ABSTRACT
There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or standard care interventions for large (>6 cm2 ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm2 . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).
Subject(s)
Diabetes Mellitus , Diabetic Foot , Amputation, Surgical , Australia , Diabetic Foot/surgery , Humans , Skin Transplantation , Wound HealingABSTRACT
In a study of the effects of type 2 diabetes and schizophrenia on mortality in 1296 community-based diabetic patients followed for a mean±SD 12.9±6.1years and in 5159 matched non-diabetic residents, 0.4% of each group had schizophrenia. Patients with both conditions had a six-fold adjusted increased risk of death.