DESIGN ISSUES OF A RANDOMIZED CONTROLLED CLINICAL-TRIAL ON SPINAL-CORD STIMULATION IN CRITICAL LIMB ISCHEMIA

Objectives: Review of the design of a clinical study to evaluate of th e efficacy of epidural spinal cord electrical stimulation (ESES) as co mpared to best medical treatment in patients with nonreconstructible c ritical limb ischaemia. Design: Randomised controlled clinical trial o f pragmatic type, which will be analysed according to the intention-to -treat principle. The treatment strategies are ESES, in addition to be st medical treatment, and best medical treatment alone. Patients are f ollowed-up for at least 18 months. Setting: The ESES-trial is ongoing multicentre trial in 17 hospitals in The Netherlands. Patients: Patien ts with critical limb ischaemia, nonsuitable for either primary interv ention or reintervention after failing reconstructions. Chief outcome measures: Limb survival, patient survival, quality of life and cost-ef fectiveness. Main results: From November 1991 until May 1994 120 patie nts had been enrolled. Using life-table analysis, at one year 76% of t hese randomised patients were alive: 41% without amputation and 35% wi th amputation. Quality of life of the trial patients was low, even com pared to other severely ill patient groups, such as liver and heart tr ansplant candidates. Conclusions: Considering the high incidence of de ath and amputation, 18 months of follow-up seems adequate to detect a clinically relevant outcome improvement from ESES-treatment, if presen t. We hope to present the results of this study at the end of 1995.