OBJECTIVE -This study examined the risk of reamputation, stratified by original level of amputation, in a population of diabetic patients. We also illustrated reamputation rates by ipsilateral and contralateral limbs.RESEARCH DESIGN AND METHODS -The study population included 277 diabetic patients with a first lower-extremity amputation performed between 1993 and 1997 at University Hospital in San Antonio, Texas. Reamputation episodes for the ipsilateral and contralateral limbs were recorded through 2003. Using a cumulative incidence curve analysis, we compared the reamputation rate by limb. Cumulative rates of reamputation were calculated for each limb at each amputation level at 1, 3, and 5 years.RESULTS -Cumulative rates of reamputation per person were 26.7% at 1 year, 48.3% at 3 years, and 60.7% at 5 years. Ipsilateral reamputation per amputation level at the 1-, 3-, and 5-year points were toe: 22.8, 39.6, and 52.3%; ray: 28.7, 41.2, and 50%; midfoot: 18.8, 33.3, and 42.9%; and major: 4.7, 11.8, and 13.3%. For contralateral reamputation, the rates at 1, 3, and 5 years were toe: 3.5, 18.8, and 29.5%; ray: 9.3, 21.6, and 29.2%; midfoot: 9.4, 18.5, and 33.3%; and major: 11.6, 44.1, and 53.3%.CONCLUSIONS -This study showed that a patient is at greatest risk for further same-limb amputation in the 6 months after the initial amputation. Although risk to the contralateral limb rises steadily, it never meets the level of that of the ipsilateral limb. This finding will help clinicians focus preventive efforts and medical resources during individualized at-risk periods for diabetic patients undergoing first-time amputations. Diabetes Care 29:566 -570, 2006F oot ulcers and lower-extremity amputations (LEAs) are disabling complications of diabetes that can lead to significant increases in mortality and morbidity (1,2), most notably recurrent amputation at increasingly higher levels. It has been shown that a history of ulceration increases the risk of amputation (3,4), as do prior amputations (4). Several studies have reported reamputation rates (5-15). However, the results of these studies are too general to apply to individual patients; some studies combined reamputation episodes of both ipsilateral and contralateral limbs (5-7) and others addressed reamputation of only one extremity (8 -10). Reamputations at specific levels have been studied (11-15), but how the rates differ by level of amputation is still unknown. In addition, many of these studies included reamputations for patients with existing amputations. The true reamputation rate of first-time amputations has not been reported before this study.In this retrospective cohort study, we aimed to 1) illustrate the difference between the reamputation risk for ipsilateral and contralateral limbs and 2) stratify the risk of reamputation by the original level of amputation. With these findings, we hope to help clinicians estimate individualized risk for patients based on the level of first-time amputation.RESEARCH DESIGN AND METHODS -In this retrospective cohort study,...
Thrombin and thrombin peptides play a role in initiating tissue repair. The potential safety and efficacy of TP508 (Chrysalin) treatment of diabetic foot ulcers was evaluated in a 60-subject, prospective, randomized, double-blind, placebo-controlled phase I/II clinical trial. Chrysalin in saline or saline alone was applied topically, twice weekly, to diabetic ulcers with standardized care and offloading. A dose-dependent effect was seen in the per-protocol population where 1 and 10 mug Chrysalin treatment resulted in 45 and 72% more subjects with complete healing than placebo treatment. Chrysalin treatment of foot ulcers more than doubled the incidence of complete healing (p<0.05), increased mean closure rate approximately 80% (p<0.05), and decreased the median time to 100% closure by approximately 40% (p<0.05). Chrysalin treatment of heel ulcers within this population resulted in mean closure rates 165% higher than placebos (p<0.02) and complete healing in 86% (6/7) of ulcers compared with 0% (0/5) of placebo ulcers (p<0.03). Local wound reactions and adverse events (AEs) were equal between groups with no reported drug-related changes in laboratory tests or serious AEs. These results indicate the potential safety and efficacy of Chrysalin for treatment of diabetic foot ulcers.
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