Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia

We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days ( P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.

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P3571Comparable limb salvage and amputation free survival in diabetic and non-diabetic patients with critical limb ischemia undergoing endovascular revascularization

European Heart Journal ◽

10.1093/eurheartj/ehy563.p3571 ◽

2018 ◽

Vol 39 (suppl_1) ◽

Author(s):

B P Y Yan ◽

W M Chan ◽

W H S Lai ◽

A O W Cheng ◽

C K Y Chan ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Diabetic Patients ◽

Free Survival ◽

Endovascular Revascularization

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Results of isolated infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia in high-risk diabetic patients

Vascular ◽

10.1177/1708538115619265 ◽

2016 ◽

Vol 24 (5) ◽

pp. 515-522 ◽

Cited By ~ 3

Author(s):

E Tartaglia ◽

A Lejay ◽

Y Georg ◽

M Roussin ◽

F Thaveau ◽

...

Keyword(s):

High Risk ◽

Limb Salvage ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Primary Patency ◽

Diabetic Patients ◽

Secondary Patency ◽

Cerebrovascular Event ◽

Arterial Lesions ◽

Infrapopliteal Angioplasty

Aim Infrapopliteal occlusive arterial lesions mostly characterize diabetic patients arteriopathy. Diabetic patients are prone to multiple comorbidities that make them candidates for low-invasive therapeutic options. The aim of this study was to evaluate the safety of infrapopliteal angioplasty in high-risk diabetic patients. Methods We undertook a study (retrospective study of a prospectively collected database) of all infrapopliteal endovascular revascularizations performed for critical limb ischemia in high-risk (≥3 major comorbidities) diabetic patients in our institution between 2008 and 2010. Study end points were safety, technical success rate, healing rate, overall 1-year survival, primary patency, secondary patency and limb salvage rates. Results A total of 101 high-risk diabetic patients (160 arterial lesions: 94 stenosis and 66 occlusions) underwent infrapopliteal endovascular surgery. No major adverse cardiovascular or cerebrovascular event was recorded within 30 days. Two major adverse limb events (two thromboses requiring major amputation) and seven minor adverse events were recorded. Technical and healing rates were, respectively, 83% and 78%. The 1-year survival, primary patency, secondary patency and limb salvage rates were, respectively, 86%, 67%, 83% and 84%. Conclusion Infrapopliteal angioplasty can be considered as a safe and feasible option for high-risk diabetic patients with critical limb ischemia.

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PS126. Limb Salvage and Survival Rate After Endovascular Treatment of Infrapopliteal Artery Occlusion in Diabetic Patients With Critical Limb Ischemia

Journal of Vascular Surgery ◽

10.1016/j.jvs.2010.02.149 ◽

2010 ◽

Vol 51 (6) ◽

pp. 54S

Author(s):

Francesco Setacci ◽

Pasqualino Sirignano ◽

Francesca Iacoponi ◽

Gianmarco de Donato ◽

Emiliano Chisci ◽

...

Keyword(s):

Survival Rate ◽

Endovascular Treatment ◽

Limb Salvage ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Artery Occlusion ◽

Diabetic Patients ◽

Infrapopliteal Artery

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Procalcitonin Is a Prognostic Marker of Hospital Outcomes in Patients with Critical Limb Ischemia and Diabetic Foot Infection

Journal of Diabetes Research ◽

10.1155/2019/4312737 ◽

2019 ◽

Vol 2019 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Marco Meloni ◽

Valentina Izzo ◽

Laura Giurato ◽

Enrico Brocco ◽

Michele Ferrannini ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Diabetic Foot ◽

Univariate Analysis ◽

Limb Ischemia ◽

Major Amputation ◽

Diabetic Patients ◽

Hospital Outcomes ◽

Diabetic Foot Infection ◽

The Mean

Aim. To evaluate the prognostic role of procalcitonin (PCT) in patients with diabetic foot infection (DFI) and critical limb ischemia (CLI). Materials and Methods. The study group was composed of diabetic patients with DFI and CLI. All patients were treated according to a preset limb salvage protocol which includes revascularization, wound debridement, antibiotic therapy, and offloading. Inflammatory markers, including PCT, were evaluated at admission. Only positive values of PCT, greater than 0.5 ng/ml, were considered. Hospital outcomes were categorized as limb salvage (discharge with preserved limb), major amputation (amputation above the ankle), and mortality. Results. Eighty-six patients were included. The mean age was 67.3±11.4 years, 80.7% were male, 95.1% had type 2 diabetes, and the mean diabetes duration was 20.5±11.1 with a mean HbA1c of 67±16 mmol/mol. 66/86 (76.8%) of patients had limb salvage, 7/86 (8.1%) had major amputation, and 13/86 (15.1%) died. Patients with positive PCT baseline values in comparison to those with normal values showed a lower rate of limb salvage (30.4 versus 93.6%, p=0.0001), a higher rate of major amputation (13 versus 6.3%, p=0.3), and a higher rate of hospital mortality (56.5 versus 0%, p<0.0001). At the multivariate analysis of independent predictors found at univariate analysis, positive PCT was an independent predictor of major amputation [OR 3.3 (CI 95% 2.0-5.3), p=0.0001] and mortality [OR 4.1 (CI 95% 2.2-8.3), p<0.0001]. Discussion. Positive PCT at admission increased the risk of major amputation and mortality in hospital patients with DFI and CLI.

