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Le Pubblicazioni
Int J Low Extrem Wounds. 2012 Oct 21. [Epub ahead of print]
Revascularization by Angioplasty of Type D Femoropopliteal and Long Infrapopliteal Lesion in Diabetic Patients With Critical Limb Ischemia: Are TASC II Recommendations Suitable? A Population-Based Cohort Study.
Faglia E, Clerici G, Airoldi F, Tavano D, Caminiti M, Curci V, Mantero M, Morabito A, Edmonds M.
J Foot Ankle Surg. 2012 Sep-Oct;51(5):593-8. doi: 10.1053/j.jfas.2012.05.015. Epub 2012 Jul 11.
Feasibility and effectiveness of internal pedal amputation of phalanx or metatarsal head in diabetic patients with forefoot osteomyelitis.
Faglia E, Clerici G, Caminiti M, Curci V, Somalvico F.
Catheter Cardiovasc Interv. 2012 Jun 1;79(7):1188-93. doi: 10.1002/ccd.23361. Epub 2012 Jan 10.
Retrograde popliteal access as bail-out strategy for challenging occlusions of the superficial femoral artery: a multicenter registry.
Sangiorgi G, Lauria G, Airoldi F, Godino C, Politi L, Colombo A, Clerici G, Modena MG, Biondi-Zoccai G.
J Foot Ankle Surg. 2012 Jan-Feb;51(1):34-8.
Prognostic difference between soft tissue abscess and osteomyelitis of the foot in patients with diabetes: data from a consecutive series of 452 hospitalized patients.
Faglia E, Clerici G, Caminiti M, Curci V, Somalvico F.
Cardiovasc Revasc Med. 2012 Jan;13(1):20-4. doi: 10.1016/j.carrev.2011.10.003. Epub 2011 Nov 23.
Antegrade approach for percutaneous interventions of ostial superficial femoral artery: outcomes from a prospective series of diabetic patients presenting with critical limb ischemia.
Airoldi F, Faglia E, Losa S, Tavano D, Latib A, Lanza G, Clerici G.
Diabetes Res Clin Pract. 2012 Mar;95(3):364-71. Epub 2011 Nov 21.
Limb revascularization feasibility in diabetic patients with critical limb ischemia: results from a cohort of 344 consecutive unselected diabetic patients evaluated in 2009.
Faglia E, Clerici G, Losa S, Tavano D, Caminiti M, Miramonti M, Somalvico F, Airoldi F.
J Cardiovasc Med (Hagerstown). 2008 Oct;9(10):1030-6.
Advantages of myocardial revascularization after admission for critical limb ischemia in diabetic patients with coronary artery disease: data of a cohort of 564 consecutive patients.
Faglia E, Clerici G, Caminiti M, Quarantiello A, Curci V, Morabito A.
AIM: To evaluate the survival benefit from myocardial revascularization in diabetic patients with critical limb ischemia and coronary artery disease (CAD) in a consecutive series of 564 diabetic patients hospitalized from 1999 to 2003 and followed up until December 2005.
METHODS: Three hundred and thirteen patients had a history of CAD, 60 of them (19.2%) with previous myocardial revascularization. Sixty-one patients with an ejection fraction of 40% or less underwent subsequent myocardial revascularization. Five hundred and fifty-seven patients (98.8%) were followed up until December 2005, including 310 of the 313 patients with a history of CAD.
RESULTS: One hundred and ten patients died because of CAD, 25 of the 251 patients without a history of CAD and 85 of the 313 patients with a history of CAD. Specifically, 74 (86.9%) of these 85 deaths occurred in the 192 patients without previous myocardial revascularization, nine (10.7%) in the 60 patients with previous myocardial revascularization, and two (2.4%) in the 61 patients in whom myocardial revascularization was performed after hospital admission for critical limb ischemia. The Cox model showed significant hazard ratio for mortality associated with age [hazard ratio 1.06 for 1 year, P = 0.003, confidence interval (CI) 1.02-1.09], history of CAD (hazard ratio 2.16, P < 0.001, CI 1.53-3.06), dialysis (hazard ratio 3.52, P < 0.001, CI 2.08-5.97), and impaired ejection fraction (hazard ratio 1.08 for one point percentage, P < 0.001, CI 1.05-1.09). Myocardial revascularization appeared to have a protective role: hazard ratio 0.29, P < 0.001, CI 0.33-0.93.
