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Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to...
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Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition)

A special issue of Biomedicines (ISSN 2227-9059). This special issue belongs to the section "Molecular and Translational Medicine".

Deadline for manuscript submissions: closed (28 February 2025) | Viewed by 9968

Special Issue Editors

Prof. Dr. Irene Hinterseher

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Guest Editor
Berlin Institute of Health, Vascular Surgery Clinic, Charité—Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Hindenburgdamm 30, 12203 Berlin, Germany
Interests: revascularization; vascular; endothelial; growth factor; arterial disease
Special Issues, Collections and Topics in MDPI journals
Dr. Racha El Hage

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Guest Editor
Department of Vascular Surgery, Universitätsklinikum Ruppin-Brandenburg, Fehrbelliner Str. 38, 16816 Neuruppin, Germany
Interests: arterial disease; microbiome; diabetes and endocrinology; gastroenterology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Peripheral artery diseases (PAD) and diabetic foot ulcers (DFU) are life-threatening diseases in the Western world, with crucial importance to the medical field, as they have a major impact on the patient’s quality of life and lead to significant costs for the healthcare system. DFU represent a chronic complication in patients with diabetes; they are often associated with neuropathy and/or peripheral artery disease (PAD) of the lower limb in diabetic patients. PAD is a result of atherosclerosis. The major complication of DFU and PAD is lower limb amputation. Diagnosing PAD is a challenge, as it is asymptomatic in most patients in the early stages and it presents in various ways. Conventional treatments for DFU, including debridement, revascularization, management of infection, and off-loading, have not been shown to be effective enough, and they were not able to reduce the amputation rate. As a result, alternative or additional treatment and new therapeutical approaches in regenerative medicine are required. Furthermore, extra clinical data concerning the risk factors of PAD and DFU, as well as their impact on patients' lives and the healthcare system, are still needed. Molecular inflammatory processes initiating the progress of PAD in diabetics and non-diabetics are still unclear and need to be investigated to create new therapeutical approaches.

Prof. Dr. Irene Hinterseher
Dr. Racha El Hage
Guest Editors

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Keywords

  • peripheral artery diseases
  • diabetic foot ulcer
  • atherosclerosis
  • regenerative medicine
  • inflammatory

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Published Papers (7 papers)

