Prognostic Performance of the Maximal Systolic Acceleration at the Hallux in Healing of Foot Ulcers: A Retrospective Cohort Study.

BACKGROUND: The accurate prediction of foot ulcer healing remains a major challenge in clinical practice. To date, no reliable bedside tests are available. The primary aim of this study was to determine the prognostic performance of the maximal systolic acceleration (ACCmax) to predict ulcer healing. Secondary objectives comprised the investigation of the prognostic accuracy in patients prone to medial arterial calcification and to assess the potential risk of amputation. METHODS: A single-center retrospective cohort study was conducted. Patients aged ≥18 years who presented with a new-onset ulcer (i.e. Fontaine IV and neuropathic ulcers) on the foot and underwent an ACCmax measurement at the hallux were included. Ulcer healing was defined as an intact skin with epithelialization after 3 or 12 months of follow-up. Prognostic performance was calculated by using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR). RESULTS: In total, 136 patients with 143 wounds were included. Almost half of the patients were diagnosed with diabetes mellitus (47%), and wound infection was present in 42% of cases. After 3 months of follow-up, an NPV of 97.9%, PLR of 3.25, and NLR of 0.19 were found when applying an ACCmax threshold of 0.5 m/s2. When looking at 12 months, these numbers were 85.6%, 2.72, and 0.50, respectively. Subgroup analysis for patients with diabetes mellitus and chronic kidney disease showed comparable results. The risk of amputation increased significantly when a measurement below 1.0 m/s2 was present (odd ratio 5.3, P = 0.010). CONCLUSIONS: ACCmax measurements at the hallux can have additional prognostic value in patients with foot ulcers. An ACCmax below 1.0 m/s2 is associated with nonhealing of an ulcer and a higher risk of amputation, while higher ACCmax values are associated with limb salvage. Therefore, ACCmax could be used for grading ischemia in a wound classification system.

Pressure-Relieving Effect of Different Insole Top Covers in People with Diabetes at High Risk of Foot Ulceration.

Pressure-relieving footwear helps prevent foot ulcers in people with diabetes. The footwear design contributes to this effect and includes the insole top cover. We aimed to assess the offloading effect of materials commonly used as insole top cover. We measured 20 participants with diabetes and peripheral neuropathy for in-shoe peak pressures while walking in their prescribed footwear with the insole covered with eight different materials, tested in randomized order. Top covers were a 3 mm or 6 mm thick open or closed-cell foam or a 6 mm thick combination of open- and closed-cell foams. We re-assessed pressures after one month of using the top cover. Peak pressures were assessed per anatomical foot region and a region of interest (i.e., previous ulceration or high barefoot pressure). Walking comfort was assessed using a 10-point Likert scale. Mean peak pressure at the region of interest varied between 167 (SD:56) and 186 (SD:65) kPa across top covers (p < 0.001) and was significantly higher for the 3 mm thick PPT than for four of the seven 6 mm thick top covers. Across 6 mm thick top covers, only two showed a significant peak pressure difference between them. Over time, peak pressures changed non-significantly from -2.7 to +47.8 kPa across top cover conditions. Comfort ratings were 8.0 to 8.4 across top covers (p = 0.863). The 6 mm thick foams provided more pressure relief than the 3 mm thick foam during walking in high-risk people with diabetes. Between the 6 mm thick foams and over time, only small differences exist. The choice of which 6 mm thick insole top cover to use may be determined more by availability, durability, ease of use, costs, or hygienic properties than by superiority in pressure-relief capacity.

Intravascular Ultrasound-Guided Revascularization of Chronic Juxtarenal Aortoiliac Occlusion.