CONCLUSION: Paying attention to CAD in diabetic patients during their hospitalization for critical limb ischemia is useful for a subsequent myocardial revascularization, and it may increase survival in these patients.
Eur J Vasc Endovasc Surg. 2008 Jun 4
Angioplasty for Diabetic Patients with Failing Bypass Graft or Residual Critical Ischemia after Bypass Graft.
Faglia E, Clerici G, Clerissi J, Caminiti M, Quarantiello A, Curci V, Losa S, Vitiello R, Lupattelli T, Somalvico F.
OBJECTIVE: To evaluate the efficacy of peripheral angioplasty (PTA) in the treatment of diabetic patients with previous peripheral bypass graft and recurrent critical limb ischemia (CLI).
METHODS: Between January and December 2006, 293 diabetic patients presenting with critical limb ischemia (CLI) according to the TASC 2000 criteria were admitted to our footcare centre. Among these patients, 32 of them had previously undergone bypass grafting: femoropopliteal in 26 patients, femoroposterior tibial in 3 patients, femoroperoneal in the remaining 3. All these patients underwent angiography and, whenever possible, a concomitant PTA procedure.
RESULTS: Six patients presented with stenosis at the distal anastomosis, 2 with stenosis at the proximal anastomosis and in 5 patients both the distal and proximal anastomosis were stenosed. In 12 patients the graft was completely occluded. In 7 patients the graft appeared patent but all the infrapopliteal arteries were occluded. The average time interval between bypass and subsequent hospital admission because of CLI was 6.3+/-4.2 months for patients with patent grafts and 20.5+/-12.0 months for those with failing grafts (p=0.004). A successful PTA was performed in 25 patients (78.1%). In all patients with patent grafts, PTA recanalized one infrapopliteal artery. Recanalization of the graft was obtained in all 13 patients with non-occluded graft. Recanalization of superficial femoral artery occlusion by means of PTA was obtained in 5 out of the 12 patients in whom the graft was completely occluded. Five patients underwent major amputation within 30 days and 3 further patients during the follow-up period. Patients were followed up until December 31 2007, with a mean follow-up of 1.89+/-0.27 years. Restenosis occurred in 7 (28.0%) of the 25 patients in whom a successful PTA was performed. In 5 of these 7 patients, PTA was repeated successfully. In 2 patients in whom a further PTA was not feasible a major amputation was performed. At the end of the follow-up period the cumulative primary patency rate was 72%, the assisted patency rate was 92%.
CONCLUSIONS: PTA is an effective method for revascularizing secondary obstructions in patients with graft failure (and no possibility of a redo graft). PTA also is effective in at least one subgenicular artery in patients with diabetes with inadequate run-off after femoropopliteal bypass grafting.
J Vasc Surg. 2008 Feb 21
The efficacy and safety of closure of brachial access using the AngioSeal closure device: Experience with 161 interventions in diabetic patients with critical limb ischemia.
Lupattelli T, Clerissi J, Clerici G, Minnella DP, Casini A, Losa S, Faglia E.
Interventional Radiology Department, Sesto San Giovanni Milan, Italy.
PURPOSE: This study retrospectively evaluated the efficacy and safety of the 6F Angio-Seal (St. Jude Medical, St. Paul, Minn) as a closure device for transbrachial artery access for endovascular procedures in diabetic patients with critical limb ischemia.
