Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Below-knee amputation for ischaemic gangrene. Prospective, randomized comparison of a transverse and a sagittal operative technique. One-stage versus two-stage amputation for wet gangrene of the lower extremity: a randomized study. Prevention of amputation by diabetic education. Continuous postoperative infusion of a regional anesthetic after an amputation of the lower extremity. A randomized clinical trial. Transcutaneous oxygen pressure as predictive parameter for ulcer healing in endstage vascular patients treated with spinal cord stimulation. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Pre-operative shaving and wound infection in appendectomy. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study.
The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients.
                We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889.
                The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy.
                In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty. In a prospective, randomized study a comparison was made of the results of primary below-knee amputation for ischaemic gangrene carried out by two methods: In 47 cases by the transverse technique with a long posterior musculo-cutaneous flap and in 41 cases by the sagittal technique using equally large medial and lateral musculo-cutaneous flaps--in both instances followed by 2 weeks in a half-open plaster cast with extended knee. The sex ratio and age distribution were the same in both groups. Minor differences in the vascular condition between the groups, assessed by the duration of rest pain, pulsation findings, extent of gangrene, and frequency of diabetes, wholly or partially equalized each other. The course of healing was the same in both groups, primary healing being attained in 38 per cent and 41 per cent, respectively (0.70 less than P less than 0.80). There was also no difference between the results as regards limb fitting, ambulation, occupational, or social status. It is concluded that the choice between the two methods can be based merely upon surgical skill and the ischaemic changes in the lower leg. Although the two-stage amputation technique entails an additional operation, several authors have advocated this approach to deal with wet gangrene because it allows primary wound closure with a reduced chance of wound infection. To examine this issue, 47 patients with necrotizing wet gangrene of the foot were randomized prospectively to receive either a one-stage amputation (definitive below- or above-knee amputation with delayed secondary skin closure in 3 to 5 days) or a two-stage amputation (open ankle guillotine amputation followed by definitive, closed below- or above-knee amputation). Antibiotic coverage was standardized with clindamycin and gentamicin used in all patients. Preoperative blood cultures and intraoperative foot cultures were obtained, as well as cultures from the deep muscle and lymphatic area along the saphenous vein to determine the presence of bacteria at the level of initial amputation. Twenty-four patients (11 diabetic and 13 nondiabetic) were randomized to the one-stage procedure. Twenty-three patients (14 diabetic and nine nondiabetic) were randomized to the two-stage procedure. Five of 24 patients in the one-stage group (21%) had positive muscle cultures vs 10 of 23 patients in the two-stage group (43%). Two of 24 patients in the one-stage group (8%) had positive lymphatic cultures vs 7 of 23 patients in the two-stage group (30%). Five of 24 patients in the one-stage group (21%) had wound complications attributable to the amputation technique vs none of 23 patients in the two-stage group (p = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS) This prospective randomized study evaluated the influence of a simple education program on the incidence of lower extremity amputation in diabetic patients. Two hundred three patients were randomized into two groups: Group 1, education (103 patients, 203 limbs) and Group 2, no education (100 patients, 193 limbs). There were no significant differences in medical management or clinical risk factors between the two groups. The amputation rate was three times higher in Group 2 (21 of 177 limbs versus 7 of 177 limbs; p less than or equal to 0.025), the ulceration rate was three times higher in Group 2 (26 of 177 limbs versus 8 of 177 limbs; p less than or equal to 0.005), and there was no difference in the overall incidence of infection (2 of 177 limbs). Overall success in Group 1 was highly significantly different from Group 2 (160 of 177 limbs versus 128 of 177 limbs; p less than or equal to 0.0005). This study demonstrated that a simple education program significantly reduced the incidence of ulcer or foot and limb amputation in diabetic patients. We performed a prospective, randomized clinical trial to determine whether continuous infusion of bupivacaine hydrochloride decreased the use of narcotics for the relief of pain after an amputation. Twenty-one patients who were to have an amputation of the lower extremity because of ischemic necrosis secondary to peripheral vascular disease were divided into two groups with use of a table of random numbers. Group A (the treatment group) included nine patients who were to have a transtibial amputation, one patient who was to have a disarticulation at the knee, and one patient who was to have a transfemoral amputation. Group B (the control group) included seven patients, two patients, and one patient, respectively. After the amputation had been performed, a Teflon catheter was placed adjacent to the transected end of the sciatic or posterior tibial nerve. Postoperatively, the patients received continuous infusion of either bupivacaine (Group A) or normal saline solution (Group B) for seventy-two hours. Intravenous administration of morphine with use of a patient-controlled pump also was permitted during this period. The amount of morphine that was used was recorded meticulously. The patients in Group A used less morphine during the first and second days after the operation than did those in Group B. There was no difference between the groups with regard to the amount of morphine used on the third postoperative day. Over-all, eleven of fourteen patients who completed questionnaires reported a decrease in pain between the three and six-month evaluations. We concluded that continuous perineural infusion of an anesthetic appears to be a safe, effective method for the relief of postoperative pain but that it does not prevent residual or phantom-limb pain in patients who have had an amputation of the lower extremity because of ischemic changes secondary to peripheral vascular disease. This study was designed to test the hypothesis that initial TcPO2 helps predict clinical outcome in vascular patients treated with spinal cord stimulation. A randomized-controlled study with one year follow-up was made in 86 Fontaine stage IV patients with endstage peripheral arterial occlusive disease (PAOD) undergoing 21 day intravenous prostaglandin E1 (PGE1) therapy for nonhealing ulcers.
