Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve.

BACKGROUND: Neuromuscular electrical stimulator (NMES) devices increase blood flow to the lower limb by a process of intermittent muscular contraction initiated by a transdermal stimulus to the common peroneal nerve. However, its effects on localized microvascular blood supply to lower limb wounds are unknown. This study is a single-center open label study measuring the effect of neuromuscular stimulation of the common peroneal nerve on the microvascular blood flow within the wound bed of arterial leg ulcers. METHODS: Eights patients with ischemic lower limb wounds had an NMES (geko™) applied to the common peroneal nerve. Baseline and intervention analysis of blood flow to the wound bed and edge was performed using Laser Speckle Contrast Imaging. Mean flow (flux) and pulse amplitude (pulsatility) were measured. RESULTS: Stimulation of the common peroneal nerve with the NMES resulted in a significantly increased flux and pulsatility in both the wound bed and the wound edge in all 8 patients. CONCLUSIONS: Neuromuscular electrical stimulation immediately increases microcirculatory blood flow to the wound bed and edge in patients with ischemic lower limb wounds. These data may provide mechanistic insight into the clinical efficacy of NMES in healing wounds. www.clinicaltrials.gov NCT03186560.

Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study.

OBJECTIVE: Optimal wound-bed preparation consists of regular debridement to remove devitalised tissues, reduce bacterial load, and to establish an environment that promotes healing. However, lack of diagnostic information at point-of-care limits effectiveness of debridement. METHOD: This observational case series investigated use of point-of-care fluorescence imaging to detect bacteria (loads >104CFU/g) and guide wound bed preparation. Lower extremity hard-to-heal wounds were imaged over a 12-week period for bacterial fluorescence and wound area. RESULTS: A total of 11 wounds were included in the study. Bacterial fluorescence was present in 10 wounds and persisted, on average, for 3.7 weeks over the course of the study. The presence of red or cyan fluorescent signatures from bacteria correlated with an average increase in wound area of 6.5% per week, indicating stalled or delayed wound healing. Fluorescence imaging information assisted in determining the location and extent of wound debridement, and the selection of dressings and/or antimicrobials. Elimination of bacterial fluorescence signature with targeted debridement and other treatments correlated with an average reduction in wound area of 27.7% per week (p<0.05), indicative of a healing trajectory. CONCLUSION: These results demonstrate that use of fluorescence imaging as part of routine wound care enhances assessment and treatment selection, thus facilitating improved wound healing.

Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden.

OBJECTIVE: Clinical evaluation of signs and symptoms (CSS) of infection is imperative to the diagnostic process. However, patients with heavily colonised and infected wounds are often asymptomatic, leading to poor diagnostic accuracy. Point-of-care fluorescence imaging rapidly provides information on the presence and location of bacteria. This clinical trial (#NCT03540004) aimed to evaluate diagnostic accuracy when bacterial fluorescence imaging was used in combination with CSS for identifying wounds with moderate-to-heavy bacterial loads. METHODS: Wounds were assessed by study clinicians using NERDS and STONEES CSS criteria to determine the presence or absence of moderate-to-heavy bacterial loads, after which the clinician prescribed and reported a detailed treatment plan. Only then were fluorescence images of the wound acquired, bacterial fluorescence determined to be present or absent and treatment plan adjusted if necessary. RESULTS: We examined 17 VLUs/2 DFUs. Compared with CSS alone, use of bacterial fluorescence imaging in combination with CSS significantly improved sensitivity (22% versus 72%) and accuracy (26% versus 74%) for identifying wounds with moderate-to-heavy bacterial loads (≥104 CFU/g, p=0.002). Clinicians reported added value of fluorescence images in >90% of study wounds, including identification of wounds incorrectly diagnosed by CSS (47% of study wounds) and treatment plan modifications guided by fluorescence (73% of study wounds). Modifications included image-guided cleaning, treatment selection, debridement and antimicrobial stewardship. CONCLUSION: Findings from this pilot study suggest that when used in combination with CSS, bacterial fluorescence may: (1) improve the diagnostic accuracy of identifying patients with wounds containing moderate-to-heavy bacterial loads and (2) guide more timely and appropriate treatment decisions at the point-of-care.