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15 pages, 2354 KiB  
Article
Segmental Pulse Volume Recordings at the Forefoot Level as a Valuable Diagnostic Tool for Detection of Peripheral Arterial Disease in the Diabetic Foot Syndrome
by Andreas Nützel, Lilly Juliane Undine Reik, Maximilian Hamberger, Christian Lottspeich, Sinan Deniz, Anja Löw, Holger Schneider, Hans Polzer, Sebastian Baumbach and Michael Czihal
Biomedicines 2025, 13(6), 1281; https://doi.org/10.3390/biomedicines13061281 - 23 May 2025
Abstract
Introduction: Evidence for the diagnostic yield of noninvasive diagnostic assessment for the diagnosis of peripheral arterial disease (PAD) in diabetic foot syndrome (DFS) is poor. Pulse volume recordings (PVRs) at the forefoot level could be a valuable diagnostic tool in the presence of [...] Read more.
Introduction: Evidence for the diagnostic yield of noninvasive diagnostic assessment for the diagnosis of peripheral arterial disease (PAD) in diabetic foot syndrome (DFS) is poor. Pulse volume recordings (PVRs) at the forefoot level could be a valuable diagnostic tool in the presence of medial arterial calcification. Patients and methods: Patients with DFS who underwent invasive angiography between 01/2020 and 11/2024 and had corresponding PVRs performed within 30 days prior to the procedure were included. DFS was classified according to the Wagner–Armstrong classification. Clinical characteristics and hemodynamic parameters, including systolic ankle pressures and ankle–brachial index were recorded. PVRs were analyzed semiquantitatively by investigators blinded to the clinical information and quantitatively with determination of upstroke time (UST), upstroke ratio (USR), and maximum systolic amplitude (MSA). Angiographic PAD severity was graded according to the GLASS classification. Statistical analysis included univariate significance tests, 2 × 2 contingency tables, receiver–operator characteristic (ROC) analysis and determination of interobserver agreement. Results: In this study, 90 extremities of 70 patients were analyzed, 47 of whom had an ABI ≥ 1.3. Critical limb-threatening ischemia with non-pulsatile PVRs was evident in 6.7%. An abnormal PVR curve morphology (mildly or severely abnormal) yielded a sensitivity and specificity of 63.3% and 85.7% for detection of severe PAD (GLASS stages 2 and 3). Interobserver agreement of semiquantitative PVR rating was substantial (Cohen’s kappa 0.8) in 51 evaluated cases. For detection of any PAD (GLASS ≥ 1) or severe PAD (GLASS ≥ 2), we found the highest diagnostic accuracy for MSA (area under the curve [AUC] 0.89 and 0.82). With a cut-off value of 0.58 mmHg, MSA had a sensitivity of 91.4% and a specificity of 80.8% for detection of any PAD (GLASS ≥ 1). MSA with a cut-off of 0.27 mmHg had a sensitivity of 72.2% and a specificity of 77.1% for detection of severe PAD, whereas the sensitivity and specificity for detection of inframalleolar disease were 62.9% and 69.4%, respectively. Results were consistent in subgroup analyses. Conclusions: PVRs with extraction of quantitative features offer promising diagnostic yield for detection of PAD in the setting of DFS. MSA outperformed UST and USR but showed limited capability of detecting impaired inframalleolar outflow. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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10 pages, 526 KiB  
Article
Neutrophil-to-Lymphocyte Ratio as Potential Marker of Outcome in Popliteal Artery Aneurysm Repair
by Pasqualino Sirignano, Elisa Romano, Giulia Colonna, Flavia Del Porto, Costanza Margheritini, Chiara Pranteda, Nazzareno Stella, Maurizio Taurino and Luigi Rizzo
Biomedicines 2025, 13(3), 651; https://doi.org/10.3390/biomedicines13030651 - 6 Mar 2025
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Abstract
Objective: The neutrophil–lymphocyte ratio (NLR) is an inexpensive and easily available inflammatory marker for cardiovascular disease. The aim of the present study is to evaluate a possible association between preoperative NLR value and popliteal artery aneurysm (PAA) repair outcomes. Methods: A single-center retrospective [...] Read more.
Objective: The neutrophil–lymphocyte ratio (NLR) is an inexpensive and easily available inflammatory marker for cardiovascular disease. The aim of the present study is to evaluate a possible association between preoperative NLR value and popliteal artery aneurysm (PAA) repair outcomes. Methods: A single-center retrospective study on all patients, who underwent urgent or elective PAA repair from June 2010 to October 2022, was performed. Study outcomes were immediate technical success, 30-day and mid-term primary patency, reintervention, limb salvage, and mortality rates. The NLR was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count, and, according to the literature, a cut-off of five has been considered as a possible threshold for the analysis. Results: Eighty-two patients (80 male) with a total of 97 popliteal artery aneurysms were enrolled in this study. The mean preoperative NLR was 2.9 ± 2.4. In 10 (10.3%) PAAs, the NRL was >5 (High-NLR group), and, in the remaining 87 (89.7%), the NLR was <5 (Low-NLR group). The preoperative NLR for urgent procedures was higher than elective cases (4.37 vs. 2.30; p < 0.001). However, no significant differences were found as far as immediate 24 h technical success (p = 0.48) and 30-day primary patency (p = 39). At mean follow-up, the primary patency rate was significantly higher in the Low-NLR group (p = 0.0044), without statistical differences for re-operation (p = 0.27), limb salvage (p = 0.09), and mortality rates (p = 0.51). The Kaplan–Mayer analysis showed a significant difference in freedom from major amputation in patients with an NLR > 5 compared to the ones with an NLR < 5 (p = 0.038), without any differences in terms of survival, primary patency, and the need for reintervention rates. The multivariable Cox regression analysis identified the NLR value as an independent predictor of better outcomes regarding freedom from the amputation rate (p = 0.25). Conclusions: Our experience indicates that a preoperative NLR value > 5 can identify high-risk patients affected by a PAA and may negatively influence the surgery’s long-term outcomes. Therefore, this selected group of patients could need a more tailored approach and closer monitoring over time. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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11 pages, 250 KiB  
