Toe-brachial Index Research Articles

Near-instant noninvasive optical imaging of tissue perfusion for vascular assessment

BackgroundNoninvasive vascular tests are critical for identifying patients who may benefit from surgical revascularization, but current tests have significant limitations in people with diabetes. This study aimed to evaluate the ability of spatial frequency domain imaging (SFDI), an optical imaging method capable of measuring tissue oxygen saturation (StO2) and tissue hemoglobin, to assess lower extremity blood supply. MethodsAnkle-brachial index, toe-brachial index, pedal Doppler waveforms, and SFDI images were prospectively evaluated in 47 consecutive patients with and without diabetes in whom there was concern for peripheral artery disease (PAD). SFDI is a noncontact optical imaging technology that uses structured illumination to quantify subsurface (2-3 mm in depth) StO2 and tissue hemoglobin in the dermal microcirculation (HbT1) and macrocirculation (HbT2) over a large field of view (15 × 20 cm) within 10 seconds. ResultsThis demonstrates the ability of SFDI to capture reliable clinical measurements of perfusion in plantar aspects of the feet. SFDI StO2 values differentiate nondiabetic patients with and without arterial disease, defined as ankle-brachial index <0.9 (P = .06), but are limited in those with diabetes (P = .43). An elevated StO2 and reduced HbT1 are observed in people with diabetes compared with nondiabetic patients (P < .05). An SFDI-derived HbT2/HbT1 index differentiates diabetics with PAD vs no PAD (P < .01) using toe-brachial index <0.7 as a cutoff for PAD in diabetes. ConclusionsSFDI is a feasible, rapid, and easy to use widefield measurement of perfusion in a clinical setting. This first-of-use study suggests that the technology has potential to evaluate lower extremity perfusion in people with and without diabetes. Further studies with increased numbers of patients and end points including wound healing will need to be designed to fully evaluate the applicability of this new technology.

Agreement of clinical tests for the diagnosis of peripheral arterial disease

AimThe aim of this study was to compare different screening modalities in the detection of PAD in a primary care setting. MethodsFifty participants living with Type 2 diabetes were recruited. Pulse palpation, waveform analysis, ankle brachial pressure index, absolute toe pressure, toe brachial pressure index and transcutaneous oxygen pressure were compared in the detection of peripheral arterial disease. One hundred limbs were included for analysis. ResultsThis study showed different results in peripheral arterial disease screening tests in the same group of participants. The highest percentage of participants who had PAD was for the Doppler Waveform (93.0%). This was followed by TBPI (72.0%), ABPI (57.0%), ATP (35.0%), TCPO (30.0%) and pulse palpation (23.0%). The difference between these percentages is significant (p<0.0005). The magnitude of the effect size is medium/moderate (Cramer’s V=0.498). ConclusionThis study demonstrates that inconsistencies exist between the agreement of the 6 different modalities used to detect PAD. These findings should create an awareness amongst clinicians when interpreting results of these tests. The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which screening modalities would yield the most valid results.

Carotid intima-media thickness and plagues are associated with indicators of peripheral artery diseases in patients with diabetes

AimsWe investigated associations of carotid intima-media thickness (CIMT) and carotid plaque with ankle-brachial index (ABI) and toe-brachial index (TBI) in Chinese adults. MethodsA cross-sectional analysis was performed in 6688 participants from a well-defined Chinese community. CIMT and carotid plaque was measured with a high-resolution B-mode tomographic ultrasound system. Low ABI was defined as ABI ≤ 0.90. Low TBI was defined as TBI ≤ 0.60. Carotid plaques were classified as normal, homogeneous or heterogeneous according to morphology. ResultsAfter adjusting for age, sex and body mass index, each 0.10 mm CIMT increase was associated with 0.0123 unit decrease in TBI (P = 0.004) and 0.0063 in ABI (P = 0.04) in patients with diabetes. After further adjustments for waist circumference, smoking and drinking habits, hypertension, lipids and hemoglobin A1c, the associations between CIMT and TBI remained significant; while those with ABI were disappeared. Meanwhile, each 0.10 mm increment of CIMT or rank of carotid plaque morphology was associated with a risk of presence of low TBI (CIMT: odds ratio: 1.21, 95% confidence interval: 1.05–1.40; carotid plaque morphology: 1.45, 1.01–2.08) in patients with diabetes after adjustments. However, no associations were found between CIMT or carotid plaque morphology and TBI or ABI in non-diabetic participants. ConclusionsCIMT and carotid plaque morphology were significantly associated with TBI in patients with diabetes.

