclusion criteria will be reviewed and if satisfied, the patient will be admitted to the study. 11. The circumference of the ulcer selected for the study will be marked out using sterile graph paper and a marker pen. 12. A digital photograph will be taken. The patient will be asked to sign a consent form for this as part of King's College Hospital NHS Trust policy. 13. A tissue sample( ulcer biopsy) will be sent for culture and sensitivity 14. The foot ulcer will then be cleansed with normal saline. A sterile non adherent dressing along with a surgipad dressing will be applied to the foot ulcer. If appropriate the patient's usual carers can be shown the dressings to be used and be given training to ensure correct application of the dressings between visits to the clinic. Dressing changes should occur according to the amount of exudate discharging from the ulcer, ie. every day, every second, third day or three times a week. Patients will be advised to keep their ulcer dressings dry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Active Antibiotic Group
Patients in the antibiotic group will remain on antibiotics until their foot ulcer heals or up to 20 weeks
Intervention: antibiotics (Drug)
Outcomes
Primary Outcomes
Time to healing of foot ulceration in each group
Time Frame: 20 weeks
Secondary Outcomes
- • 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)