Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study.

This 12-week, prospective, randomised, controlled multi-centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty-six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre-treatment ulcer data were calculated. Complete healing and mean healing time were 69.6% and 5.7 weeks, respectively, for the study group and 46.2% and 6.8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (P = 0.0289), with odds of healing in the study group 2.7 times higher than in the control group. Kaplan-Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate (P = 0.015) for the control group (53.9%) compared with the study group (30.4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (P = 0.0194), a statistically significant difference in non healing rate between groups was calculated (P = 0.0233), with odds of healing 2.0 times higher in the study versus control group. This study supports the use of single-application AM therapy as an effective treatment of diabetic, neuropathic ulcers.

External fixation indications and patient selection.

Since its modest beginnings in the mid-nineteenth century, external fixation has seen great changes in its design and application. Once thought of as chiefly a fracture management tool, this modality has found its way into the arenas of corrective osteotomies, Charcot management, limb lengthening, nonunion treatment, and malalignment correction. As external fixation has evolved, great improvements in associated complications have also occurred. This is attributed to evolving frame design, subsequent increased stability, and advances in pin/wire insertion techniques. Paley and Herzenberg describe three factors to consider when evaluating whether to use external or internal fixation [2]. 1. Risk versus benefit of the method used for that specific indication. 2. Surgeon's experience with the specific method. 3. Ability to treat the potential complications of the surgery. The authors agree with these factors but would also include psychological tolerance, compliance with postoperative self-treatment, and personal hygiene. In this article the indications for external fixation were described in terms of pathology and individual patient factors were discussed for the surgeon's consideration. The surgeon must consider the patient's bone quality, age, cognitive ability, psychological tolerance, and compliance level. With these factors kept in mind and evaluated appropriately, the surgeon should be able to select the patient and indications for which external fixation will yield a superior result.