現今社會日常生活型態的改變以及人口老化趨勢，導致全球第二型糖尿病之盛行率急劇增加。糖尿病為一種很複雜的疾病，隨著高血糖和蛋白糖化的進展促使急性及慢性併發症的產生。糖尿病足為非常嚴重的慢性併發症，包括神經性病變、血管病變，及血管合併神經性病變三大類型，其最後的結果皆會因血循灌流不足進而造成足部組織壞死甚至截肢。糖尿病足在早期發生的時候並不容易診斷，病人常因足部產生潰瘍，傷口不易癒合才來就診，此時足部可能已經產生不同程度的血循病變。臨床上，糖尿病患合併足部血循病變的時候，非侵入性的理學檢查扮演著早期篩檢的角色，但其精確度及信賴度經常被質疑。雖然最先進血管攝影可提供精確的足部血循供應診斷，但為侵入性且相當昂貴於第一線篩檢有較大的困難性。因此發展非侵入性及實惠的創新性診斷糖尿病足血循病變檢測方法成為目前相當重要及極具挑戰性的研究課題。

本研究的目的為研發實惠的創新性皮膚表面溫度量測用於診斷糖尿病足之血循病變，以達到早期診斷及早期治療進而限制殘障及續發疾病的目標。其特定目標為： （1）探討前足踝、足背、足底內側、足底外側、足跟和足踝外側的皮膚表面溫度分佈形態;（2）發展皮膚表面溫度測量檢測糖尿病足循環障礙的臨床檢測流程(Protocol)；（3）評估此表面溫度檢測方法的準確性。足踝血管供應區(angiosomes)與血流於皮膚表面溫度之間的相關性提供本研究發展的理論基礎。本研究實驗分為兩個階段:第一階段受測者為五十位正常人(男女各25位，年齡46.1±7.8歲)與一百位糖尿病患(男女各50位，年齡61.3±9.4歲)，所有受測者皆通過IRB於義大醫院及中國醫藥大學附設醫院，經由血管杜普勒感測器來定位前足踝、足背、足底內側、足底外側、足跟和足踝外側六個血管供應區塊，並利用高感度遠紅外線溫度感測器量測此六個供應區塊的皮膚表面溫度。分析表面溫度與血循病變之關聯性，推導出最具代表性區塊足背與足底內側表面溫度診斷流程(DPTR)。第二階段利用DPTR診斷糖尿病患者(其中糖尿病無足部血循病變19人，年齡52.1±5.2歲；糖尿病合併足部血循病變81人，年齡61.5±8.9歲)是否有足部血循病變，以血管攝影作為標準準則，使用敏感度(糖尿病患血管攝影有足部血循病變，並判為有糖尿病合併足部血循病變)、特異度(糖尿病患血管攝影無足部血循病變，並判為有糖尿病無足部血循病變)及Receiver operating characteristic(ROC)曲線分析，探討於早、中、晚三個時段表面溫度診斷之準確性，並制定其DPTR之診斷指標。

表面溫度量測結果顯示：（1）在正常族足背和足底內側所呈現的溫度分別為28.6±2.13度和29.3±2.46度，並測得DPTR為1.02±0.03；（2）糖尿病由血管攝影診斷出無足部血循病變之族群所呈現的溫度分別為29.8±4.03度和30.5±3.36度，並測得DPTR為1.03±0.06；（3）糖尿病由血管攝影診斷出有足部血循病變之族群所呈現的溫度分別為29.1±2.75度和28.1±2.99度，因此並測得DPTR為0.96±0.02；以足背和足底內側最具代表性。以血管攝影結果作為標準，利用統計學方式來完成表面溫度量測於臨床療效之ROC曲線分析，於早上測量之準確性較高，當DPTR小於等於0.997時，為糖尿病足合併血循病變，此時敏感度為96.3%和特異度為94.74%。綜合以上的研究成果，正常族與糖尿病族由於足背血管供應源頭為足背動脈，其週邊無太多的組織包覆，其表面溫度較低；由於體內每一部分組織血流量幾乎都是依據組織的需求大小而受到嚴密的控制，而足底內側的組織需求較高，導致表面溫較高，但於糖尿病有足部血循病變族群中，內蹠動脈最易堵塞且灌流下降，導致該區塊表面溫度較低，因此DPTR具有臨床診斷之意義。

