Intermittent intravenous urokinase for critical limb ischemia in diabetic foot ulceration

2008 ◽  
Vol 100 (09) ◽  
pp. 475-482 ◽  
Author(s):  
Matthias Weck ◽  
Hannes Rietzsch ◽  
Holger Lawall ◽  
Uwe Pichlmeier ◽  
Peter Bramlage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Critical Limb Ischemia ◽  
Ulcer Healing ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Diabetic Patients ◽  
Foot Ulceration

SummaryPatients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in improving microcirculation in critical limb ischemia and might improve outcomes. There are no data on the efficacy and safety of urokinase treatment (survival free of major amputation, ulcer healing and the rate of minor and major bleeding). Therefore, we aimed to investigate the effect of urokinase treatment in a phase II clinical trial. We performed an open, prospective, non-controlled, multi-center phase II cohort study in 77 type-2 diabetic patients with critical limb ischemia and diabetic foot ulceration. Patients had no surgical or endovascular treatment option based on interdisciplinary consensus. Urokinase (1 Mio IU if plasma fibrinogen ≥2.5 g/l, 0.5 Mio IU if fibrinogen < 2.5 g/l) was administered for 21 days as an intravenous infusion over 30 minutes. Each patient was followed up for 12 months. Treatment for a median of 21 days resulted in 33% of patients being alive, having no major amputation and completely healed ulcers after 12 months. Total survival rate was 84.6%,amputation-free survival 69.2% and rate of major amputation 21.1%.Eighty-two percent of patients experienced at least once a complete ulcer healing within the course of study. Three serious adverse events were urokinase-related. Urokinase treatment in diabetic patients with critical limb ischemia appears to be effective, feasible and safe. Although this calls for a larger, randomized and controlled trial, the results are highly relevant for clinical practice to prevent these patients from receiving major amputation due to diabetic foot syndrome.Clinical Trial Registration No.: NCT00537498

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

2019 ◽  
Vol 2019 ◽  
pp. 1-5 ◽  
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.

scholarly journals Long-Term Outcomes of Diabetic Patients With Critical Limb Ischemia Followed in a Tertiary Referral Diabetic Foot Clinic

Diabetes Care ◽  
2010 ◽  
Vol 33 (5) ◽  
pp. 977-982 ◽  
Author(s):  
L. Uccioli ◽  
R. Gandini ◽  
L. Giurato ◽  
S. Fabiano ◽  
E. Pampana ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Diabetic Foot ◽  
Limb Ischemia ◽  
Diabetic Patients ◽  
Long Term Outcomes ◽  
Tertiary Referral ◽  
Foot Clinic

Mortality after major amputation in diabetic patients with critical limb ischemia who did and did not undergo previous peripheral revascularization

2010 ◽  
Vol 24 (4) ◽  
pp. 265-269 ◽  
Author(s):  
Ezio Faglia ◽  
Giacomo Clerici ◽  
Maurizio Caminiti ◽  
Vincenzo Curci ◽  
Jacques Clerissi ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Diabetic Patients

scholarly journals The Effect of Charcot Neuroarthropathy on Limb Preservation in Diabetic Patients with Foot Wound and Critical Limb Ischemia after Balloon Angioplasty

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Mehmet Burak Çildağ ◽  
Ömer Faruk Kutsi Köseoğlu
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Diabetic Foot ◽  
Limb Ischemia ◽  
Diabetic Patients ◽  
Charcot Neuroarthropathy ◽  
Below The Knee ◽  
Limb Preservation ◽  
Significant Difference ◽  
Patients With Diabetes

Objective. The aim of this article is to investigate one-year limb preservation rates after below-the-knee angioplasty in patients with diabetic foot wound who only have critical limb ischemia (CLI) and those who have Charchot neuroarthropathy (CN) accompanied by CLI. Methods. This single-center, retrospective study consists of 63 patients with diabetic foot wound who had undergone lower extremity balloon angioplasty of at least 1 below-the-knee (BTK) vessel. Only those patients with postprocedural technical success of 100% were selected from the database. All patients were classified into two groups as patients with CLI and CN and patients with CLI only without CN. The Kaplan-Meier method was used to compare the limb preservation rates for the two groups. Results. There was no statistically significant difference between patient age, gender, diabetic disease duration, and comorbid disease such as chronic renal insufficiency, hypertension, and coronary artery disease of the two groups (p>0.05). Limb preservation in the 12 months was 59.1% in the CN group and 92.7% in the group without CN. Also, limb preservation rates between the two groups displayed statistically significant differences (p<0.005). Conclusion. This study showed that CLI can accompany CN in patients with diabetes. Limb preservation rates with endovascular treatment in diabetic patients with CLI only are better than in diabetic patients with CLI and CN.

scholarly journals Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

2014 ◽  
Vol 78 (2) ◽  
pp. 490-501 ◽  
Author(s):  
Yasuyuki Fujita ◽  
Makoto Kinoshita ◽  
Yutaka Furukawa ◽  
Tohru Nagano ◽  
Hisako Hashimoto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cell Therapy ◽  
Phase Ii ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Phase Ii Clinical Trial

scholarly journals Factors Associated With Ulcer Healing and Quality of Life in Patients With Diabetic Foot Ulcer

Angiology ◽  
2016 ◽  
Vol 68 (3) ◽  
pp. 242-250 ◽  
Author(s):  
Konstantinos Spanos ◽  
Vasileios Saleptsis ◽  
Athanasios Athanasoulas ◽  
Christos Karathanos ◽  
Alexandra Bargiota ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcer Healing ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Major Amputation ◽  
Diabetic Patients ◽  
Factors Associated ◽  
Minor Amputation