Chronic juxtarenal aortoiliac occlusion (JRO) represents the most severe form of aortoiliac occlusive disease, classified under Trans-Atlantic Inter-Society Consensus (TASC II) as a TASC II D lesion with surgical treatment as the main recommendation. Although endovascular revascularization of other TASC II D lesions are routinely performed, JRO is often considered a contraindication for endovascular treatment due to the extensive nature, extending from the level of the renal arteries down to the iliac arteries. We hereby illustrate an intravascular ultrasound-guided re-entry based technique to facilitate endovascular reconstruction of a JRO. A 58-year-old man with JRO presented with an infected nonhealing forefoot ulcer. A transradial pigtail catheter was positioned at the level of the occlusion as an imaging catheter and landmark for re-entry. Subintimal wiring was performed through bilateral groin accesses to the level of the pigtail catheter. Intravascular-guided re-entry catheter was used to identify the true lumen guide firing of the needle catheter, allowing passage for a guidewire into the true lumen of the suprarenal aorta. The intimal fenestration was dilated using a 4-mm angioplasty balloon which allowed passage of the contralateral guidewire. Kissing stent grafts were deployed bilaterally, extending from the level of the infrarenal aorta down to the level of the distal external iliac arteries in overlapping fashion. Completion angiography showed brisk flow from the aorta through the stented portion into the femoral arteries. The patient underwent forefoot amputation 2 days later with successful wound healing and limb salvage at 6 months.

Vein Harvest Wound Healing after Bypass Surgery for Critical Limb Ischemia.

BACKGROUND: Lower-limb revascularization surgery, especially when performed using the great saphenous vein, predisposes patients to major surgical trauma on initially ischemic tissue. Vein harvest wounds (VHWs) after infrainguinal revascularization heal slowly. This study's aim was to assess the factors associated with VHW healing after infrainquinal bypass surgery for critical limb ischemia (CLI). METHODS: A retrospective patient record study was conducted. All patients with CLI who underwent infrainguinal bypass surgery with autologous vein graft between January 1, 2015, and December 31, 2017, in the Turku University Hospital, were included. Follow-up data were collected until February 28, 2018. The following data was collected from the patient files; risk factors, ankle-brachial indices (ABIs), systolic toe pressures (STPs), the presence of an ischemic ulcer, VHW dehiscence, and the time when the VHW was completely healed. Procedures with outflow vessels at either popliteal or tibial artery were analyzed separately. Descriptive and univariate statistical analyses were performed. RESULTS: Altogether, 195 patients were operated on for CLI, of whom 133 (68.2%) patients had ischemic ulcers. The mean follow-up time was 535.0 days (range 3.0-1143.0 days). The mean ABI improvement was 0.49 (P = 0.00), and STP improvement, 39.9 mm Hg (P = 0.00). The median time taken when VHW was healed was 48.0 days (95% confidence interval [CI], 39.4-56.6) in patients without ischemic ulcers and 82.0 days (95% CI, 59.7-104.3) in patients with ischemic ulcers, P = 0.03. VHW in patients who underwent popliteal artery bypass (62 days, 95% CI, 12.9-93.0) healed faster than VHW in those who underwent tibial artery bypass (132 days, 95% CI, 48.0-93.0), P = 0.02. Risk factors and the preoperative or postoperative ABIs or STPs had no effect on VHW healing time. CONCLUSIONS: VHW healing was remarkably slower after revascularization surgery in patients with an ischemic foot ulcer than in those without ischemic ulcers.

Competing Risk Analysis of the Impact of Pedal Arch Status and Angiosome-Targeted Revascularization in Chronic Limb-Threatening Ischemia.

BACKGROUND: In the context of chronic limb-threatening ischemia, the prognostic impact of angiosome-targeted revascularization and of the status of the pedal arch are debated. METHODS: This series includes 580 patients who underwent endovascular (n = 407) and surgical revascularization (n = 173) of the infrapopliteal arteries for chronic limb-threatening ischemia associated with foot ulcer or gangrene. The risk of major amputation after infrapopliteal revascularization was assessed by a competing risk approach. A subanalysis was made separately for patients who underwent endovascular or open surgical revascularization. RESULTS: At 2 years, survival was 65.1% and leg salvage was 76.1%. Multivariable competing risk analysis showed that C-reactive protein ≥10 mg/dL, diabetes, rheumatoid arthritis, increased number of affected angiosomes, and the incomplete or total absence of pedal arch compared with complete pedal arch (CPA) were independent predictors of major amputation after infrapopliteal revascularization. Multivariable analysis showed increasing risk estimates of major amputation in patients with incomplete (subdistribution hazard ratio [SHR], 2.131; 95% confidence interval [95% CI], 1.282-3.543) and no visualized pedal arch (SHR, 3.022; 95% CI, 1.553-5.883) compared with CPA. Pedal arch was important even if angiosome-targeted revascularization was achieved: Angiosome-directed revascularization in presence of CPA had a lower risk of major amputation (adjusted SHR, 0.463; 95% CI, 0.240-0.894) compared with angiosome-directed revascularization without CPA. In the subanalysis, among patients who underwent endovascular revascularization, CPA (SHR, 0.509; 95% CI, 0.286-0.905) and angiosome-targeted revascularization (SHR, 0.613; 95% CI, 0.394-0.956) were associated with a lower risk of major amputation. CONCLUSIONS: Competing risk analysis showed that a patent pedal arch had significant impact on leg salvage and that the subset of patients undergoing endovascular procedure may most benefit of an angiosome-targeted revascularization.

