Author/year Number of patients Age Patient selection Definition of healing Healing rate Healing time Follow-up Factors related to outcome Mortality Comments Walsh et al 2013120 10 64 (50-83) (DM) 77 (50-87) (non DM) Diabetes + non diabetes Yes 8/10 (5/7 in DM patients) 64 days (mean) 3 years Not reported 0% Case series of efficacy of calcanectomy. Small patient sample. Shojaiefard et al 2013115 37 62 ±14 Diabetes No 89% 6 (4-7) months Minimum 1 year Not reported 0% 11% major amputation Oliver et al 2015121 42 61±16.6 64±16 Diabetes + non diabetes No Not reported Not reported 41±26 months Not reported 12% Study on partial calcanectomy for heel ulcers. Question is whether resection of more or less than 50% of calcaneus has an influence on outcome. It does not. 29% major amputation. Yosuf et al 2015122 50 (cohort 100 patients) 52.9±11 Diabetes Yes 54% 20 Not specified Not reported 0% from Sudan. Compares outcome of forefoot ulcers vs heel ulcers. Kallio et al 2015117 63 56 (range 21) Diabetes Yes 84% 56% 33% 1991-2003 6 years Smoking, heel nephropathy, ulcer diameter >10 cm associated with increased amputation risk 3% (30 day mortality) Studies free flap transfer for heel ulcers. Amputation rate 11% (30 day amp rate). 30% major amputation during follow-up. Lin et al 2016116 12 73 (65-79) Diabetes No 75% Not reported 2 weeks to 3 years Not reported 8% Included patients with near total occlusive PVD. Primary wound closure in all cases. Örneholm et al 2016Paper III 768 73 (17-98) Diabetes Yes 66% 17 (1-416) weeks Until healing or death Vascular surgery, nephropathy, oedema, creatinine <91 µmol/L 25% 12% major amputation
BKA (14) or Syme (1) Van Damme et al 200186 146 Diabetes 186 amp Minor and major 1993-1998 Not reported 66 (mean age) Neuropathic toe amp: 14% Neuropathic midfoot amp: 9% re-amputation toe amputation: 28% Neuro-ischaemic midfoot amp: 25% re-amputation Dalla Paola et al 2003145 89 Diabetes 65/89 healed by first intention. The remaining 24 healed after dressings. Minor (first ray amputations) 16±7 months Not reported 66±9 17% ulcer recurrence during follow-up. 8% re-amputation (no major amputation). Sheahan et al 2005134 670 Diabetes + non diabetes (all had PVD) Limb salvage 89.8% at 1 year Minor only 47.3 months ESRD, transmetatarsal amputation (initial amputation), and subsequent revascularization were factors related to limb loss. Not reported Not reported Mortality 16% at 1 year. Berceli et al 2006136 165 Diabetes + non diabetes 208 forefoot amputations. Closed amputation; 86% healed Staged amputation; 91% healed Open amputation; 70% healed Minor only 2 Renal insufficiency Not reported 25% Uzzaman et al 2011195 126 Diabetes + non diabetes Not reported Minor only Not reported Not reported 75±12.9 (DM) 80.5±14.8 (non DM) Not reported Retrospective 5 year mortality 27% van Battum et al 2011166 194 Diabetes 18% of EURODIALE cohort underwent minor amputation. Minor 1 year Depth of ulcer, PVD, infection, and male sex predicted minor amputation. 65.2±11.6 Not reported Analysis of subgroup in the EURODIALE cohort. The rate of minor amputations
75% healing rate in minor amputations. differed between centres (2.4-34%). One explanation is the difference in disease severity at presentation. Author/year Number of patients Patient selection Outcome Amputation level Follow-up Factors related to outcome Age Re-amputation rate Comments Kono et al 2012169 116 Diabetes + non diabetes Not reported Minor only 3 years Insulin dependent diabetes and gangrene were risk factors for 66.8±11 57/116 Retrospective (single hospital, veterans) 5 year mortality 46% Borkosky et al 2013156 59 Diabetes 100% only 33.8 months Not reported 63 (39-97) 42.4% new amputations on same site during study period Retrospective chart evaluation. Mortality 47.5% at final chart review. Caruana et al 2015157 50 Diabetes 28/50 healed/is healing (at 6 weeks follow-up) Minor only 6 weeks Toe pressure was higher in patients healed/healing 67.4 (mean age) Not reported of study is on whether ankle brachial pressure index or toe pressure or ankle waveforms are better to predict healing after minor amputation. Matsuzaki et al 2015194 66 Diabetes (all patients have nephropathy, PTA and amputation) Main outcome mortality, healing rate not reported 56 10 major Not reported Not reported 68±11 Not reported 2 year mortality 41% (minor amp) (major amp) Wiessman et al 2015196 565 Diabetes Not reported All amputation levels and major, both above and below knee) 35 months Not reported 68±12 Not reported Primary study focus was one-year mortality. 1-year mortality 35.8% (all patients regardless of amputation level) Beaney et al 2016168 165 Diabetes 33/165 (20%) underwent 34 amputations (17 major, 17 minor) Minor and major Minimum 1 year Factors related to amputation: less than 100% attendance, poor glycemic control, hypertension. Previous vascular surgery and low comorbidity <50 y: 28 50-54 y: 14 55-64 y: 29 65-74 y: 46 ≥75 y: 49 Not reported Retrospective Case analysis of patients referred to diabetic foot clinic
associated with lower amputation risk Chu et al 2016158 245 Diabetes 82.4% healed Minor 5 years Not reported 69±9 17.5% (1 year) 22.3% (3 year) 47.1% (5 year) Risk factors for male gender, age >70 HbA1c >9%. aim was to evaluate re-ulceration, re-amputation and mortality. Mortality; 5.8% (1 year) 15.1% (3 year) 32.7% (5 year) Re-ulceration 76.4% in 5 years. Risk factors; ischemia, great toe amputation, HbA1c >9%. Malyar et al 2016193 40335 DFS 17.3% PAD + DM 21.5% PAD 61.2% Not reported Minor and major Maximum 4 Not reported 70±12 DFS 72±10 PAD+DM 71±12 PAD Major 7% (DFS), 12% (PAD+DM), 9.5% (PAD). Minor 19% (DFS), 12% (PAD+DM), 12% (PAD). Study based on German register of health insurance. 4 year mortality: 30% (DFS) 39% (PAD+DM) 52% (PAD) Mandolfino et al 2016165 218 Diabetes + non diabetes 64% healed Transmetatarsal 2008-2013 Not reported Mean 67 years 33% 1 year mortality 8% Aim of study was to define role and timing of vascular surgery Wilbek et al 2016197 777 Diabetes Not reported 1231 minor amputations 1996-2013 Not reported 56 (27-83) DM type 1 men 52 (23-93) DM type 1 women 66 (35-91) DM type 2 men 71 (35-97) DM type 2 women Not reported Retrospective 5 year mortality: Type 1 DM 43%, Type 2 DM 52%