None listed
Conditions
Brief summary
One Australian loses a limb every 3 hours as a result of diabetic foot ulcers (DFU) with infection. This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for WA Health and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. A novel intervention towards achieving these goals is the use of spray-on skin for patients with DFU. The application of ‘spray-on’ autologous skin grafting aids epithelial regeneration and wound healing and has been used successfully for the treatment of burns to improve healing. In this research project we will compare spray-on skin with standard care in an open label randomised controlled trial in patients presenting to hospital with DFU. We hypothesise that spray-on skin will shorten the time for the ulcer to heal completely. In doing so, this approach can be expected to prevent amputations and recurrent ulceration whilst improving quality of life. Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges.
Interventions
The application of autologous skin cells in a suspension (Spray on skin) is the intervention. This is achieved using a proprietary product (ReCell® Avita Medical), a pre-prepared kit for autologous cell skin cell preparation. Through a series of well described enzymatic preparation and cell filtering steps, the procedure enables disaggregation of cells from a patient’s skin sample and the preparation of a suspension of these cells that can be sprayed or dropped directly onto the prepared wound b
The application of autologous skin cells in a suspension (Spray on skin) is the intervention. This is achieved using a proprietary product (ReCell® Avita Medical), a pre-prepared kit for autologous cell skin cell preparation. Through a series of well described enzymatic preparation and cell filtering steps, the procedure enables disaggregation of cells from a patient’s skin sample and the preparation of a suspension of these cells that can be sprayed or dropped directly onto the prepared wound bed. The procedure to harvest, prepare and administer skin cells will be performed once only by a vascular or plastic surgeon. The skin from which the suspension is prepared comes from a small split skin graft (SSG) that is taken from the patients’ thigh using topical local anaesthetic . An electric dermatome set at 2mm depth with a standard width will be used to harvest the skin and will enable accurate assessment of the area of the harvest site. The entire procedure will take ~30 minutes. Each patient will receive a single administration of cells harvested on a single occasion. The total number of cells administered (ie dose) is not quantifiable but will be all of the cells harvested from a 2cm2 piece of skin.
Sponsors
Department of Health Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) Age greater than 18years ii) Diabetes (type 1 or 2) defined according to international consensus guidelines iii) Admission to FSH or visit to outpatients department at FSH with a DFU requiring local debridement or minor amputation iv) Ulcer area greater than or equal to 6cm2 v) The ulcer location, contour, shape and wound base is deemed to be suitable for administration of spray on skin vi) No further debridement or amputation is anticipated vii) Wound bed is adequately vascularised as determined by the presence of at least one palpable pulse in the affected foot, or at least single vessel run off visualised by arterial Doppler ultrasonography, MRI, CT or conventional angiography (including following revascularisation procedures) viii) Competent and willing to provide informed consent ix) Able to be followed up by Silver Chain for community nursing
Exclusion criteria
i) Non-diabetic neuropathic ulcer ii) Wounds deemed unsuitable on the basis of contour, location, vascularity or other factors iii) Limb threatening ischaemia or sepsis requiring early major amputation iv) Not competent to provide informed consent v) Unlikely to be accessible for follow-up visit over the next 12 months vi) Unable to be followed up by Silver Chain ambulatory care nurses
Outcome results
None listed