Diabetic foot ulcer Circulatory System
Conditions
Interventions
Following written consent, at week 0, participants are allocated at random to one of the three arms in a 1:1:1 fashion. A randomised sequence from the freeware randomisation programme, see https://www
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of a Foot Ulcer, present on area that is measurable with a grid sheet (this can include plantar, calcaneus, dorsal, hallux, apex, toe, or ankle-based ulcers). This includes DFU, peripheral arterial disease related wound, or other aetiology. Ulcer should not penetrate the tendon, periosteum or bone 2. Foot ulcer present for at least 6 weeks 3. Adult patients aged >18 years 4. Mental capacity to give consent 5. At least one of the following factors: 5.1. Poorly controlled diabetes (Hba1c > 8% / 64 mmol/mol measured within last 6 months) 5.2. Multiple concurrent foot ulcers 5.3. Recurrence of wounds 5.4. Wound present for more than 18 weeks 5.5. Peripheral arterial disease 5.6. Poor compliance with best practice in foot ulcer management, including non-optimal use of off-loading device
Exclusion criteria
Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 3. Limited life expectancy, i.e. undergoing palliative care 4. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention) 5. Currently receiving antibiotics (topical or systemic), or within one week of receiving antibiotics. 6. Patients who are participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, immune disorder) 7. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, including alcohol or drug dependency. 8. Foot ulcer in area of the foot which would make ulcer size measurement impossible 9. Patient pregnant, actively planning to become pregnant, or lactating 10. Ankle brachial index 0.6 then patient can be enrolled) 11. Any condition that is contraindicated for the use of any of the dressings used in this trial. This includes the earlier mentioned pregnancy, but also severe renal impairment (< 30 ml/min/1.73m2, see https://bnf.nice.org.uk/guidance/prescribing-in-renal-impairment.html), concomitant use of lithium, and thyroid disease (medically diagnosed hypo- or hyperthyroidism, thyroid cancer and/or use of thyroid medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bioburden in the index DFU, as measured by microbiological diagnostics at week 0, 6, 12, 18. The bacterial load will be quantified using the following formula: bacterial load (CFU/g) = (number of CFUs on plate ×103) / dilution. This will be performed for aerobic and anaerobic cultures. Any change at follow-up versus week 0 baseline figure will be calculated. In addition identify bacterial species and test antibiotic sensitivity. The bacterial species will be identified by standard microbiological techniques, including gram stain and microscopic examination, and trial specimen samples will be processed and analysed in the same microbiology laboratory where regular samples are sent, per Trust standard operating procedures. Levine’s technique will be applied for swabbing of the wound (Levine et al, 1976). Samples, taken with a sterile cotton swab and placed in containing charcoal transport medium, will be sent to the laboratory asap. Wound swabs should reach the laboratory on the day that they are taken, but in exceptional circumstances can be stored in a specimen fridge overnight. Specimens must not be left over the weekend or bank holidays. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wound size and characteristics, assessed at week 0, 3, 6, 9, 12 and 18: 1.1. Foot ulcer size, measured with Coloplast grid tool (week 0, 3, 6, 9, 12, 18), with week 18 being primary outcome measure. 1.2. Clinical characterisation of wound (incl. erythema, purulence, odour, plus depth) 1.3. PUSH and Texas Diabetes Foot Ulcer clinical severity score 1.4. Wound closure status and incidences of adverse events 1.5. Wound depth 2. Incidence of requirement to deviate from the randomised intervention arm due to significant deterioration or improvement in foot ulcer status, as determined by the treating clinician 3. Microbiological assessment of the diabetic foot ulcer (bacterial count and identification, antibiotic sensitivity) at week 0, 6, 12 and 18 4. Safety of applied dressing regimes (ongoing): 4.1. Wound infection incidence 4.2. Reaction to dressing 4.3. Need for secondary interventions (incl. need for surgery, admission to hospital, iv antibiotics) 5. Patient-reported outcome measures at week 0, 9 and 18: 5.1. Patient mobility measured using LifeSpace questionnaire 5.2. Wound-related quality of life measured using EQ-5D-5L and Cardiff Wound Impact Questionnaire 5.3. Pain associated with diabetic foot ulcer measured using Visual Analogue Score 6. Patient satisfaction of comfort and impact of dressing, measured using questionnaire at week 18 7. Feasibility of full RCT assessed using: 7.1. Number of eligible patients who consent to participating in the pilot trial 7.2. Recruitment to planned schedule and timelines. 7.3. Withdrawal rates 7.4. Attrition rates | — |
Countries
England, United Kingdom
Outcome results
None listed