Risk factors for plantar foot ulcer recurrence in patients with diabetes - A prospective pilot study.

INTRODUCTION: Diabetic foot ulcer (DFU) is a complication of diabetes mellitus (DM) with established recurrence risk factors evaluating patients from United States or Europe. There are scarce studies in developing countries about these risks. The aim of this study was to evaluate risk factors associated with DFU recurrence in a Brazilian prospective cohort. MATERIALS AND METHODS: A prospective cohort of patients with healed DFU followed from January 2014 to June 2017 in Curitiba, Brazil. Periodic home visits from a specialist nurse in DFU were performed during the period of the study to evaluate recurrence of ulcer. The presence of risk factors in the group of patients that developed an ulcer in the follow-up period was compared with the presence of these factors in the group of patients without recurrence. At enrollment, 35 subjects presented a previous ulcer distal with complete healing to follow-up. RESULTS: From 35 patients, 15 were male (43%) and the mean age was of 65.8 ± 10.9 years (48-85 year). Most patients were married with a low income (

[Treatment of plantar, neuropathic and metatarsal ulcers by minimally invasive metatarsal osteotomy]. / Behandlung von plantaren, neuropathischen und metatarsalen Ulzera mittels distaler minimalinvasiver metatarsaler Osteotomie.

BACKGROUND: The chronic-mechanical plantar ulcer in diabetic-neuropathic foot syndrome is the starting point for severe infections of the foot and amputations. Frequent predilection sites are the metatarsal heads (MTH); in the context of neuropathy increased plantar peak pressure occurs and leads to an ulcer. GOAL: In this paper, we will examine whether minimally invasive pressure-reducing osteotomies, such as distal, minimally invasive metatarsal osteotomy (DMMO), can lead to the healing of metatarsal ulcers. Furthermore, the frequency of postoperative complications will be analyzed. METHOD: In a prospective study, n = 26 consecutive patients with plantar grade IA, IIA, and IIIA ulcers according to Wagner/Armstrong were included in the study under MTH 2, 3, 4 and 5 and with an unsuccessful conservative therapy >6 months. All patients received a DMMO of MT 2, 3, and 4, unless the ulcer was under MTH 5, then isolated DMMO MT 5 was performed. Clinical radiological check-ups took place over a follow-up interval of 26 ± 18 months (8-43 months). RESULTS: In all patients, the plantar ulcera healed after 5 ± 1 week, the recurrence rate was 8% and 3 patients had a transfer ulcer. Complications such as infection, pseudarthrosis or neuroosteoarthropathy did not occur. CONCLUSION: DMMO is an effective method for the treatment of recalcitrant ulcers under the metatarsal heads. The rate of a long-term cure is high; the complication rate is low; in ulcers under MTH 5, the DMMO should possibly be extended to the other metatarsal heads to reduce the risk of a transfer ulcer.

Developing a foot ulcer risk model: what is needed to do this in a real-world primary care setting?

