Diabetes Clinical Trial
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.
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
Trail Procedures Visit 0 Screening, Randomisation and Initial Treatment;
1. The researcher will assign a screening number.
2. Medical history and demographics will be recorded.
3. Physical examination including height and weight will be performed.
4. Vital signs (body temperature, pulse and blood pressure) will be recorded.
5. Random capillary blood glucose will be measured.
6. 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.
VASCULAR ASSESSMENT
15. Palpation of pedal pulses namely dorsalis pedis and posterior tibial will be carried
out. Ulcers occurring on the foot with impalpable pedal pulses will be defined as
ischaemic ulcers.
16. If pulses are impalpable, ankle- brachial pressure index and transcutaneous oxygen
(TcPo2) measurements will be performed and recorded. Patients will be reviewed by the
vascular team together with their vascular studies. The vascular consultant, diabetes
consultant and the patient will make a decision regarding any vascular intervention
such as angioplasty or bypass or to continue with conservative management.
17. Patients who have ischaemic feet will have their TcPo2 monitored on a once monthly
basis. If there is any deterioration in their blood supply they will be seen by the
vascular team to consider vascular intervention with either by-pass or angioplasty or
continue with monitoring.
18. A scotch cast boot (SCB) to optimise offloading for the ischaemic ulcer, will be
manufactured for patients with impalpable pedal pulses as per standard clinical
practice.
NEUROLOGICAL ASSESSMENT
19. Peripheral sensation testing will be carried out using a neurothesiometer to determine
vibration perception threshold on the apex of the toe of the foot with the ulcer. A 10g
nylon monofilament will be applied to the plantar surface of the 1st toe, and to the
plantar surface of the 1st ,3rd and 5th metatarsal heads and heel. Patients will be
deemed to have neuropathy if the vibration perception threshold is abnormal or the
filament cannot be felt on the plantar surface at any of the sites.
Ulcers occurring on the foot with abnormal vibration perception or 10g filament testing
will be defined as neuropathic ulcers.
20. A removable total contact cast (RTCC) to optimise offloading in the neuropathic ulcer,
will be manufactured as per standard clinical practice.
21. All patients will be asked to complete:
Quality of life questionnaire SF-36 EuroQol-5 questionnaire (EQ-5D)
22. All patients in the trial will be given emergency contact details.
Randomisation
- Patients will be randomised to one of two groups
- The antibiotic group
- The standard treatment only group
Antibiotics will be dispensed from the hospital pharmacy. Patients will be advised that
there will always be two teams of health care professionals monitoring them: the blinded
team, which is the team who do not know which treatment group the patient has been assigned,
and the un blinded team, which is the team who do know what treatment group to which the
patient has been assigned .The patient will be asked not to inform the blinded team as to
which group they belong.
Visits 1-19
The unblinded team will always see the patient first.
Adverse events will be noted and assessed Adherence to treatment will be assessed and
recorded Details of the resources that have been used by the patient for treatment of their
ulcer will be recorded in order to carry out a health economic evaluation.
1. Vital signs will be recorded (body temperature, pulse and blood pressure).
2. Random capillary blood glucose will be measured.
3. Patients with ischaemic ulcers will have their TcPO2 measured at four weekly intervals
weeks 4,8,12,16 and 20.
The blinded team will carry out the following assessments;
4. Ulcer characteristics (size, depth, site).
5. Presence of clinical signs of infection such as; redness, swelling, pain, malodour,
purulent discharge.
6. A tissue specimen from the ulcer bed will be sent for culture and sensitivity, at week
4,8,12,16 and 20. An ulcer swab will be taken at all other visits.
7. A digital photograph will be taken
8. The ulcer circumference will be marked out using sterile graph paper and a marker pen.
9. The SCB or RTCC will be checked with patient.
10. The ulcer will be cleansed using normal saline, a standard non adherent dressing and a
surgipad dressing held in place with a bandage will be applied to the ulcer.