Hyperspectral imaging of tissue perfusion and oxygenation in wounds: assessing the impact of a micro capillary dressing.

OBJECTIVE: Experimental tests of non-invasive multi- or hyperspectral imaging (HSI) systems reveal the high potential of support for medical diagnostic purposes and scientific biomedical analysis. Until now the use of HSI technologies for medical applications was limited by complex and overly sophisticated systems. We present a new and compact HSI-camera that could be used in normal clinical practice. METHOD: We assessed the use of the HSI system on the hands of 10 healthy volunteers, looking at control parameters, and those following venous occlusion, arterial occlusion and reperfusion, including tissue oxygenation, tissue haemoglobin index, perfusion in 4-6mm depth=near infrared spectroscopy (NIR), and tissue water index. Pseudo colours used ranged from 0% (blue) to 100% (red). We also assessed differences in the wounds of three patients. RESULTS: The results show good potential in all parameters in the healthy volunteers, which had high conformity with validated reference oximetry measurements. In three wounds, different levels of oxygenation were identified in the wound area, although interpretation of these results is complex. In Cases 2 and 3, following the application of a micro capillary dressing, improvements were seen in perfusion and reduction of the tissue water index (TWI). CONCLUSION: The camera system proved to be quick, flexible and yielded data with high spatial and spectral resolution. These data will be used to perform a power analysis for a randomised controlled study.

Diagnostic and Therapeutic Ultrasound on Venous and Arterial Ulcers: A Focused Review.

GENERAL PURPOSE: To provide information about the use of ultrasound for diagnostic and therapeutic treatment of venous and arterial ulcers. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After completing this continuing education activity, you should be able to: ABSTRACT: To review the diagnostic and therapeutic use of ultrasound on venous and arterial ulcers. METHODS: PubMed was searched for peer-reviewed articles using the search terms "ultrasound for venous ulcers" and "ultrasound for arterial ulcers." The search yielded 282 articles on ultrasound for venous ulcers and 455 articles for ultrasound on arterial ulcers. Data from 36 articles were selected and included after abstract review. RESULTS: Ultrasound is an established diagnostic modality for venous and arterial disease and is indicated for wound debridement. Recent evidence continues to support its superiority over standard of care in healing venous ulcers, but findings conflict in terms of the effectiveness of low-frequency ultrasound over high-frequency ultrasound. There are currently no standardized treatment protocols for ultrasound. CONCLUSIONS: Diagnostic ultrasound is used to assess venous and arterial disease and guide appropriate treatment for ulcers. Therapeutic low-frequency ultrasound is used to debride the wound bed, as an adjunctive topical wound treatment with standard of care, and to guide the application of other advanced therapies to chronic wounds. Better trial designs and consistent data are needed to support the effectiveness of ultrasound therapy on venous and arterial ulcers.

Dermoscopic Features of Basal Cell Carcinoma on the Lower Limbs: A Chameleon!

BACKGROUND: Lower limbs represent an uncommon location for basal cell carcinoma (BCC) and only few reports have described dermoscopic features of BCC in this body site. Since BCCs of the lower limbs frequently display nonclassic BCC dermoscopic criteria, they can simulate other benign or malignant lesions. OBJECTIVE: Our aim was to describe the dermoscopic features of BCC located on lower limbs and to define which criteria were more associated with their benign- or malignant-looking appearance. METHODS: We conducted a retrospective study enrolling consecutive patients with histologically confirmed BCCs of the lower limbs. Lesions were classified in 7 categories according to the clinical and dermoscopic global appearance. Clear BCC, squamous cell carcinoma (SCC) or Bowen disease-like, Kaposi disease-like, melanoma-like, and aspecific pattern were considered malignant-looking lesions; however, seborrheic keratosis-like and dermatofibroma-like were considered benign-looking. To define which dermoscopic criteria were independently associated with benign- or malignant-looking appearance, we conducted a multivariate logistic regression analysis. RESULTS: A total of 81 BCCs were enrolled: 18 (22%) were benign-looking lesions (of which 11 were seborrheic keratosis-like and 7 dermatofibroma-like) and 63 (78%) were malignant-looking BCCs (of which 24 were clear-cut BCCs, 23 SCC-like, 2 Kaposi disease-like, 9 melanoma-like, and 5 had aspecific pattern). Multivariate regression analysis showed that erosions/ulceration and vessels were independently associated with malignant-looking appearance. The most represented vessels were glomerular and polymorphic, which are more frequently encountered in SCC, together with ulceration. CONCLUSION: BCC of the lower legs frequently simulates other benign or malignant lesions, with SCC being the main differential diagnosis.