Article
Predictive Factors of Amputation in Diabetic Foot
by Francesco Farine, Antonio Maria Rapisarda, Carolina Roani, Cristina Giuli, Chiara Comisi, Antonio Mascio, Tommaso Greco, Giulio Maccauro and Carlo Perisano
Biomedicines 2024, 12(12), 2775; https://doi.org/10.3390/biomedicines12122775 - 6 Dec 2024
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Abstract
Background: Diabetic foot ulcers are a common complication of diabetes mellitus, often leading to progressive sensory deficits, impaired vascularization, and a predisposition to ulceration and gangrene. Untreated ulcers may cause recurrent infections that endanger a patient’s life. Amputation of part of the [...] Read more.
Background: Diabetic foot ulcers are a common complication of diabetes mellitus, often leading to progressive sensory deficits, impaired vascularization, and a predisposition to ulceration and gangrene. Untreated ulcers may cause recurrent infections that endanger a patient’s life. Amputation of part of the limb up to a well-vascularized level is one of the treatments employed for untreated ulcers. Objectives: Laboratory data were analyzed with the aim of identifying risk factors related to surgical amputation treatment of diabetic foot. We believe it is useful to identify risk factors that can be altered from a reversible condition in the clinical decision-making of treatment, thus manifesting themselves in a timely manner to provide the patient with an alternative to surgical amputation of the lower limb. Methods: Our retrospective study was conducted by the Department of Orthopedics and Traumatology at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome. We recruited 200 patients who underwent lower limb amputation for diabetic foot between 2017 and 2021 and had blood tests both 30 days and within 5 days before the first surgery. Results: This case–control study revealed a significant negative correlation between hemoglobin (Hb) levels and the occurrence of leg amputations. In contrast, C-reactive protein (CRP) levels, the neutrophil-to-lymphocyte ratio (NLR), and the platelet-to-lymphocyte ratio (PLR) showed significant positive correlations with leg amputations. A 3-year follow-up of the cases also revealed a significative positive correlation between age, white blood cells (WBC) count, NLR, PLR, and death at 3 years. Conclusions: Our findings suggested that lower Hb levels and elevated CRP, NLR, and PLR levels in patients with diabetic foot disease may be associated with a higher risk of lower-limb amputation. Unexpectedly, this study also demonstrated that elderly age, WBC, CRP, NLR and PLR levels may be associated with a negative prognosis for these patients. These findings highlighted the importance of monitoring these laboratory values in diabetic patients to identify individuals at higher risk of leg amputations and implement appropriate interventions to prevent or minimize the occurrence of this severe complication. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
14 pages, 1699 KiB  
Article
Para-Anastomotic Pseudoaneurysms as a Long-Term Complication After Surgical Treatment of Peripheral Artery Disease: Clinical Characteristics and Surgical Treatment
by Julia Łacna, Michał Serafin, Dorota Łyko-Morawska, Julia Szostek, Dariusz Stańczyk, Iga Kania, Magdalena Mąka and Waclaw Kuczmik
Biomedicines 2024, 12(12), 2727; https://doi.org/10.3390/biomedicines12122727 - 28 Nov 2024
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Abstract
Background: Peripheral arterial disease (PAD) is becoming an increasingly prevalent clinical issue, leading to a growing number of patients requiring surgical interventions. Consequently, there is an increasing occurrence of para-anastomotic aneurysms as late complications following primary treatment for PAD. These aneurysms typically arise [...] Read more.
Background: Peripheral arterial disease (PAD) is becoming an increasingly prevalent clinical issue, leading to a growing number of patients requiring surgical interventions. Consequently, there is an increasing occurrence of para-anastomotic aneurysms as late complications following primary treatment for PAD. These aneurysms typically arise at the sites of graft implantation and necessitate individualized management strategies based on factors such as location, size, and the patient’s overall condition. Materials and Methods: This five-year retrospective study, conducted at a single center, aimed to evaluate the anatomical location, clinical presentation, diagnostic methods, and management strategies for 55 patients treated for femoral and popliteal artery para-anastomotic pseudoaneurysms of the lower limb between January 2018 and June 2024. Treatment approaches were determined based on aneurysm size, the extent of atherosclerosis, and the patient’s surgical risk. This study analyzed patient demographics, surgical techniques, postoperative complications, and aneurysm characteristics. Results: Most pseudoaneurysms occurred between 6 and 10 years after the primary procedure. The most common surgical intervention was aneurysmectomy with graft interposition, performed in 46 patients (83.64%), followed by aneurysmectomy with extra-anatomical bypass in 6 patients (10.91%), and endovascular repair (EVAR) in 3 patients (5.45%). Early postoperative complications occurred in 16.36% of patients. The 12-month freedom from graft stenosis was 87.23%, and freedom from anastomotic aneurysm recurrence at 12 months was 100%. Conclusions: This study highlights the critical need for individualized treatment strategies and ongoing surveillance in managing lower-limb para-anastomotic pseudoaneurysms, particularly given the prevalence of lower-limb pain and the high occurrence of such in the common femoral artery. The favorable long-term graft patency rates observed suggest that aneurysmectomy with graft interposition is an effective intervention, reinforcing its role as the primary approach within this patient population. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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16 pages, 726 KiB  