本研究探討足部表面溫度變化於糖尿病足合併血循病變，可提供臨床應用的基礎資料，達到早期診斷及早期治療之目的。目前糖尿病足的成因已知有限，因此針對不同型態病變的診斷極為困難。本研究之初步結果可以提供發展非侵入糖尿病足診斷系統之規格參考。在未來之研究，仍需要進行大量的樣本數來進一步分析，以提供更精確的量測進而發展出全面性的監測系統來有效防止糖尿病足血循病變所帶來的威脅。

Lifestyle changes (e.g. eating habits) and increasing aging population have led to the dramatically increased prevalence of type II diabetes. Diabetes (DM) is a serious complicated illness; acute and/or chronic complications occur along with Hyperglycemia and Glycosylation development. Diabetic foot includes infection, ulceration and destruction of deep tissues associated with neurological abnormalities and various degrees of peripheral vascular disease in the lower limb. Neuropathy and/or Vasculopathy have eventually led to blood flow deficiency which causes tissue necrosis and even requires amputation. Physical examinations of claudication, cold sensation or absence of palpable peripheral pulses are commonly used to early detect the foot circulation problems. However, these methods may not identify diabetic foot patients in the early development stage. Angiography remains the gold standard for identifying peripheral arterial occlusive disease (PAOD) and areas of occlusion in the arterial system, but angiography is invasive, expensive and radiative. The purpose of this research was to develop innovatively a cost-effective/non-invasive/in vivo surface temperature measuring to diagnose circulatory disorder on DM foot. More specifically, this research was aimed to: (1) investigate the skin surface temperature patterns on anterior ankle, dorsum foot, medial plantar foot, later plantar foot, heel and lateral ankle regions; (2) develop a clinical protocol of surface temperature measuring to detect PAOD on diabetic foot; (3) evaluate the accuracy of this temperature test by analyzing sensitivity, specificity and receiver operating characteristic curve.

This research was divided into two stages of experiments. In the first stage, 50 normal subjects and 100 diabetic subjects, which were recruited and signed consented inform of IRB from E-DA Hospital (Taiwan)/China Medical University Hospital (Taiwan), were conducted skin surface temperature measurements by using a high sensitive infrared thermometer on anterior ankle, dorsum foot, medial plantar foot, later plantar foot, heel and lateral ankle regions located by a hand held Doppler sensor probe at morning, afternoon, night session. The surface temperature data were analyzed to derive Dorsal-Plantar Foot Superficial temperature ratio (DPTR) as the criteria of clinical diagnostic protocol for the circulatory disorder on diabetic foot. In the second stage, 81 DM subjects with PAOD and 19 DM subjects without PAOD, which were diagnosed by angiography, were conducted surface temperature measurements on dorsum foot and medial plantar foot regions with corresponding DPTR calculation at morning, afternoon, night session. The accuracy of the test based on DPTR < 1 for PAOD detection was determined by sensitivity, specificity and receiver operating characteristic (ROC) curve.

The results of skin surface temperatures show that (1) the surface temperatures on dorsum foot and medial plantar foot regions of normal group are 28.6±2.13°C and 29.3±2.46°C with corresponding DPTR = 1.02±0.03 at morning session; dorsum foot and medial plantar foot regions are the most representative among these six angiosomes on normal group; (2) the surface temperatures on dorsum foot and medial plantar foot regions of DM group without PAOD are 29.8°C±4.03°C and 30.5°C±3.36°C with corresponding DPTR = 1.03±0.06 at morning session; (3) The surface temperatures on dorsum foot and medial plantar foot regions of DM group with PAOD are 29.1°C±2.75°C and 28.1°C±2.99°C with corresponding DPTR = 0.96±0.02 at morning session. The results of accuracy analysis indicate that at morning session, the sensitivity is 96.3% and the specificity is 94.74% with ROC curve setting DPTR < 0.997 for circulatory disorder detection.

The surface temperature of the dorsal region is lower on normal patients and diabetic patients without PAOD for the reason that dorsalis pedis artery has less soft tissue embedded, which makes energy release rapidly. Tissues of the medial plantar region have higher demand on blood, and its temperature raise accordingly. Medial plantar artery is easy to be blocked on DM patients with PAOD, which causes the decrease in the blood circulation amount and decrease the temperature of dorsal region. Therefore, the diagnosis of DPTR < 1 is likely to be useful for PAOD screening test.

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