ANALYSIS OF TISSUE OXYGENATION IN CHRONIC LEG ULCERS BY COMBINATION OF A MULTI-SPECTRAL CAMERA AND A HYPER-SPECTRAL PROBE.

Objective evaluation of chronic wounds, such as leg ulcers, by the use of non-invasive techniques is of importance for diagnosis, monitoring treatment response, and probably leads to improved treatment strategies. We performed a feasibility study for the combined use of a multi-spectral camera and a hyper-spectral probe to evaluate chronic leg ulcers with a focus on tissue oxygenation. Sixty patients - 40 females and 20 males were enrolled in the study. The age range was 46 to 85 years for males (mean 65.8 years, median 73.0 years) and 51 to 91 years for females (mean 74.4 years, median 77.0 years). Measurements were performed by hyper-spectral wound (HySkinII) probe and multi-spectral (DeMuk) camera on wounds and surrounding skin. The investigation results demonstrate a high variability of oxygenation within ulcers and the surrounding tissue. The methods allow an investigator to independently assess of tissue oxygenation in superficial and deeper layers. Non-invasive multi- and hyper-spectral imaging techniques offer new opportunities of an objective assessment of chronic wounds.

Spectral Clustering for Unsupervised Segmentation of Lower Extremity Wound Beds Using Optical Images.

Chronic lower extremity wound is a complicated disease condition of localized injury to skin and its tissues which have plagued many elders worldwide. The ulcer assessment and management is expensive and is burden on health establishment. Currently accurate wound evaluation remains a tedious task as it rely on visual inspection. This paper propose a new method for wound-area detection, using images digitally captured by a hand-held, optical camera. The strategy proposed involves spectral approach for clustering, based on the affinity matrix. The spectral clustering (SC) involves construction of similarity matrix of Laplacian based on Ng-Jorden-Weiss algorithm. Starting with a quadratic method, wound photographs were pre-processed for color homogenization. The first-order statistics filter was then applied to extract spurious regions. The filter was selected based on the performance, evaluated on four quality metrics. Then, the spectral method was used on the filtered images for effective segmentation. The segmented regions were post-processed using morphological operators. The performance of spectral segmentation was confirmed by ground-truth pictures labeled by dermatologists. The SC results were additionally compared with the results of k-means and Fuzzy C-Means (FCM) clustering algorithms. The SC approach on a set of 105 images, effectively delineated targeted wound beds yielding a segmentation accuracy of 86.73 %, positive predictive values of 91.80 %, and a sensitivity of 89.54 %. This approach shows the robustness of tool for ulcer perimeter measurement and healing progression. The article elucidates its potential to be incorporated in patient facing medical systems targeting a rapid clinical assistance.

A Repeat Validated Population Questionnaire of a Defined Swedish Population Verifies Reduction in Leg Ulcer Prevalence Over Time.

This study was performed to measure if the introduced interventions in leg ulcer care in a selected Swedish county yield a detectable reduction in leg ulcer prevalence in the population. A validated postal questionnaire sent to 10,000 (9,868) randomly selected 30-89 year olds in the Skaraborg county (255,042 inhabitants). All positive responders were telephone interviewed and verified ulcer patients were clinically examined including assessment of arterial/venous circulation with hand-held Doppler and, where indicated, duplex ultrasound scanning. All results were compared with numbers from 1990 (initial study). The response rate was 82% (8,070/9,868), 200 active ulcers and 290 previous ulcers. The calculated prevalence was 0.75% for 30-89 years and 1.05% for 50-89 years (2.1% in 1990). The leg ulcer prevalence was reduced by 32% (0.52% compared to 0.77% in 1990), and the relative risk was reduced by 50% (95%, CI 0.36-0.69). The study shows a true reduction in leg ulcer prevalence detectable in the population supporting a successful care of leg ulcer patients.