AIM: To determine how routinely collected data can inform a risk model to predict de novo foot ulcer presentation in the primary care setting. METHODS: Data were available on 15 727 individuals without foot ulcers and 1125 individuals with new foot ulcers over a 12-year follow-up in UK primary care. We examined known risk factors and added putative risk factors in our logistic model. RESULTS: People with foot ulcers were 4.2 years older (95% CI 3.1-5.2) than those without, and had higher HbA1c % (mean 7.9 ± 1.9 vs 7.5 ± 1.7) / HbA1c mmol/mol (63 ± 21 vs 59 ± 19) (p<0.0001) concentration [+0.45 (95% CI 0.33-0.56), creatinine level [+6.9 µmol/L (95% CI 4.1-9.8)] and Townsend score [+0.055 (95% CI 0.033-0.077)]. Absence of monofilament sensation was more common in people with foot ulcers (28% vs 21%; P<0.0001), as was absence of foot pulses (6.4% vs 4.8%; P=0.017). There was no difference between people with or without foot ulcers in smoking status, gender, history of stroke or foot deformity, although foot deformity was extremely rare (0.4% in people with foot ulcers, 0.6% in people without foot ulcers). Combining risk factors in a single logistic regression model gave modest predictive power, with an area under the receiver-operating characteristic curve of 0.65 (95% CI 0.62-0.67). The prevalence of ulceration in the bottom decile of risk was 1.8% and in the top decile it was 13.4% (compared with an overall prevalence of 6.5%); thus, the presence of all six risk factors gave a relative risk of 7.4 for development of a foot ulcer over 12 years. CONCLUSION: We have made some progress towards defining a variable set that can be used to create a foot ulcer prediction model. More accurate determination of foot deformity/pedal circulation in primary care may improve the predictive value of such a future risk model, as will identification of additional risk variables.

Prevalence of foot ulcers in dialysis-dependent patients.

Hemodialysis patients are at high risk for foot ulceration. The aim of this prospective study was to describe the prevalence and risk factors for foot ulcers in hemodialysis-dependent patients. From 2012 until 2015, all hemodialysis patients (n = 66) above18 years of age, treated at the Alrijne Hospital (Leiderdorp, the Netherlands), were included. Demographics and medical history were collected and the quality of life was measured. Data were collected on common risk factors for foot ulceration: peripheral arterial disease, peripheral neuropathy with or without foot deformities, diabetes mellitus (DM), hypertension, smoking, previous foot ulcer, edema, pedicure attendance, and orthopedic footwear. Sixty-six hemodialysis patients were evaluated; the prevalence of foot ulcer was 21/66 (31.8%). Risk factors were history of foot ulceration in 27/66 (40.9%), ankle-brachial index (ABI) <0.9, and toe pressure < 80 mmHg in 38/66 (57.6%). The percentage of DM in the group of foot-ulcers was higher 13/21 (61.9%) vs. 20/45 (44.4%) in the non-ulcer group, this was not significant (p = 0.183). No differences were found in ABI, toe pressure, peripheral neuropathy and foot deformity, between the DM and non DM group. The mortality between ulcer vs. no ulcer was significant different: 13/21 (61.9%) vs. 11/45 (24.4%) (p = 0.003). Approximately, one-third of hemodialysis patient have a foot ulcer 21/66 (32%). Arterial insufficiency is associated with an increased risk of foot ulcers. In patients with a foot ulcer, survival is significantly lower than in patients without a foot ulcer; interventions to reduce foot ulceration should be implemented for all hemodialysis patients and include frequent inspection, and prompt treatment. Further research should focus on the prevention of foot ulcers in dialysis-dependent patients.

Lateral Malleolar Defect Coverage Using Abductor Digiti Minimi Muscle Flap.

INTRODUCTION: The lateral malleolar region is a prominent anatomic structure vulnerable to repetitive trauma and ulcer formation. The abductor digiti minimi (ADM) muscle flap offers a promising treatment option for the reconstruction of small- to moderate-sized defects that have exposed bone, joint, or tendons in the lateral malleolar area. METHODS: Between 2013 and 2016, 8 patients with foot ulcers were reconstructed with ADM muscle flap. The muscle component of the flap obliterated the dead space and provided a vascularized muscle over the debrided ankle joint. When it is needed, the flap is covered with a small split-thickness skin graft. RESULTS: In all cases, complete healing was achieved. The muscle flap functioned well as a versatile and shock absorbent coverage without recurrence of the ulcer during a mean follow-up period of around 2 years. CONCLUSIONS: Coverage of a soft tissue defect at the lateral side of the ankle remains a challenge for surgeons because of the limited possibilities for local transposition. Free flaps have frequently been associated with postoperative complications and higher costs. Also, not all patients are suitable candidates for free tissue transfer because of existing comorbidities. Coverage with a split-thickness skin graft will not be possible for wounds with exposed bone or neurovascular structures or in wounds involving the weight bearing surface of the foot. Using ADM muscle offers no donor site morbidity, good soft tissue coverage, and an effective healing process. Also, no limb movement affection and normal daily life are acquired.