The correlation between plasma homocysteine level and lower extremity atherosclerotic disease in elderly patients of Chinese Han nationality with primary hypertension

Objective To investigate the correlation between plasma homocysteine(Hcy)level and lower extremity atherosclerotic disease(LEAD)in elderly patients of Chinese Han nationality with primary hypertension. Methods A total of 144 elderly Chinese Han outpatients with primary hypertension aged 60-90 years(92 cases in men, 52 in women)were randomly recruited in our department from January 2015 to January 2017. The diagnosis of LEAD was confirmed in this study by ankle brachial index(ABI)≤0.90(ABI normal value=1.00-1.40). The patients were divided into three different plasma Hcy level groups: low-(<10 μmol/L), middle-(10-29 μmol/L), and high-Hcy level group(≥30 μmol/L). The differences in Hcy, ABI, toe branchial index, high density lipoprotein, apolipoprotein-A1, and baPWV were compared between three different Hcy level groups. Pearson correlation was established between the influencing factors and serum level of Hcy. Moreover, binary logistic regression model was used to determine the independent risk factors for LEAD among elderly Chinese Han patients with primary hypertension. Results The values of apolipoprotein A-1, high density lipoprotein cholesterol, ankle brachial index, and toe brachial index were higher in the low Hcy group than in the middle-and high Hcy-group(P 0.05). Pearson correlation analysis showed that the level of serum Hcy was positively correlated with brachial-ankle pulse wave velocity(r=0.637, P=0.000), while it was negatively correlated with ankle brachial index, toe branchial index, high density lipoprotein cholesterol, and apolipoprotein A-1(r=-0.743, -0.257, -0.240, -0.449, all P<0.05). Binary Logistic regression model showed that gender, Hcy, and low density lipoprotein cholesterol level were independent risk factors for LEAD in elderly Chinese Han patients with primary hypertension. Conclusions Plasma Hcy level is an independent risk factor for LEAD in elderly Chinese Han patients with primary hypertension, and it is positively correlated with this disease. Key words: Cysteine; Atherosclerosis; Hypertension; Lower extremity

The reliability of the ankle-brachial index and toe-brachial index in the daily practice of peripheral artery disease monitoring in vascular medicine ward

The reliability of the ankle-brachial index and toe-brachial index in the daily practice of peripheral artery disease monitoring in vascular medicine ward

Retrospective Analysis of Correlation between Peripheral Artery Disease and Diabetic Retinopathy in Type 2 Diabetes Patients

There are no enough evidences which show the correlation of peripheral arterial disease (PAD) and diabetic retinopathy (DR) in patients with type 2 diabetes mellitus (T2DM). We have tried to explore the relationship between PAD and DR in this study. Method: Patients with T2DM since more than 5 years with HbA1c &amp;gt; 7% and patients with DR or with no DR were included in this cross-sectional study. As a part of our clinical protocol at the first visit all type 2 DM patients are assessed through ABI, VPT, CAN and retinoscope for their complications. A history of addiction including smoking and tobacco were recorded. Stages of DR were graded by digital retinal photographs using Zeiss VISUCAM. PAD assessment was done by using Ankle Brachial Index (ABI), Toe Brachial Index (TBI) and ultrasound doppler. Result: It was found that out of 573 patients attended OPD in month of November 2017 at Dia Care - Diabetes Care and Hormone Clinic were taken into this study. Out of these 573 patients, the HbA1c of 475 patients was uncontrolled (&amp;gt;8%) with duration of diabetes of 7.5 ± 1.2 years.Out of this, 138 patients were having DR [34 Proliferative Diabetic Retinopathy (PDR) and 104 Non-Proliferative Diabetic Retinopathy (NPDR)].It was seen that patients with DR had a significantly higher proportion of Peripheral Arterial Disease (ABI &amp;lt; 1 and &amp;gt; 1.3) compare to patients who did not have DR (53 out of 138 vs. 59 out of 337). The patients with DR also had lower TBI and abnormal duplex ultrasound than patients who did not have DR. This showed the correlation between DR and PAD that in patients with DR the incidence of PAD was more common. We also observed the relation between duration of diabetes and uncontrolled glycemic status with that of PAD and DR. We are still evaluating these patients further to establish a positive relation between these variables. Conclusion: We should focus on screening PAD in patients with DR in clinical practice. Disclosure H. Chandarana: None. B.D. Saboo: None. A. Patel: None. D. Hasnani: None. S. Shah: None. R. Goklani: None. D. Panchal: None. M. Saiyed: None. D.B. Chudasama: None.