Article
Three-Year Safety and Efficacy of Endovascular Treatment of Common Femoral Artery in 150 PAD Patients
by Patricia Wischmann, Manuel Stern, David-Ioan Florea, Luise Neudorf, Yassine Haddad, Nicolas Kramser, Miriam Schillings, Sven Baasen, Johanna Schremmer, Christian Heiss, Malte Kelm and Lucas Busch
Biomedicines 2024, 12(10), 2213; https://doi.org/10.3390/biomedicines12102213 - 27 Sep 2024
Viewed by 1211
Abstract
Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients’ frequent co-morbidities. Aims: We aimed to evaluate [...] Read more.
Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients’ frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained “all-comers” Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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14 pages, 2972 KiB  
Article
Impact of Peripheral Angioplasty on Wound Oxygenation and Healing in Patients with Chronic Limb-Threatening Ischemia Measured by Near-Infrared Spectroscopy
by Johanna Schremmer, Manuel Stern, Sven Baasen, Patricia Wischmann, Ramy Foerster, Miriam Schillings, Kálmán Bódis, Roberto Sansone, Christian Heiss, Malte Kelm and Lucas Busch
Biomedicines 2024, 12(8), 1805; https://doi.org/10.3390/biomedicines12081805 - 8 Aug 2024
Viewed by 1850
Abstract
Managing chronic limb-threatening ischemia (CLTI) is challenging due to difficulties in assessing tissue oxygen saturation in ulcers. Near-infrared spectroscopy (NIRS) is a non-invasive method for measuring tissue oxygen saturation (StO2). This study evaluated the effects of endovascular treatment (EVT) on StO [...] Read more.
Managing chronic limb-threatening ischemia (CLTI) is challenging due to difficulties in assessing tissue oxygen saturation in ulcers. Near-infrared spectroscopy (NIRS) is a non-invasive method for measuring tissue oxygen saturation (StO2). This study evaluated the effects of endovascular treatment (EVT) on StO2 and wound healing in CLTI patients, comparing NIRS to standard ankle–brachial index (ABI) measurements. Using the Duesseldorf PTA Registry, 43 CLTI patients were analyzed: 27 underwent EVT, and 16 received conservative treatment. ABI assessed macrocirculation, while NIRS measured wound, wound area, and mean foot StO2 at baseline, post-EVT, and four-month follow-up. Wound severity was classified by wound area and wound, ischemia, and foot infection (WIfI) score. Wound StO2 increased significantly (median (interquartile range (IQR)), 38 (49.3) to 60 (34.5)%, p = 0.004), as did wound area StO2 (median (IQR), 70.9 (21.6) to 72.8 (18.3)%, p < 0.001), with no significant changes in the control group by four-month follow-up. Wound area decreased significantly after EVT (mean ± SD, 343.1 ± 267.8 to 178.1 ± 268.5 mm2, p = 0.01) but not in the control group. Changes in wound StO2, wound area StO2, and WIfI score correlated with wound area reduction, unlike ABI. This small exploratory study shows that NIRS-measured StO2 improvements after EVT correlate with reduced wound area and WIfI scores, highlighting NIRS as a potential enhancement for CLTI wound management in addition to ABI. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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9 pages, 1295 KiB  
Brief Report
Results of the Phase 1 Open-Label Safety Study of Umbilical Cord Lining Mesenchymal Stromal/Stem Cells (Corlicyte®) to Heal Chronic Diabetic Foot Ulcers
by Cecilia C. Low Wang, Tae Chong, Garrett Moore, Benjamin Echalier, Nicola Haakonsen, James E. Carter, Jr., David Mathes, Judith Hsia, Toan Thang Phan, Ivor J. Lim and Brian M. Freed
Biomedicines 2024, 12(6), 1375; https://doi.org/10.3390/biomedicines12061375 - 20 Jun 2024
Cited by 2 | Viewed by 2306
Abstract
Background: Mesenchymal stromal/stem cells (MSCs) play a critical role in wound healing. Corlicyte® is an MSC product derived from allogeneic umbilical cord tissue donated under an institutional review board-approved protocol and processed in accordance with section 501(a)(2)(B) of the Federal Food, Drug, [...] Read more.
Background: Mesenchymal stromal/stem cells (MSCs) play a critical role in wound healing. Corlicyte® is an MSC product derived from allogeneic umbilical cord tissue donated under an institutional review board-approved protocol and processed in accordance with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. This open-label phase 1 trial was performed under a United States Food and Drug Administration Investigational New Drug Application to establish the safety and tolerability of Corlicyte® in patients with diabetes and chronic diabetic foot ulcer (DFU). Methods: Escalating doses were applied topically twice a week for up to 8 weeks after ulcer debridement, wound photography, and measurement. Subjects were followed for 4 weeks after the treatment phase. Adverse events were assessed at every visit. Results: Nine subjects in 2 dosing cohorts completed the trial. No subjects experienced a serious adverse reaction to Corlicyte® or the development of anti-human leukocyte antigen (HLA) antibodies. Sixty percentage of subjects in the lower dose cohort experienced ulcer closure by Day 70 of follow-up, while the mean ulcer size was reduced by 54–67% in the other subjects. Conclusions: Topical administration of Corlicyte®, a novel biologic therapy consisting of allogeneic umbilical cord lining MSCs, appeared safe and tolerable and resulted in a significant decrease in ulcer area, demonstrating its potential as a therapy for healing of chronic DFU. Full article
(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))
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