Quantitative Analysis of Heel Skin Microcirculation Using Laser Doppler Flowmetry and Tissue Spectrophotometry.

OBJECTIVE: To examine perfusion changes in the heel skin of individuals with and without diabetes mellitus to understand how skin is pathologically affected by diabetes mellitus. METHODS: This case-control study was conducted at an academic hospital in Tuebingen, Germany. A total of 30 subjects were enrolled in the study: 15 with known type 2 diabetes mellitus and 15 without. Each subject was asked to lie in a supine position on a hard lateral transfer mat for 10 minutes. MAIN OUTCOME MEASURES: Heel perfusion was quantitatively assessed directly after relief of pressure and after 3 and 6 minutes after relief of pressure using laser Doppler flowmetry and tissue spectrophotometry. MAIN RESULTS: Directly after relief of pressure, blood flow increased in the superficial skin layers (2 mm below the surface of the skin) in both groups. However, in deep skin layers (8 mm below the surface of the skin), blood flow increased in patients with diabetes mellitus and decreased in healthy patients. Oxygen saturation (SO2) was higher in healthy subjects directly after pressure relief. CONCLUSIONS: The increase in blood flow in superficial skin layers indicates reactive hyperemia after exposure in both groups. The prolonged hyperemia in deep skin layers in patients with diabetes indicates increased tissue vulnerability. Despite the increase in blood flow in deep skin layers, the SO2 and thus supply of tissue in patients with diabetes were reduced.

Successful Fat Grafting in a Patient With Thromboangiitis Obliterans.

Thromboangiitis obliterans, or Buerger disease, is a rare nonatherosclerotic segmental inflammatory vasculitis that generally affects young tobacco smokers. Although no surgical treatment is available, the most effective way to halt the disease's progress is smoking cessation. In this case report, a 29-year-old smoker showed up to emergency department with gangrene of his fifth left toe and extensive plantar ulceration. After investigative angiography, he was diagnosed with Buerger disease. On November 2017, he underwent fifth left toe amputation and hyperbaric therapy. Five months after amputation, the patient was rehospitalized because of surgical wound dehiscence, wide ulceration, and pain. He was treated with lipofilling using the Coleman technique. Two weeks after the fat grafting procedure, the patient suspended pain control medication, and after 2 months, the surgical wound was almost healed. Fat grafting (lipofilling) is mostly used in plastic surgery; it offers regenerative effects, with minimal discomfort for the patient. This case report demonstrates a successful alternative use of lipofilling for this unique condition and opens up new options for use of this technique in other fields.

Nanosphere-mediated co-delivery of VEGF-A and PDGF-B genes for accelerating diabetic foot ulcers healing in rats.

Diabetic ischemic ulcer is an intractable diabetic complication. Angiogenesis is a critical factor for wound healing in patients with diabetic foot wounds. Sustained gene delivery could be notably necessary in modulating gene expression in chronic ulcer healing and might be a promising approach for diabetic foot ulcers. In the present study, Sprague-Dawley rats were used to establish diabetic foot ulcer models by streptozotocin and skin biopsy punch. The plasmids expressing VEGF-A and PDGF-B were prepared and then incorporated with polylactic-co-glycolic acid (PLGA) nanospheres to upregulate genes expression. The aim of this study was to explore whether the engineered VEGF-A and PDGF-B based plasmid-loaded nanospheres could be upregulated in streptozotocin-induced diabetic rats and improve the wound healing. The cultured fibroblasts could be effectively transfected by means of nanosphere/plasmid in vitro. In vivo, the expression of VEGF-A and PDGF-B was significantly upregulated at full-thickness foot dorsal skin wounds and the area of ulceration was progressively and significantly reduced following treatment with nanosphere/plasmid. These results indicated that combined gene transfer of VEGF-A and PDGF-B could improve reparative processes in the wounded skin of diabetic rats and nanosphere may be a potential non-viral vector for gene therapy of the diabetic foot ulcer.