Systematic Review of Methods Used for the Microvascular Assessment of Peripheral Arterial Disease.

Lower extremity peripheral arterial disease (LEAD) is increasing in prevalence in low with approximately 202 million people affected with LEAD worldwide. Certain subgroups of individuals (cigarette smokers, diabetics) that are particularly high risk for LEAD and major adverse limb events (MALE). Conventionally, the ankle-brachial index (ABI) is the recommended screening test for LEAD. However, the ABI has several limitations, particularly in patients with diabetes. These limitations include increased measurement variability with severity of LEAD, non-compressible calcified arteries inability to detect arterial disease distal to the ankle precludes assessment of disease in the foot where many ulcers can occur, and underestimation of the extent of microvascular occlusive disease. In this systematic review, we discuss methods used for the assessment of microvascular disease and compare outcomes that encompass microvascular flow with the ABI and toe-brachial index (TBI).

Toe-brachial index is associated more strongly with progression of diabetic nephropathy than ankle-brachial index in type 2 diabetic patients

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Toe brachial index predicts major adverse cardiovascular events in patients with type 2 diabetes

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Clinical examination and non-invasive screening tests in the diagnosis of peripheral artery disease in people with diabetes-related foot ulceration.

Peripheral artery disease is common in people with diabetes-related foot ulceration and is a risk factor for amputation. The best method for the detection or exclusion of peripheral artery disease is unknown. This study investigated the utility of clinical examination and non-invasive bedside tests in screening for peripheral artery disease in diabetes-related foot ulceration. Some 60 people presenting with new-onset ulceration participated. Accuracy of pulses, ankle pressure, toe pressure, toe-brachial index (TBI), ankle-brachial pressure index (ABPI), pole test at ankle, transcutaneous oxygen pressure and distal tibial waveform on ultrasound were examined. The gold standard diagnostic test used was > 50% stenosis in any artery or monophasic flow distal to calcification in any ipsilateral vessel on duplex ultrasound. The negative and positive likelihood ratios of pedal pulse assessment (0.75, 1.38) and the other clinical assessment tools were poor. The negative and positive likelihood ratios of ABPI (0.53, 1.69), transcutaneous oxygen pressure (1.10, 0.81) and ankle pressure (0.67, 2.25) were unsatisfactory. The lowest negative likelihood ratios were for tibial waveform assessment (0.15) and TBI (0.24). The highest positive likelihood ratios were for toe pressure (17.55) and pole test at the ankle (10.29) but the negative likelihood ratios were poor at 0.56 and 0.74. Pulse assessment and ABPI have limited utility in the detection of peripheral artery disease in people with diabetes foot ulceration. TBI and distal tibial waveforms are useful for selecting those needing diagnostic testing.

Panax notoginseng extract combined with alprostadil in treatment of arteriosclerosis obliterans: Meta-analysis