A prospective nonrandomized cohort study on consecutive diabetic patients with foot ulcer was undertaken to assess the factors associated with the healing process or limb salvage and evaluate the impact of their treatment on their quality of life. Quality of life was evaluated using Diabetic Foot Ulcer Scale–Short Form (DFS-SF) questionnaire before and after treatment. A total of 103 diabetic patients with ulcer (mean age 69.7 ± 9.6 years, 77% male) were treated and followed up for 12 months. Ulcer healing, minor amputation, and major amputation rates were 41%, 41%, and 18%, respectively, while the mortality rate was 18%. Ulcer healing was associated with University of Texas wound grade 1 and the Study of Infections in Diabetic feet comparing Efficacy, Safety and Tolerability of Ertapenem versus Piperacillin/Tazobactam trial’s diabetic foot infection wound score. Limb loss was associated with nonpalpable popliteal artery, longer in-hospital stay, and delay until referral. Quality of life was improved in all domains of DFS-SF ( P < .0001) throughout the cohort of our patients regardless of their outcome, and no outcome (healing, minor amputation, or major amputation) was superior to other. Significant improvement was observed in all domains of hygiene self-management after consultation during the follow-up period.

scholarly journals Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

2020 ◽  
Vol 9 (11) ◽  
pp. 3745
Author(s):  
Marco Meloni ◽  
Valentina Izzo ◽  
Valerio Da Ros ◽  
Daniele Morosetti ◽  
Matteo Stefanini ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Major Amputation ◽  
Peripheral Arterial ◽  
Stage Renal Disease

The study aimed to evaluate clinical and vascular characteristics, as well as outcomes, for diabetic persons with foot ulceration and no-option critical limb ischemia (CLI). The study group included a sample of patients admitted to our diabetic foot unit because of a new diabetic foot ulcer and CLI. All subjects were managed using a limb salvage protocol which includes lower-limb revascularization. According to whether or not the revascularization procedure was a success, patients were respectively divided into two groups: successfully treated CLI patients (ST-CLI) and no-option CLI patients (NO-CLI). Failed revascularization was considered in the case of technical recanalization failure of occluded vessels (inability to overcome the obstruction) and/or absence of arterial flow to the foot. Limb salvage, major amputation, and death after 1 year of follow-up were evaluated and compared between the two groups. Overall, 239 patients were included, 74.9% belonging to ST-CLI and 25.1% to NO-CLI. NO-CLI patients reported more cases of ischemic heart disease (80 vs. 62.1, p = 0.008), heart failure (63.3 vs. 32.4%, p < 0.0001), and end-stage renal disease (ESRD) (60 vs. 25.7%) than ST-CLI patients. In addition, more vessels were affected in the NO-CLI group (5.2 ± 1.6 vs. 4 ± 1.5, p < 0.0001), and there was more involvement of tibio-peroneal trunk (50 vs. 30.2%, p = 0.006), anterior tibial (93.3 vs. 82.7, p = 0.03), posterior tibial (93.3 vs. 73.7%, p = 0.0005), peroneal (70 vs. 48%, p = 0.002), and below-the-ankle arteries (73.3 vs. 39.1%, p < 0.0001) than ST-CLI. The 1 year outcomes for the whole population were 69.9% limb salvage, 10.9% major amputation, and 19.2% death. The outcomes for NO-CLI and ST-CLI were, respectively, as follows: limb salvage (13.8 vs. 73.4%, p < 0.0001), amputation (30 vs. 4.5%, p = 0.0001), and mortality (50 vs. 8.9%, p < 0.0001). NO-CLI patients showed a more severe pattern of peripheral arterial disease (PAD) with distal arterial lesions and worse outcomes than ST-CLI.

Cell Therapy for Critical Limb Ischemia

Angiology ◽  
2015 ◽  
Vol 67 (5) ◽  
pp. 444-455 ◽  
Author(s):  
Aaron Liew ◽  
Vish Bhattacharya ◽  
James Shaw ◽  
Gerard Stansby
Keyword(s):  
Cell Therapy ◽  
Critical Limb Ischemia ◽  
Ulcer Healing ◽  
Mononuclear Cells ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Cochrane Library ◽  
Mortality Data ◽  
All Cause Mortality

Early-phase trials showed the feasibility and potential efficacy of cell therapy in patients with critical limb ischemia (CLI). For systematic review, randomized controlled trials (RCTs) of cell therapy versus no cell therapy in CLI were searched from PubMed and the Cochrane library databases. Outcome measures included major amputation, complete ulcer healing, ankle–brachial index (ABI), and all-cause mortality. Data were pooled using 16 RCTs, involving 774 patients. Compared with no cell therapy, cell therapy significantly reduced major amputation (odds ratio [OR]: 0.54; 95% CI: 0.34-0.87: P = .01) and improved ulcer healing (OR: 2.90; 95% confidence interval [CI]: 1.44-5.82; P < .01) and ABI (OR: 5.91; 95% CI: 1.85-18.86: P < .01). Peripheral blood-derived mononuclear cells (PB-MNCs; OR: 0.29; 95% CI: 0.12-0.72; P < .01) and bone marrow concentrate (OR: 0.44; 95% CI: 0.21-0.93; P = .03) significantly lowered the risk of major amputation. The PB-MNCs also significantly increased ulcer healing (OR: 5.77; 95% CI: 1.77-18.87; P < .01). All-cause mortality was similar in both groups (OR: 0.78; 95% CI: 0.44-1.40; P = .41). However, all estimates were nonsignificant following reanalysis using placebo-controlled RCTs only. Cell therapy remains a potential therapeutic option in CLI, but further larger placebo-controlled RCTs are needed.

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