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease.

OBJECTIVE: Pedal (inframalleolar) bypass is a long-standing therapy for tibial arterial disease in patients with ischemic tissue loss. Endovascular tibial intervention is an appealing alternative with lower risks of perioperative mortality or complications. Our objective was to compare the effectiveness of these two treatment modalities with respect to patency and limb-related clinical outcomes. METHODS: We performed a retrospective chart review of patients presenting between 2006 and 2013 with ischemic foot wounds and infrapopliteal arterial disease who underwent a revascularization procedure (either open surgical bypass to an inframalleolar target or endovascular tibial intervention). Data were collected on baseline demographics and comorbidities, procedural details, and postprocedure outcomes. The primary outcome was successful healing of the index wound, with mortality, major amputation, and patency assessed as secondary outcomes. RESULTS: We identified 417 patients who met our eligibility criteria; 105 underwent surgical bypass and 312 underwent endovascular intervention, with mean follow-up of 25.0 and 20.2 months, respectively (P = .08). The endovascular patients were older at baseline (P = .009), with higher rates of hyperlipidemia (P = .02), prior cerebrovascular accidents (P = .04), and smoking history (P = .04). Within 30 days postoperatively, there was no difference in mortality (P = .31), but bypass patients had longer hospital length of stay (P < .0001), higher rate of discharge to nursing facility (P < .001), and higher rates of myocardial infarctions (P = .03) and wound complications (P < .001). At 6 months, the rate of wound healing was 22.4% in the bypass group compared with 29.0% in the endovascular group (P = .02). At 1 year, survival was higher after bypass (86.2% vs 70.4%; P < .0001), but freedom from major amputation was similar (84.9% vs 82.8%; P = .42). Primary patency (53.1% vs 38.2%; P = .002) and primary assisted patency (76.6% vs 51.7%; P < .0001) were higher in the bypass group, but there was no difference in secondary patency (77.3% vs 73.8%; P = .13). CONCLUSIONS: Endovascular tibial intervention is associated with poorer primary patency but similar secondary patency and wound healing rates compared with the "gold standard" of surgical bypass to a pedal target. In patients with tibial arterial disease, endovascular intervention should be considered a lower risk alternative to pedal bypass that provides similar clinical outcomes.

Monitoring of pH and temperature of neuropathic diabetic and nondiabetic foot ulcers for 12 weeks: An observational study.

Wound bed assessment is largely reliant on subjective interpretation without recourse to objective tools or biomarkers. The identification of a point of care, reliable biomarker would enhance assessment and ultimately clinical decision making. Two potentially emerging wound biomarkers exist: surface pH and surface temperature. To date, knowledge of their use has been predominantly in wound prevention, in vitro studies and single time measurements. Our objective was to determine surface pH, size, and surface temperature in noninfected, neuropathic foot ulcers at baseline and at 12 weeks. 50 patients (68% [n = 34] had diabetes) participated. Mean baseline pH of wounds was 6.95 (SD 1.01); temperature 30.91 °C (SD 3.00); and size 0.82 cm2 (SD 0.61). After 12 weeks, 26% (n = 13) were lost to follow-up, 50% (n = 25) had healed. Of the remaining patients, mean pH was 6.72 (SD 0.54); temperature 30.88 °C (SD 2.97), and size 0.13 cm2 (SD 0.13). We have provided baseline values for pH and temperature of noninfected, neuropathic diabetic, and nondiabetic foot ulceration. Further studies in a larger cohort are warranted to determine if temperature and or pH are indicative of a healing or nonhealing state.

Indocyanine Green Angiography to Prognosticate Healing of Foot Ulcer in Critical Limb Ischemia: A Novel Technique.