                All patients had arteriosclerosis, 13 also diabetes mellitus. Entry criteria included: non-reconstructible PAOD as proven by intra-arterial angiography or patient condition, ankle systolic pressure < 50 mmHg, severe rest pain despite analgetic medication, and presence of nonhealing foot ulcers or dry gangrene. One week after the start of PGE1 therapy, patients were randomized into receiving SCS plus PGE1 (n = 45 patients), or just PGE1 (n = 41 patients). Follow-up examinations were done at 1, 3, 6 and 12 months. BASELINE: There were no significant differences between both groups in the following: age, sex distribution, ischemic skin lesions, risk factors and several key group mean physiological values including ankle systolic pressure, ankle/brachial ratio (ABI) and foot TcPO2. The SCS group had more prior vascular leg surgeries (1.77 vs 1.58 per patient). RESULTS AT 12 MONTHS: There was significantly better total healing of foot ulcers in the SCS-group (69 vs 17%; p < 0.0001). Significantly more SCS-patients achieved an outcome of Fontaine stage II (claudication pain, no rest pain or lesions) (40 vs 10%, p = 0.0014). The frequency of minor and major amputations was not different, respectively 13 vs 15% and 16 vs 20%. The mean ABI at 12 months of the treated limb of the SCS-patients was not significantly greater. Foot TcPO2 increased significantly for the SCS-group (+213 vs -2%; p < 0.0001). Patients in either group whose TcPO2 rose to 26.0 +/- 8.6 mmHg on average were able to heal ulcers or toe amputation wounds. PGE1-patients had temporary TcPO2 elevations of about 33% on average but this was gone by six months. SCS-patients had steady increases in TcPO2, and maintained them at 12 months. Among the SCS-patients, those with baseline TcPO2 < = 10 mmHg had significantly less success at 12 months, this was not observed for the OMT-patients. The regional perfusion index increased significantly, 187 vs 0%; p < 0.001.
                Spinal cord stimulation appears to provide a major benefit for lesion improvement in stage IV patients with non-reconstructible PAOD. Patients with an initial TcPO2 > 10 mmHg will respond better to the stimulation therapy. With pain relief and ulcer healing quality of life improved. Effects on limb salvage do not appear. To assess the application of autologous transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood mononuclear cells (PBMNCs) in the treatment of critical limb ischemia (CLI) of diabetic patients and to evaluate the safety, efficacy, and feasibility of this novel therapeutic approach.
                Twenty-eight diabetic patients with CLI were enrolled and randomized to either the transplant group or the control group. In the transplant group, the patients received subcutaneous injections of recombinant human G-CSF (600 microg/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were collected and transplanted by multiple intramuscular injections into ischemic limbs. All of the patients were followed up after at least 3 months.
                At the end of the 3-month follow-up, the main manifestations, including lower limb pain and ulcers, were significantly improved in the patients of the transplant group. Their laser Doppler blood perfusion of lower limbs increased from 0.44 +/- 0.11 to 0.57 +/- 0.14 perfusion units (P < 0.001). Mean ankle-brachial pressure index increased from 0.50 +/- 0.21 to 0.63 +/- 0.25 (P < 0.001). A total of 14 of 18 limb ulcers (77.8%) of transplanted patients were completely healed after cell transplantation, whereas only 38.9% of limb ulcers (7 of 18) were healed in the control patients (P = 0.016 vs. the transplant group). No adverse effects specifically due to cell transplantation were observed, and no lower limb amputation occurred in the transplanted patients. In contrast, five control patients had to receive a lower limb amputation (P = 0.007, transplant vs. control group). Angiographic scores were significantly improved in the transplant group when compared with the control group (P = 0.003).
                These results provide pilot evidence indicating that the autologous transplantation of G-CSF-mobilized PBMNCs represents a simple, safe, effective, and novel therapeutic approach for diabetic CLI. The study on the effects of shaving the skin on wound infections after appendectomy was done in 80 patients in 1988 in Siriraj Hospital. Patients were divided randomly into two groups, 40 patients each, a control and an experiment group. The control group had their skin shaved and the experiment group did not. Data showed no difference in: demography, preoperative admission time, interval between skin preparation and surgery, thickness of subcutaneous tissue, operating time, and suture materials. Shaving of the skin resulted in no alteration in bacteria found on the skin, on the walls of the wound before closing. Stitch abscesses were the only wound infection found in 3 patients in each group. It is concluded that skin shaving, though it did not increase wound infection rate, had no beneficial effect on wound infection in appendectomy. This study was designed to test the hypothesis that spinal cord stimulation (SCS) improves limb salvage in patients with inoperable severe leg ischaemia.
                Prospective randomised controlled study with 18 months follow-up.
                Vascular surgical units in two university hospitals.
                Atherosclerotic (n = 41) and diabetic (n = 10) patients having chronic leg ischaemia with rest pain and/or ischaemic ulcerations due to technically inoperable arterial occlusions.
                Limb salvage and amount of tissue loss within 18 months, pain relief.
                Twenty-five patients were randomized to SCS and 26 to analgesic (control) treatment. Macrocirculatory parameters were not different in the two groups during follow-up. Long-term pain relief was observed only in the SCS group. At 18 months, limb salvage rates in the SCS and control groups were 62% and 45% (N.S.). Tissue loss was less (p = 0.05) in the SCS group. A subgroup analysis of patients without arterial hypertension showed a significantly lower amputation rate in the SCS vs the control group.
                SCS provided long-term pain relief but limb salvage at 18 months was not significantly improved by SCS in this rather small study. The results suggest that SCS may reduce amputation levels in patients with severe inoperable leg ischaemia and be most effective in patients without arterial hypertension.
Evidence suggests that the choice of amputation technique has no effect on outcome and can, therefore, be a simple matter of surgeon preference. Factors which might influence this include previous experience of a particular technique, the extent of non-viable tissue, and the location of pre-existing surgical scars.