An introduction and guide to effective Doppler assessment.

Accurate and timely diagnosis of leg ulceration is an essential factor in making evidence-based, effective decisions regarding patient management with the aim of swift wound healing and/or referral to the appropriate specialty. Nurses are professionally responsible for ensuring that patients receive the appropriate assessment and evidence-based management. This article examines the most up-to-date guidance on Doppler ultrasound as a key element of this assessment. Approaches to assessment will be explored, with emphasis on the need to include a Doppler ultrasound as one key element of a larger, holistic assessment. An introduction to the ankle-brachial pressure index (ABPI) will be given, followed by a step-by-step guide to standard procedures for carrying out a full Doppler ultrasound. Alternative options for measuring ABPI are also provided.

32-year-old Traumatic Arteriovenous Fistula Presenting With Leg Ulcer and High-output Heart Failure.

Traumatic arteriovenous fistula (AVF) is not a common disorder, and dermatological signs and heart failure caused by AVF are rarely reported. We present the case of a 55-year-old woman who was referred for congestive heart failure symptoms. Echocardiography revealed preserved left ventricular ejection fraction. Due to edema of the right leg with a long-standing leg ulcer and palpable femoral thrill, duplex ultrasonography was performed. It showed an AVF between the right superficial femoral artery (SFA) and the right femoral vein (FV). The patient recalled a 32-year-old gunshot injury that was not medically treated. After the diagnosis of AVF she was referred to a surgeon for an AVF ligation, with subsequent resolution of her symptoms. The differential diagnosis of leg ulcer with leg edema should include the possibility of AVF as a cause.

[List of diagnostic tests and procedures in leg ulcer]. / Osnovni dijagnosticki postupci kod bolesnika s venskim ulkusom.

Many factors contribute to the pathogenesis of leg ulcer. Most patients have venous leg ulcer due to chronic venous insufficiency. Less often, patients have arterial leg ulcer resulting from peripheral arterial occlusive disease, the most common cause of which is arteriosclerosis. Leg ulcer may be of a mixed arteriovenous origin. In diabetic patients, distal symmetric neuropathy and peripheral vascular disease are probably the most important etiologic factors in the development of diabetic leg ulcer. Other causes of chronic leg ulcers are hematologic diseases, autoimmune diseases, genetic defects, infectious diseases, primary skin diseases, cutaneous malignant diseases, use of some medications and therapeutic procedures, and numerous exogenous factors. Diagnosis of leg ulcer is based on medical history, inspection, palpation of skin temperature, palpation of arteries, fascia holes, presence and degree of edema, firm painful cords, and functional testing to assess peripheral occlusive arterial disease or identify superficial and deep venous reflux of the legs. Knowledge of differential diagnosis is essential for ensuring treatment success in patients with leg ulcer. There are many possible etiologic factors of leg ulcers and sometimes, clinical findings are similar. Additional testing should be performed, e.g., serologic testing such as blood count, C-reactive protein, HBA1c, erythrocyte sedimentation rate, differential blood count, total proteins, electrolytes, coagulation parameters, circulating immune complex, cryoglobulins, homocysteins, AT, PAI-1, APC resistance, proteins C and S, paraproteins, ANA, ENA, ANCA, dsDNA, antiphospholipid antibodies, urea, creatinine, blood lipids, vitamins and trace elements. Also, biopsy of the lesion for histopathology, direct immunofluorescence, bacteriology and mycology should be included. Other tests are Raynaud (cold stimulation) test and pathergy test. Device-based diagnostic testing should be performed for future clarification. Ankle brachial pressure index, color duplex sonography, plethysmography, MSCT and MR angiography, digital subtraction angiography, phlebography, angiography, x-ray, and capillaroscopy in lupus erythematosus are indicated. Except for bacteriologic analyses of wound biopsies, there is no test to provide specific information on the wound condition.

