Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation.

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.

Amputation considerations and energy expenditures in the diabetic patient.

Amputations are not procedures of choice but are often necessary and valuable tools for returning a patient to a more active lifestyle. Because of the comorbidities associated with diabetes, this is an important consideration. A return to a more active existence can reduce the effect of vascular disease, hyperglycemic states, and functional limitations. It is an interesting and not uncommon occurrence for the chronic wound patient, when offered an amputation, to have the procedure because the frequency of needed medical care has stripped him of his independence. The frequency of wound care in the nonhealing wound and its personal demands can be compared with the demands placed on the dialysis patient. The greatest obstacle for the uninitiated surgeon is a sense of hesitancy: Am I moving too fast to amputation as an answer? The ability to make this decision comes with experience and with prioritizing the patient's needs. Life-threatening infections and avascular extremities that are not bypassable are the easier decisions to make, as there is little choice at that point. In deciding whether to amputate, the wise surgeon will take into consideration the medical and mobility needs of each patient and determine level and timing based on understanding of the whole person.

Mortality of first-time amputees in diabetics: a 10-year observation.

AIMS: We analyze mortality of first-time diabetic amputees by stratifying by level of amputation, differentiating short-term and long-term mortality. METHODS: We evaluated 277 diabetic patients who received their first lower extremity amputation (LEA) during 1993-97. Subjects were followed until December 2003, and categorized by level of amputation. We compared the mortality difference by level for 0-10 years, 0-10 months, and 10 months-10 years, and examined the association of comorbid conditions and death for each level. RESULTS: We found a significant difference in mortality by amputation level for 0-10 years (p<0.05) and <10 months (p<0.01) survival, but not for the one of 10 months-10 years. For major amputees deceased within 10 months, sepsis was as frequent a cause of death as cardiovascular disease. In distal amputees, CVD, CAD and ESRD were strongly associated with death, but only CAD was associated death among major amputees. CONCLUSION: For diabetic patients undergoing first LEAs, the mortality of major amputees was worse than that of minor amputees due to the difference in first 10-month mortality. The history of comorbid conditions in first-time major amputees was less important than in minor amputees since sepsis was the frequent cause of death in major amputees in this early period.

Thrombin peptide Chrysalin stimulates healing of diabetic foot ulcers in a placebo-controlled phase I/II 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.