BACKGROUND: To predict wound healing in patients with critical limb ischemia (CLI) is an ongoing issue. Current methods such as ankle-brachial index (ABI), color Doppler and transcutaneous oxygen pressure (TCPO2), and computed tomography angiography are lacking in demonstrating regional perfusion. Indocyanine green angiography (ICGA) has the potential to provide regional perfusion information lacking in other methods. This study was conducted to demonstrate successes of revascularization procedure in CLI patients based on ICGA data. METHODS: A total of 47 patients with grade 2 or grade 3 University of Texas Wound Classification System ischemic foot ulcer undergoing lower limb revascularization procedure were included in this study, from July 2014 to May 2016. ICGA with intravenous 0.1 mg/kg of 0.1% indocyanine green dye was performed before and after revascularization procedure. ICGA data maximum unit, blush time, and blush rate were compared between prerevascularization and postrevascularization data, along with ABI and TCPO2. RESULTS: Out of 47 patients (45 males and 2 females), 43 underwent endovascular revascularization and 4 underwent open procedure. Of all, 76.6% of patients were diabetic and 46.8% were hypertensive. Also, 31.9% had coronary artery disease, 21.2% had history of cerebrovascular disease, 23% had chronic kidney disease, and 74.4% were chronic smokers. A total of 37 patients' ulcer healed completely on follow-up with significant improvement (P < 0.05) in preoperative and postoperative ABI, TCPO2, and ICGA data. Ten patients' ulcer did not heal in the follow-up period. In those 10 patients, preoperative and postoperative ABI and TCPO2 improved, but ICGA data were not improved postoperatively (P > 0.05). CONCLUSIONS: ICGA is an evolving tool to quantify regional perfusion in CLI. ICGA parameters provide qualitative real-time visual images of perfusion in area of interest as well as quantitative information of perfusion.

Peripheral Blood Mononuclear Cells Therapy for Treatment of Lower Limb Ischemia in Diabetic Patients: A Single-Center Experience.

BACKGROUND: The aim of this study is to analyze the effects of peripheral blood mononuclear cells (PBMNCs) therapy in diabetic patients with critical limb ischemia (CLI), with particular regard to its application, as adjuvant therapy in patients underwent endovascular revascularization. METHODS: Fifty diabetic patients affected by CLI were enrolled. All patients underwent PBMNCs therapy. Thirty-two patients underwent PBMNCs therapy associated with endovascular revascularization (adjuvant therapy group). In 18 patients, who were considered nonrevascularizable or underwent unsuccessful revascularization, regenerative therapy with PBMNCs was performed as the therapeutic choice (PBMNCs therapy group). RESULTS: The median follow-up period was 10 months. The baseline and end point results in adjuvant group were as follows. The mean transcutaneous partial pressure of oxygen (TcPO2) improved from 25 ± 9.2 mmHg to 45.6 ± 19.1 mmHg (P < 0.001), and visual analogue scale (VAS) score means decreased from 8.6 ± 2.1 to 3.8 ± 3.5 (P = 0.001). In PBMNCs therapy group, the mean TcPO2 improved from 16.2 ± 7.2 mmHg to 23.5 ± 8.4 mmHg (P < 0.001), and VAS score means decreased from 9 ± 1.1 to 4.1 ± 3.3 (P = 0.001). Major amputation was observed in 3 cases (9.4%), both in adjuvant therapy group and in PBMNCs therapy one (16.7%) (P = 0.6). CONCLUSIONS: The role of cellular therapy with PBMNCs is decisive in the patients that are not susceptible to revascularization. In diabetic patients with CLI and healing resistant ulcers, the adjuvant PBMNCs therapy could represent a valid therapeutic option.

Evaluation of skin perfusion pressure to assess refractory foot ulcers.