To evaluate the clinical efficacy of Panax notoginseng extract combined with alprostadil in the treatment of arteriosclerosis occlusion and investigate its effects on the degree of atherosclerosis. CNKI, Wanfang, VIP journal database, Chinese biomedical literature database(CBM), PubMed, the Cochrane Library and Science Citation Index(SCI) database were searched between inception to December 2017 for relevant studies. Two researchers independently screened and extracted the literature in strict accordance with the inclusion criteria and exclusion criteria. The bias risk assessment method recommended by Cochrane was used to evaluate the bias risk and extract data, and then Review Manager 5.3 was used for Meta analysis. 10 RCTs involving a total of 1 032 cases were included in the study. Analysis results showed that the P. notoginseng extract combined with alprostadil had higher clinical efficacy than alprostadil alone in the treatment of arteriosclerosis occlusion disorder, with statistically significant difference(OR=6.39, 95%CI[3.97, 10.30], P<0.000 01); the atherosclerosis was obviously improved, including ankle brachial index(ABI) (MD=0.08, 95%CI[0.04, 0.13], P=0.000 3), toe brachial index(TBI) (MD=0.09, 95%CI[0.05, 0.12], P<0.000 01), and maximum walking distance(WD) (MD=471.62, 95%CI[383.54, 559.70], P<0.000 01). Studies have shown that P. notoginseng extract combined with the conventional treatment had significantly improved clinical efficacy in the treatment of arteriosclerosis occlusion, and could improve the atherosclerosis degree of lower extremities. However, the quality of the included literature was not high, in addition, due to the small number of included literature as well as bias and low-quality bias in some of the literature, more high quality RCTs are still needed to further verify the clinical effect of P. notoginseng extract in the treatment of arteriosclerosis occlusion.

148 Difference of Ankle-Brachial and Toebrachial Indices and Its Association with Mortality in Persons Evaluated for Peripheral Artery Disease

148 Difference of Ankle-Brachial and Toebrachial Indices and Its Association with Mortality in Persons Evaluated for Peripheral Artery Disease

Temporal (in)stability of suboptimal toe-brachial indices

ObjectiveTo be effective in screening, prognostic, and monitoring contexts, the toe–brachial index (TBI) should not be susceptible to large sporadic fluctuations from one time to another. In order to identify whether those fluctuations exist in people who have suboptimal TBIs, the temporal stability of their TBIs was examined in detail across 6 months. MethodsTBI readings from SysToe and Omron automated devices were taken from 21 participants at baseline and at 2- and 6-month timepoints subsequently. The primary inclusion criterion was that participants had at least one of three baseline TBIs on either foot ≤0.65 if a standard 25-mm wide occlusion cuff was used, or ≤0.85 if a 15-mm occlusion cuff was used. ResultsAfter excluding five participants because of their extremely high TBI fluctuations, TBI stability within the remaining 16 participants was examined. Ipsilateral TBIs changed by ≥0.10 on at least one foot for 11 participants across the initial 2-month timespan (maximum difference 0.26) and for same number of participants across the full 6-month timespan (maximum difference 0.36), with the composition of the 11-person groups differing slightly for the two timespans. Contralateral differences were ≥0.10 for five participants across the 2-month timespan (maximum difference 0.26) and for nine participants across the 6-month timespan (maximum difference 0.42), again with some group overlap. The foot with the higher TBI at baseline remained so across the 6 months. ConclusionsFor many people with suboptimal TBIs there might be inherent ipsilateral and contralateral inconsistency among TBI readings. This threatens the effectiveness of TBIs for screening, prognostic, and monitoring purposes. In order to maximize the prospects of the TBI as a valuable metric, adherence to standard protocols should be observed and other prospects for the TBI to assess vascular supply to the foot more effectively should be considered.

Noninvasive measurements of tissue perfusion in critical limb ischemia.

Critical limb ischemia (CLI) remains a challenge for an interdisciplinary therapeutic team due to chronic nonhealing wounds. Against this background, there is a necessity of quality control after revascularization. Beside the isolated evaluation of the macrocirculation by Ankle-Brachial or Toe-Brachial Index measurements, the microcirculation as an additional important factor of wound healing often remains underestimated. The following article gives an overview about the current investigation methods for noninvasive perfusion control of the CLI patient. Therefore, transcutaneous oxygen pressure (tcpO2), the “oxygen-to-see” method which is a combination of white light tissue spectrometry and laser-Doppler flowmetry, fluorescence angiography with indocyanine green, and multispectral optoacoustic tomography will be described.

Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites

ObjectiveEthnic minorities (nonwhites) with critical limb ischemia (CLI) have historically performed worse compared with whites with regard to major amputation risk reduction and amputation-free survival (AFS) after peripheral vascular intervention. This post hoc analysis was completed to determine whether this precedent also extended to treatment of CLI without a suitable revascularization option with intramuscular injections of concentrated bone marrow aspirate (cBMA). MethodsThe treatment arm of the randomized, double-blind, multicenter MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial was stratified by ethnicity and evaluated for demographics, comorbidities, and outcomes. The primary and therapeutic end point was 1-year AFS and major amputation, respectively. Noninferiority analysis was performed with the margin set at historically reported hazard ratios. ResultsThirty-seven minority (African American, Hispanic, other) CLI patients (9 placebo, 28 cBMA) with no suitable revascularization option were randomized to cBMA or placebo at a 3:1 ratio during the MOBILE trial. At 1-year follow-up for the treatment group, overall AFS was 80%. Of the 28 minority patients randomized to cBMA intervention, an 89% AFS rate was observed compared with 77% in whites. Specifically, 22 of 24 (92%) African Americans survived amputation free at 1-year follow-up. Noninferiority testing confirmed no difference between whites and the ethnic minority treated with cBMA with respect to major amputation reduction; however, noninferiority could not be confirmed with regard to AFS. No significant differences favoring whites treated with cBMA were noted in the secondary end points of vascular quality of life, limb pain, ankle-brachial index, toe-brachial index, transcutaneous oximetry, and 6-minute walk testing. ConclusionsThis post hoc analysis of the MOBILE trial demonstrates noninferiority of cBMA intervention in minorities with no-option CLI for the therapeutic end point of major amputation prevention. cBMA represents a novel treatment paradigm and should be explored for minorities with poor revascularization options who face impending amputation secondary to progressive CLI.

Anticoagulation Obtained below the Arterial Clamp Using a Single Fixed Bolus of Heparin in Vascular Surgery: A Pilot Study

No clear recommendations exist regarding the optimal dosing of unfractionated heparin (UFH) during vascular surgery. Moreover, little is known about the effect of the UFH bolus downstream of the arterial clamp, where stasis and inflammation can possibly alter the anticoagulation obtained. The aim of our prospective observational study was to assess anticoagulation below the arterial clamp and its clinical impact on the quality of revascularization. Thirty-six patients American Society of Anaesthesiologists physical status (ASA) grade I-III undergoing open revascularization surgeries were included. A baseline activated coagulation time (ACT) was obtained. Thirty minutes after a single bolus of 5,000 units of UFH, we measured an upstream ACT via a radial arterial catheter and an ACT below the arterial clamp via surgeon sampling. The quality of revascularization was assessed with preoperative and postoperative ankle-brachial and toe-brachial indexes (TBIs). The upstream postheparin ACT was significantly higher than the downstream postheparin ACT, with a mean difference of 24.3sec (P<0.0001). In 7 patients, the downstream ACT was lower than the baseline ACT. The upstream and downstream heparin concentrations were similar. There was no relationship between the downstream ACT and either ankle-brachial index improvement (28 patients, P=0.51) or TBI improvement (27 patients, P=0.21). Our study demonstrates a significant difference between the ACT above and below the arterial clamp without any clinical impact of this possibly insufficient anticoagulation. Further investigations are warranted to determine the optimal dose of UFH in vascular surgery. Clinicaltrials.gov, NCT02477072.

Autologous bone marrow-derived mononuclear cell therapy in Chinese patients with critical limb ischemia due to thromboangiitis obliterans: 10-year results

BackgroundFor patients with thromboangiitis obliterans (TAO), revascularization with bypass or angioplasty is frequently not feasible due to the poor outflow of the distal small vessels. We evaluated the long-term results of our experience treating patients with TAO with autologous bone marrow-derived mononuclear cells (ABMMNCs) to determine the safety and efficacy of ABMMNC therapy in patients with critical limb ischemia due to TAO.MethodsThis was a retrospective chart review from a single university hospital vascular surgery center between January 2005 and July 2006. Patients were treated with smoking cessation and either aspirin (100 mg/day) alone or aspirin and ABMMNC injection according to patient preference. Groups were compared for demographics, clinical characteristics, and short-term and long-term results.ResultsOf 59 patients with TAO who were treated, 19 patients elected aspirin alone and 40 patients elected aspirin and ABMMNC injection. No patients suffered perioperative complications and 49 (83%) patients remained smoke-free for 10 years. The 10-year amputation-free survival was 85.3% (29/34) in patients treated with ABMMNCs compared to 40% (6/15) in patients treated with aspirin alone (p = 0.0019). Ulcer area (p < 0.0001), toe-brachial index (TBI; p < 0.0001), transcutaneous oxygen pressure (TcPO2; p < 0.0001), and pain score (p < 0.0001) were also significantly improved with ABMMNC treatment, although there was no difference in mean ankle-brachial index (ABI; p = 0.806).ConclusionsIn patients with critical limb ischemia due to TAO, ABMMNC treatment was safe and effective. ABMMNC treatment significantly improved amputation-free survival, ulcer healing, and pain, although there is no difference in ABI compared to treatment with aspirin alone.