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Superiority of Transcutaneous Oxygen Tension Measurements in Predicting Limb Salvage After Below-the-Knee Angioplasty: A Prospective Trial in Diabetic Patients With Critical Limb Ischemia

CardioVascular and Interventional Radiology ◽

10.1007/s00270-010-9968-x ◽

2010 ◽

Vol 34 (2) ◽

pp. 271-279 ◽

Cited By ~ 20

Author(s):

Ulf Redlich ◽

Yan Y. Xiong ◽

Maciej Pech ◽

Jörg Tautenhahn ◽

Zuhir Halloul ◽

...

Keyword(s):

Limb Salvage ◽

Oxygen Tension ◽

Critical Limb Ischemia ◽

Prospective Trial ◽

Limb Ischemia ◽

Diabetic Patients ◽

Transcutaneous Oxygen Tension ◽

Transcutaneous Oxygen ◽

Below The Knee

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Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience

Diabetic Foot & Ankle ◽

10.1080/2000625x.2019.1696012 ◽

2019 ◽

Vol 10 (1) ◽

pp. 1696012 ◽

Cited By ~ 3

Author(s):

Luca Dalla Paola ◽

Paolo Cimaglia ◽

Anna Carone ◽

Giuseppe Scavone ◽

Giulio Boscarino ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Diabetic Patients ◽

Specialized Center

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Limb Salvage in Diabetic Patients with No-Option Critical Limb Ischemia: Outcomes of a Single Center Experience

SSRN Electronic Journal ◽

10.2139/ssrn.3320178 ◽

2019 ◽

Author(s):

Luca Dalla Paola ◽

Paolo Cimaglia ◽

Anna Carone ◽

Giuseppe Scavone ◽

Giulio Boscarino ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Diabetic Patients ◽

Single Center ◽

Single Center Experience

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Direct Endovascular Revascularization Based on the Angiosome Model Reduces Risk of Major Amputations and Increases Life Expectancy in Type 2 Diabetic Patients with Critical Limb Ischemia and Foot Ulceration

Journal of the American Podiatric Medical Association ◽

10.7547/18-130 ◽

2021 ◽

Author(s):

Elisabetta Iacopi ◽

Alberto Coppelli ◽

Chiara Goretti ◽

Irene Bargellini ◽

Antonello Cicorelli ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Group Versus ◽

Limb Ischemia ◽

Major Amputation ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Endovascular Revascularization ◽

Indirect Revascularization ◽

Type 2 Diabetic

Background: We evaluated whether direct or indirect endovascular revascularization, based on angiosome model (AM), affects outcomes in type 2 diabetes (T2DM) and critical limb ischemia (CLI). Methods: From 2010 to 2015, 603 T2DM were admitted for CLI and submitted to endovascular revascularization. Among these, 314 (52%) underwent a direct and 123 (20%) an indirect revascularization, depending on whether the flow to the artery directly feeding the site of ulceration, according to the AM, whereas 166 patients (28%) were judged not revascularizable. Outcomes were: healing (HR), major amputation (MA) and mortality rates (MR), respectively. Results: An overall HR of 62.5% was observed: patients who did not receive PTA presented a HR of 58.4% (p< 0.02 vs revascularized patients). An higher HR was observed in the direct group versus indirect one (82.4% vs 50.4%. p<0.001). MA rate was significantly higher in indirect group than in direct one (9.2% vs 3.2%. p<0.05). MR was 21.6% and higher in indirect revascularization (24% vs 14% in direct group. p<0.05). Conclusions: Our data show that direct revascularization of arteries supplying the diabetic foot ulcers site by means of AM is associated with higher healing rate and lower risk of amputation and death as compared to indirect procedure. These results support use of AM in T2DM with CLI.

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Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia

Journal of Clinical Medicine ◽

10.3390/jcm10102213 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2213

Author(s):

Alessia Scatena ◽

Pasquale Petruzzi ◽

Filippo Maioli ◽

Francesca Lucaroni ◽

Cristina Ambrosone ◽

...

Keyword(s):

Peripheral Blood Mononuclear Cells ◽

Critical Limb Ischemia ◽

Diabetic Foot ◽

Peripheral Blood ◽

Mononuclear Cells ◽

Limb Ischemia ◽

Control Group ◽

Peripheral Blood Mononuclear ◽

Blood Mononuclear Cells

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan–Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.

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