OBJECTIVE: The number of patients with foot gangrene caused by critical ischaemia and severe infection is increasing significantly in developed countries. The measurement of perilesional skin blood flow by skin perfusion pressure (SPP) is useful to select the appropriate treatment of gangrenous lesions, in that it is not affected by calcifications of blood vessels. However, the prognosis of a foot ulcer may also be affected by the level of blood sugar and infections. This study aimed to validate the use of SPP in cases of foot gangrene and ulcers in patients with and without diabetes mellitus (DM) and infection. METHOD: Clinical symptoms, ankle-brachial pressure index (ABPI) and SPP were assessed to evaluate the condition of each foot ulcer. Every foot ulcer was treated as independent, even if a participant had multiple ulcers. All ulcers for which we measured SPP were subject to the analysis. All ulcers were purely ischaemic in nature and were exclusively located on the foot or toes. RESULTS: Data were collected from 117 foot ulcers on 91 toes and feet from 65 patients. Almost all SPP values in healed cases were > 27 mmHg. There were three patients whose ulcers failed to heal by conservative treatments were complicated with severe infection. However, no effect of DM on the relationship between SPP values and prognosis was observed. Logistic regression analysis of all ulcers except for the 5 cases complicated with infection revealed that those with 30 mmHg or lower SPP values are likely to heal by conservative treatment with 23% or lower probability, whereas any ulcer with more than 50 mmHg SPP value and without severe infection may heal without the need for further operations with 80% or higher probability. CONCLUSION: The combination of SPP and careful evaluation of infection may be a good parameter to decide the appropriate treatment for ischaemic skin ulcers, regardless of the complication of DM.

Cross-sectional correlations between the toe brachial index and lower limb complications in older people.

The aim of the study was to investigate the relationship between the toe brachial index (TBI) and foot ulceration and amputation in older people. Two hundred and sixty-one participants meeting guidelines for lower limb vascular assessment had their toe and brachial blood pressure measured, medical records audited and signs and symptoms of peripheral arterial disease (PAD) recorded. Pearson's correlation and linear regression analyses were performed to determine the strength of relationships between variables. Significant correlations were found between the TBI and painful symptoms (r = -0·35, P < 0·05) and foot complications (r = -0·31, P < 0·05). After adjusting for traditional risk factors for foot complications, participants with a TBI <0·70 were 19 times more likely to have a history of foot wounds or amputation (odds ratio = 19·20, 95% confidence interval (CI): 2·36-155·96, P < 0·001) than those with higher TBI values (>0·70). This preliminary study supports a TBI threshold of 0·70 for PAD diagnosis and indicates that lower values are associated with painful symptoms, history of ulceration and amputation. Future longitudinal investigation of the predictive capacity is now warranted.

Plantar pressures are higher in cases with diabetic foot ulcers compared to controls despite a longer stance phase duration.

BACKGROUND: Current international guidelines advocate achieving at least a 30 % reduction in maximum plantar pressure to reduce the risk of foot ulcers in people with diabetes. However, whether plantar pressures differ in cases with foot ulcers to controls without ulcers is not clear. The aim of this study was to assess if plantar pressures were higher in patients with active plantar diabetic foot ulcers (cases) compared to patients with diabetes without a foot ulcer history (diabetes controls) and people without diabetes or a foot ulcer history (healthy controls). METHODS: Twenty-one cases with diabetic foot ulcers, 69 diabetes controls and 56 healthy controls were recruited for this case-control study. Plantar pressures at ten sites on both feet and stance phase duration were measured using a pre-established protocol. Primary outcomes were mean peak plantar pressure, pressure-time integral and stance phase duration. Non-parametric analyses were used with Holm's correction to correct for multiple testing. Binary logistic regression models were used to adjust outcomes for age, sex and body mass index. Median differences with 95 % confidence intervals and Cohen's d values (standardised mean difference) were reported for all significant outcomes. RESULTS: The majority of ulcers were located on the plantar surface of the hallux and toes. When adjusted for age, sex and body mass index, the mean peak plantar pressure and pressure-time integral of toes and the mid-foot were significantly higher in cases compared to diabetes and healthy controls (p < 0.05). The stance phase duration was also significantly higher in cases compared to both control groups (p < 0.05). The main limitations of the study were the small number of cases studied and the inability to adjust analyses for multiple factors. CONCLUSIONS: This study shows that plantar pressures are higher in cases with active diabetic foot ulcers despite having a longer stance phase duration which would be expected to lower plantar pressure. Whether plantar pressure changes can predict ulcer healing should be the focus of future research. These results highlight the importance of offloading feet during active ulceration in addition to before ulceration.