Application of StyleGAN Architecture for Generating Venous Leg Ulcer Images.

Leg ulcers caused by impaired venous blood return are the most typical chronic wound form and have a significant negative impact on the lives of people living with these wounds. Thus, it is important to provide early assessment and appropriate treatment of the wounds to promote their healing in the normal trajectory. Gathering quality wound data is an important component of good clinical care, enabling monitoring of healing progress. This data can also be useful to train machine learning algorithms with a view to predicting healing. Unfortunately, a high volume of good-quality data is needed to create datasets of suitable volume from people with wounds. In order to improve the process of gathering venous leg ulcer (VLU) data we propose the generative adversarial network based on StyleGAN architecture to synthesize new images from original samples. We utilized a dataset that was manually collected as part of a longitudinal observational study of VLUs and successfully synthesized new samples. These synthesized samples were validated by two clinicians. In future work, we plan to further process these new samples to train a fully automated neural network for ulcer segmentation.

Pulmonary hypertension in patients with Martorell hypertensive leg ulcer: a case control study.

BACKGROUND: Martorell hypertensive ischemic leg ulcer (Martorell ulcer) is characterized by distinct alterations in the arteriolar wall of subcutaneous vessels, leading to progressive narrowing of the vascular lumen and increase of vascular resistance. These changes are similar to the alterations observed in pulmonary arterioles in patients with chronic pulmonary hypertension (PH). This study was aimed to assess an association between the two disorders. METHODS: In this case-control study, 14 patients with Martorell ulcer were clinically assessed for the presence of pulmonary hypertension using transthoracic Doppler echocardiography. Data from patients were compared to 28 matched hypertensive controls. RESULTS: Systolic pulmonary arterial pressure (sPAP) in patients with Martorell ulcer was significantly higher than in the control group (33.8 ± 16.9 vs 25.3 ± 6.5 mmHg, p = 0.023); the prevalence of pulmonary hypertension was 31% (5/14) in patients and 7% (2/28) in controls (p = 0.031). No differences were seen in left heart size and function between patients and controls. CONCLUSION: This study provides first evidence that subcutaneous arteriolosclerosis, the hallmark of Martorell ulcer, is associated with PH. These findings suggest that patients with Martorell leg ulcer might be at significant risk to develop elevated pulmonary arterial pressure. Patients with leg ulcers who present with dyspnea should be evaluated by echocardiography for the presence of pulmonary hypertension.

Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study.

BACKGROUND: Treatment of critical limb ischemia (CLI) by bypass operation or percutaneous vascular intervention is occasionally difficult. The safety and efficacy of multiple intramuscular adipose tissue-derived mesenchymal stem cells (ATMSC) injections in CLI patients was determined in the study. METHODS AND RESULTS: The study included 15 male CLI patients with ischemic resting pain in 1 limb with/without non-healing ulcers and necrotic foot. ATMSC were isolated from adipose tissue of thromboangiitis obliterans (TAO) patients (B-ATMSC), diabetes patients (D-ATMSC), and healthy donors (control ATMSC). In a colony-forming unit assay, the stromal vascular fraction of TAO and diabetic patients yielded lesser colonies than that of healthy donors. D-ATMSC showed lower proliferation abilitythan B-ATMSC and control ATMSC, but they showed similar angiogenic factor expression with control ATMSC and B-ATMSC. Multiple intramuscular ATMSC injections cause no complications during the follow-up period (mean follow-up time: 6 months). Clinical improvement occurred in 66.7% of patients. Five patients required minor amputation during follow-up, and all amputation sites healed completely. At 6 months, significant improvement was noted on pain rating scales and in claudication walking distance. Digital subtraction angiography before and 6 months after ATMSC implantation showed formation of numerous vascular collateral networks across affected arteries. CONCLUSIONS: Multiple intramuscular ATMSC injections might be a safe alternative to achieve therapeutic angiogenesis in patients with CLI who are refractory to other treatment modalities.