METHODS: From January 2005 and September 2007, 1887 diabetic patients underwent interventional procedures in the lower limbs at a two diabetic foot centers. Patients presented with rest pain (16%), ulcers (80%), or gangrene (4%). Systemic anticoagulation with sodium heparin (70 IU/kg) was obtained for all patients at the beginning of the endovascular treatment. A total of 249 brachial arteries (238 patients) were evaluated for possible Angio-Seal use after endovascular recanalization of the leg. Color Doppler ultrasound imaging of the artery was obtained before revascularization only in patients with previous Angio-Seal placement in the brachial artery. No further imaging studies were done in the remaining brachial arteries where the Angio-Seal was deployed at the operator's discretion. Impairment or disappearance of the radial pulse or onsets of hand ischemia or hand pain, or impairment of hand function during or at the end of the endovascular revascularization were all regarded as contraindications to Angio-Seal usage. Evidence of a highly calcified plaque of the brachial artery access site at the time of vessel puncture was regarded as an absolute contraindication to the Angio-Seal use. Patients were seen before discharge, at 1, 3, and 8 weeks after the procedure, and at 3-month intervals thereafter. Complications included hemorrhage, pseudoaneurysm, infection, and vessel occlusion.
RESULTS: A total of 1947 Angio-Seal collagen plugs were deployed in 1709 diabetic patients (90.5%). The Angio-Seal was used for brachial artery closure in 159 patients (8.4%) in 161 procedures (159 in the left, 2 in the right brachial artery). In 79 patients (4.2%) in 88 procedures (87 in the left and 1 in the right brachial artery), the device was deemed contraindicated due to small vessel size in 73 patients (92.4%) or presence of calcium at the access site in five patients (6.3%). One patient (1.3%) refused the collagen plug closure after revascularization. The non-Angio-Seal group was evaluated for comparison. The success rate for achieving hemostasis in the Angio-Seal group was 96.9%. Five major complications (3.1%) at 30 days consisted of two puncture site hematomas >4 cm, two brachial artery occlusions, and one brachial artery pseudoaneurysm, with three patients requiring open surgery. Minor complications (7.50%) were three puncture site hematomas < 4 cm, three oozing of blood from the access site, and six patients had mild pain in the cubital fossa. No further complications were recorded in the 14-month follow-up (range 1-25 months) of a total of 140 patients.
CONCLUSIONS: This retrospective study shows that the 6F Angio-Seal is a valuable and safe vascular closure device for transbrachial access in diabetic patients undergoing interventional procedures for critical limb ischemia.
Diabet Med. 2007 Aug;24(8):823-9. Epub 2007 Jun 8.
When is a technically successful peripheral angioplasty effective in preventing above-the-ankle amputation in diabetic patients with critical limb ischaemia?
Faglia E, Clerici G, Clerissi J, Mantero M, Caminiti M, Quarantiello A, Curci V, Lupattelli T, Morabito A.
Diabetology Centre-Diabetic Foot Centre- IRCCS Multimedica, Sesto San Giovanni, Milan, Italy. ezio.faglia@multimedica.it
AIM: To determine parameters predictive of avoidance of major (above-the-ankle) amputation after a technically successful peripheral angioplasty (PTA) in patients with diabetes with critical limb ischaemia.
METHODS: From January 1999 to December 2003, 420 consecutive patients with diabetes admitted to hospital because of critical limb ischaemia underwent peripheral angiography and concomitant technically successful PTA. Transcutaneous oxygen tension (TcPO(2)) was measured before and after PTA. Major amputation at 30 days was recorded.
RESULTS: After PTA, the iliac-femoral-popliteal axis was patent in all patients. In 67 patients, all three crural arteries were patent, in 143 patients 2 crural arteries were patent, and in 186 patients one crural artery was patent (104 peroneal, 62 anterior tibial, 20 posterior tibial). In 24 patients, all three crural arteries were occluded. Twenty-two major amputations were performed. Of these, 15 were performed in the 24 patients with occlusion of all the infrapopliteal arteries. Seven of the 186 patients in whom only the peroneal artery was patent required amputation. In patients not requiring amputation, TcPO(2) increased from 15.5 +/- 11.9 to 45.0 +/- 12.0 mmHg (P = 0.000), while in those requiring amputation, TcPO(2) increased from 9.6 +/- 7.7 to 18.6 +/- 8.1 mmHg (P < 0.082). Multivariate analysis indicated an independent role of occlusion of infrapopliteal arteries after PTA (OR 8.20 for every crural obstructed artery, P = 0.022, CI 1.35-49.6) and TcPO(2) after PTA (OR 0.80 for increase of 1 mmHg, P < 0.001, CI 0.74-0.88).
