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One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector 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.
One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed ‘spray-on’ skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed.
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. Shortened healing times may enable participants to return to work earlier. 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.
Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.
Australian Institute of Health and Welfare. Diabetes: Australian facts 2008. In: AIHW C, editor 2008.
Bergin SM, Alford JB, Allard BP, Gurr JM, Holland EL, Horsley MW, et al. A limb lost every 3 hours: can Australia reduce amputations in people with diabetes? Med J Aust. 2012;197(4):197–8. CrossRef
Dillon MP, Fortington LV, Akram M, Erbas B, Kohler F. Geographic variation of the incidence rate of lower limb amputation in Australia from 2007-12. PLoS One. 2017;12(1):e0170705. CrossRef
Dillon MP, Kohler F, Peeva V. Incidence of lower limb amputation in Australian hospitals from 2000 to 2010. Prosthetics Orthot Int. 2014;38(2):122–32. CrossRef
Kurowski JR, Nedkoff L, Schoen DE, Knuiman M, Norman PE, Briffa TG. Temporal trends in initial and recurrent lower extremity amputations in people with and without diabetes in Western Australia from 2000 to 2010. Diabetes Res Clin Pract. 2015;108(2):280–7. CrossRef
Baba M, Davis WA, Norman PE, Davis TM. Temporal changes in the prevalence and associates of diabetes-related lower extremity amputations in patients with type 2 diabetes: the Fremantle diabetes study. Cardiovasc Diabetol. 2015;14:152. CrossRef
Payne CB. Diabetes-related lower-limb amputations in Australia. Med J Aust. 2000;173(7):352–4. CrossRef
Lazzarini PA, Hurn SE, Kuys SS, Kamp MC, Ng V, Thomas C, et al. Direct inpatient burden caused by foot-related conditions: a multisite point-prevalence study. BMJ Open. 2016;6(6):e010811. CrossRef
Huang Y-Y, Lin C-W, Yang H-M, Hung S-Y, Chen IW. Survival and associated risk factors in patients with diabetes and amputations caused by infectious foot gangrene. J Foot Ankle Res. 2018;11:1. CrossRef
Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019;19(1):1. CrossRef
Moulik PK, Mtonga R, Gill GV. Amputation and Mortality in New-Onset Diabetic Foot Ulcers Stratified by Etiology. Diabetes Care. 2003;26(2):491–4. CrossRef
Jupiter DC, Thorud JC, Buckley CJ, Shibuya N. The impact of foot ulceration and amputation on mortality in diabetic patients. I: from ulceration to death, a systematic review. Int Wound J. 2016;13(5):892–903. CrossRef
Cheng Q, Lazzarini PA, Gibb M, Derhy PH, Kinnear EM, Burn E, et al. A cost-effectiveness analysis of optimal care for diabetic foot ulcers in Australia. Int Wound J. 2017;14(4):616–28. CrossRef
Norman PE, Schoen DE, Gurr JM, Kolybaba ML. High rates of amputation among indigenous people in Western Australia. Med J Aust. 2010;192(7):421. CrossRef
West M, Chuter V, Munteanu S, Hawke F. Defining the gap: a systematic review of the difference in rates of diabetes-related foot complications in aboriginal and Torres Strait islander Australians and non-indigenous Australians. J Foot Ankle Res. 2017;10:48. CrossRef
Driver VR, Fabbi M, Lavery LA, Gibbons G. The costs of diabetic foot: the economic case for the limb salvage team. J Am Podiatr Med Assoc. 2010;100(5):335–41. CrossRef
Jeffcoate WJ, Chipchase SY, Ince P, Game FL. Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. Diabetes Care. 2006;29(8):1784–7. CrossRef
Ndosi M, Wright-Hughes A, Brown S, Backhouse M, Lipsky BA, Bhogal M, et al. Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. Diabet Med. 2018;35(1):78–88. CrossRef
De Angelis B, Migner A, Lucarini L, Agovino A, Cervelli V. The use of a non cultured autologous cell suspension to repair chronic ulcers. Int Wound J. 2015;12(1):32–9. CrossRef
Chant H, Woodrow T, Manley J. Autologous skin cells: a new technique for skin regeneration in diabetic and vascular ulcers. J Wound Care. 2013;22(10 Suppl):S10–5.
Smith-Strom H, Iversen MM, Igland J, Ostbye T, Graue M, Skeie S, et al. Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: a retrospective cohort study. PLoS One. 2017;12(5):e0177176. CrossRef
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. CrossRef
Van Netten JJ, Bus SA, Apelqvist J, Lipsky BA, Hinchliffe RJ, Game FL, et al. Definitions and criteria for diabetic foot disease. IWGDF Guidelines. 2019.
Sothornwit J, Srisawasdi G, Suwannakin A, Sriwijitkamol A. Decreased health-related quality of life in patients with diabetic foot problems. Diabetes Metab Syndr Obes. 2018;11:35–43. CrossRef
Pickwell KM, Siersma VD, Kars M, Holstein PE, Schaper NC. Eurodiale c. diabetic foot disease: impact of ulcer location on ulcer healing. Diabetes Metab Res Rev. 2013;29(5):377–83. CrossRef
Lu SH, McLaren A-M. Wound healing outcomes in a diabetic foot ulcer outpatient clinic at an acute care hospital: a retrospective study. J Wound Care. 2017;26(Sup10):S4–S11. CrossRef
Mills JL, Sr., Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, et al. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014;59(1):220–234 e1–2. CrossRef
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. CrossRef
Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. 2005;366(9498):1695–703. CrossRef
Reynolds T. Clinical trials: can technology solve the problem of low recruitment? BMJ. 2011;342:d3662. CrossRef
- Spray on skin for diabetic foot ulcers: an open label randomised controlled trial
Emma J. Hamilton
Paul E. Norman
Jens C. Ritter
- BioMed Central