Wound Size Imaging: Ready for Smart Assessment and Monitoring.

Significance: We introduce and evaluate emerging devices and modalities for wound size imaging and also promising image processing tools for smart wound assessment and monitoring. Recent Advances: Some commercial devices are available for optical wound assessment but with limited possibilities compared to the power of multimodal imaging. With new low-cost devices and machine learning, wound assessment has become more robust and accurate. Wound size imaging not only provides area and volume but also the proportion of each tissue on the wound bed. Near-infrared and thermal spectral bands also enhance the classical visual assessment. Critical Issues: The ability to embed advanced imaging technology in portable devices such as smartphones and tablets with tissue analysis software tools will significantly improve wound care. As wound care and measurement are performed by nurses, the equipment needs to remain user-friendly, enable quick measurements, provide advanced monitoring, and be connected to the patient data management system. Future Directions: Combining several image modalities and machine learning, optical wound assessment will be smart enough to enable real wound monitoring, to provide clinicians with relevant indications to adapt the treatments and to improve healing rates and speed. Sharing the wound care histories of a number of patients on databases and through telemedicine practice could induce a better knowledge of the healing process and thus a better efficiency when the recorded clinical experience has been converted into knowledge through deep learning.

Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial.

Objective: High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight i:X can improve identification of wounds with high bacterial burden (>104 colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. Approach: A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). Results: Around 287/350 wounds (82%) had bacterial loads >104 CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>104 CFU/g) by fourfold, and this was consistent across wound types (p < 0.001). Specificity of CSS+FL remained comparably high to CSS (p = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. Innovation: This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. Conclusion: Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.

Critical limb ischemia: does long-term patency matter?

In critical limb ischemia (CLI), an underlying principle of treatment is that it takes more oxygenated blood to heal a wound than to maintain tissue integrity. Urgent restoration of perfusion to the ischemic territory, not long-term patency of the target vessel, is the primary treatment goal. However, in patients with CLI treated by surgical bypass, loss of graft patency is associated with poor outcomes. We decided to address the conventional wisdom that restenosis is not a major concern in CLI as long as tissue healing occurs in patients undergoing endovascular revascularization. We retrospectively reviewed the records of consecutive patients treated for CLI with infra-popliteal percutaneous revascularization from 2007 to 2009. Those with prior ipsilateral percutaneous revascularization for CLI formed the study population. Among 29 CLI patients treated for infra-popliteal revascularization, six patients had a history of prior successful ipsilateral revascularization for CLI. All six patients were free of rest pain and ulcers at the 60-day follow-up. The median time interval between the two percutaneous revascularization procedures was 21 months (quartile ranges: 25th = 4.5 months, 75th = 36 months). Five of the six patients had restenosis of a previous lesion, while the sixth patient had a de novo lesion causing recurrent CLI. In conclusion, we found that one in five patients receiving infra-popliteal angioplasty for CLI has had a similar percutaneous revascularization procedure in the past. Among these patients most cases were for restenosis rather than de novo lesions. Further research is needed to determine whether the incidence of recurrent CLI is due to de novo lesions or restenosis. Close clinical follow-up of these patients and maintaining long-term patency with endovascular techniques will likely reduce CLI recurrence.

Drug eluting stents versus PTA with GP IIb/IIIa blockade below the knee in patients with current ulcers--The BELOW Study.

The study was designed as a feasibility trial to evaluate the use of GP IIb/IIIa blockade in connection with drug eluting stents, bare stents and PTA only. Sixty patients with current ulcers were randomly assigned to receive abciximab plus a sirolimus coated stent (N.=14), abciximab plus a bare stent (N.=16), abciximab plus PTA (N.=14) and PTA alone (N.=19). Angiographic control was performed at two and six months. Recanalization was successful in all cases. Two month restenosis rate was 9%, 45.5%, 67% and 46%. At six month follow-up restenosis rate was 9%, 67%, 75% and 58%, respectively; 14% of all patients had major amputations within six months. Adjunctive administration of abciximab during peripheral arterial intervention below the knee was found to be safe. Sirolimus coated stent administration was followed by a higher patency rate.