Risk factors for patients with diabetes who have abnormal toe-brachial index and normal ankle-brachial index.

To investigate the association of ankle-brachial index (ABI) and toe-brachial index (TBI) with metabolic parameters and the risk factors causing a divergence between ABI and TBI in patients with diabetes. Outpatients who were simultaneously examined for both ABI and TBI were included. Multiple regression analysis was performed to assess the association of ABI and TBI with metabolic parameters. Furthermore, logistic regression analysis was performed to detect the risk factors causing a divergence between ABI and TBI. Of the 307 patients that were enrolled, 77 had normal ABI but decreased TBI. ABI was inversely associated with plasma glucose and triglycerides and positively associated with high-density lipoprotein cholesterol. In contrast, TBI was inversely associated with the duration of diabetes, plasma glucose and haemoglobin A1c. Logistic regression analysis showed that smoking history and a history of cardiovascular disease were associated with an increased risk of the divergence between ABI and TBI. Our findings suggest that smoking history and a history of cardiovascular disease are important risk factors in patients with diabetes who had normal ABI but decreased TBI. Patients with multiple vascular complications are at a high risk of coexisting peripheral artery disease, even if their ABI is normal.

Correlation Between Toe Brachial Index (TBI) and Leg Angiogram Findings

The potential of falsely elevated ABI readings due to medial thickening in patients with advanced PAD can be mitigated by using TBI in such patients. Objective of our study was to describe a correlation between TBI and leg angiogram findings in patients with established PAD or signs and symptoms of PAD who partook in a 6-minute walk test study named STRIDES.

Rationale and design of the Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial investigating the therapeutic mechanism of mesenchymal stromal cells in the treatment of critical limb ischemia

ObjectiveCurrently, there are no accepted nonsurgical therapies that improve the delivery of blood-derived nutrients to patients with critical limb ischemia. Here, we describe the ongoing phase 1/2 Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial, which will provide crucial evidence of the safety profile of mesenchymal stromal cells (MSCs) and explore their therapeutic mechanisms in the setting of critical limb ischemia requiring below-knee amputation (BKA). MethodsIn the CHAMP and the parallel marrowCHAMP trials (hereafter grouped together as CHAMP), a total of 32 extremities with rest pain or tissue loss requiring BKA will be enrolled to receive intramuscular injections of allogeneic MSCs (CHAMP; n = 16) or autogenous concentrated bone marrow aspirate (marrowCHAMP; n = 16) along the distribution of the BKA myocutaneous flap and proximal tibialis anterior. After treatment, subjects are randomized to BKA at four time points after injection (days 3, 7, 14, and 21). At the time of amputation, skeletal muscle is collected at 2-cm increments from the tibialis injection site and used to determine proangiogenic cytokine description, MSC retention, quantification of proangiogenic hematopoietic progenitor cells, and histologic description. Clinical limb perfusion before and after treatment will be quantified using transcutaneous oximetry, toe-brachial index, ankle-brachial index, and indocyanine angiography. Additional clinical end points include all-cause mortality, need for amputation revision, and gangrene incidence during the 6-month post-treatment follow-up. ResultsEnrollment is under way, with 10 patients treated per protocol thus far. We anticipate full conclusion of follow-up within the next 24 months. ConclusionsCHAMP will be pivotal in characterizing the safety, efficacy, and, most important, therapeutic mechanism of allogeneic MSCs and autogenous concentrated bone marrow aspirate in ischemic skeletal muscle.