11. The ulcer will be deemed infected or non- infected.
12. The blinded team will inform the unblinded team whether the ulcer is healed ; if it is
not healed, whether it is infected or non infected, using the Infectious Disease
Society of America/International Working Group on the Diabetic Foot Guidelines
(IDSA-IWGDF) criteria for infection. This will be confirmed by two members of the
blinded team If the ulcer is deemed to be clinically non-infected, and patient is to
continue in the study, antibiotics will be rationalised by the unblinded team according
to culture and sensitivity results from the ulcer swab/biopsy. An appropriate clinical
trial prescription will be written.
13. Emergency contact details will be checked with the patient.
14. Patients will be followed up to 20 weeks. The patient will be withdrawn from the study
before the 20 weeks has elapsed if a foot ulcer has developed clinical signs of
infection or the ulcer has healed or the patient has developed side effects
necessitating the patient to stop antibiotic therapy for more than 72 hours or is
withdrawn by the Investigator for any other reason.
15. If the patient is withdrawn early termination procedures will be completed (as per
visit 20 or below).
If a patient is withdrawn and experiences adverse events such as
- Admission to hospital
- Amputation
- Ulcer non healing
- Side effects of antibiotics Then details of these events will be subsequently recorded
from patient's notes to further complete a health economic evaluation.
Visit 20; Last treatment visit or early termination visit
If the ulcer has not healed after 20 weeks then Visit 20 will be the last treatment visit.
Early termination of the study will be carried out if the patient has healed before 20
weeks, or decides to withdraw (and is willing to attend a final visit); or the patient
develops a foot ulcer with clinical signs of infection. If the patient has developed side
effects from antibiotics and has not taken the antibiotics for more than 72 hours then the
patient will be withdrawn from the study.
The unblinded team will always see the patient first.
1. Adverse events will be noted and assessed.
2. Adherence to treatment will be assessed and recorded.
3. Details of the resources that have been used by the patient for treatment of their
ulcer will be recorded in order to carry out a health economic evaluation.
4. A physical examination will be carried out.
5. Vital signs will be recorded (body temperature, pulse and blood pressure).
6. Random capillary blood glucose will be measured.
7. Patients with ischaemic ulcers will have their TcPO2 measured.
8. Blood will be collected for the following investigations as per routine clinic practice
Calcium and phosphate Renal and liver function Glycated haemoglobin. C- reactive
protein Full blood cell count Erythrocyte sedimentation rate Blood glucose Also blood
will be taken for high sensitivity C- reactive protein and procalcitonin
9. The patients will be asked to complete Quality of life questionnaire (SF-36) EuroQol-5
questionnaire (EQ-5D)
Visit procedures by the blinded team
10. Standard ulcer treatment if the ulcer remains unhealed will be carried out. (the
removal of callous, any dry skin, any dead tissue in and around the ulcer with a
scalpel, ulcer cleansing and application of a dressing)
11. A small tissue sample or ulcer swab will be collected from the ulcer bed for culture
and sensitivity
12. Ulcer characteristics (size, depth, site) presence of signs of infection (redness,
swelling, pain, malodour, purulent discharge) will be noted.
13. The ulcer circumference will be marked out using sterile graph paper and a marker pen.
14. A digital photograph will be taken of the ulcer.
15. The blinded team will inform the unblinded team whether the ulcer is healed ; if it is
not healed whether it is infected or non infected, using the Infectious Disease Society
of America/International Working Group on the Diabetic Foot Guidelines (IDSA-IWGDF )
criteria for infection. This will be confirmed by two members of the blinded team
If a patient experiences adverse events such as
- Admission to hospital
- Amputation
- Ulcer non healing
- Side effects of antibiotics Then details of these events will be subsequently recorded
from patient's notes, to further complete a health economic evaluation.
Post treatment evaluation
Every patient will be seen 14 days after the last treatment visit or 14 days after the visit
when they have been withdrawn from the study. The purpose of this visit is twofold: first to
act as a safety visit and secondly, in the case of those patients who had healed at their
previous visit to confirm healing.
Visit procedure;
Unblinded team
1. Adverse events will be noted and assessed
2. Body temperature, pulse and blood pressure will be recorded
Blinded team
3. Standard foot ulcer care will be carried out if the ulcer remains unhealed.
4. If the ulcer had healed at the last visit, then the foot will be examined to confirm
healing
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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