CONCLUSIONS: In patients with diabetes, PTA is effective in avoiding major amputation, provided recanalization occurs in at least one tibial artery down to the foot. In a few patients, re-canalization of the peroneal artery alone is not sufficient to avoid major amputation.
Diabetes Res Clin Pract. 2007 Sep;77(3):445-50. Epub 2007 Feb 21.
Incidence of critical limb ischemia and amputation outcome in contralateral limb in diabetic patients hospitalized for unilateral critical limb ischemia during 1999-2003 and followed-up until 2005.
Faglia E, Clerici G, Mantero M, Caminiti M, Quarantiello A, Curci V, Morabito A.
Diabetology Centre-Diabetic Foot Centre, IRCCS Multimedica, Via Milanese 300, 20099 Sesto San Giovanni (Milan), Italy. ezio.faglia@multimedica.it
We studied the incidence of critical limb ischemia (CLI) and amputation outcome of the contralateral limb in 533 diabetic patients hospitalized in our diabetic foot centre because of CLI from 1999 to 2003 and followed-up until 2005. The cumulative incidence rate during the 6-year period reached 49.8% (CI confidence interval=40.6-59.6). All patients underwent arteriography and in 181 (98.4%) the revascularization was performed without different feasibility (p=0.077) compared to that (95.3%) in the initial patients. The severity of lesion evaluated with Wagner grade was lower (chi(2)=33.5, p<0.001) and also the frequency of midfoot and above-the-ankle amputations was lower (p<0.001 and p=0.022, respectively) in contralateral patients. There was no evidence from the logistic analysis to support the association between any of the investigated variables and incidence of CLI in the contralateral limb. Over a 6-year period, almost 50% of the diabetic patients with unilateral CLI developed a CLI in the contralateral limb: however, both severity of foot lesion and amputation level was significantly lower. This fact can be due to prompt therapeutic interventions, made possible thanks to an increased patient awareness acquired by training during the treatment of the unilateral limb.
Eur J Vasc Endovasc Surg. 2007 Feb 9.
Predictive Values of Transcutaneous Oxygen Tension for Above-the-ankle Amputation in Diabetic Patients with Critical Limb Ischemia.
Faglia E, Clerici G,Caminiti M,Quarantiello A, Curci V, Morabito A.
Diabetology Center-Diabetic Foot Center, IRCCS Multimedica, Sesto San Giovanni, Milano, Italy.
OBJECTIVE: To assess the values of transcutaneous oxygen tension (TcPO(2)) capable of predicting
above-the-ankle amputation in diabetic patients diagnosed for critical limb ischemia (CLI) according
to the criteria of the TransAtlantic Inter-Society Consensus.
DESIGN: Retrospective study.
METHODS: From January 1999 to December 2003, 564 diabetic patients were consecutively hospitalized
for CLI in one limb. Revascularization with angioplasty or bypass graft was performed when possible
and, if not possible, prostanoid therapy was used. In patients in whom therapies did not relieve the
rest pain or the gangrene was extended above the Chopart joint, an above-the-ankle-amputation was
performed. After treatment TcPO(2) values were evaluated in all patients at the dorsum of the foot.
RESULTS: Fifty-five (9.8%) patients underwent an above-the-ankle amputation: 22 of 420 patients who
underwent angioplasty, 17 of 117 patients who underwent bypass (14.5%) and 16 of 27 patients in whom
revascularization was not possible. Post-treatment TcPO(2), measured by a receiver operating
characteristic (ROC) curve, showed a value 34mmHg as the best threshold for determining the need for
revascularization, with an area under the curve of 0.89 (95%CI 0.85-0.94). Using logistic regression
analysis the probability of above-the-ankle amputation for this threshold is 9.7% and reduces to 3%
for TcPO(2)>40mmHg.
CONCLUSION: TcPO(2) levels <34mmHg indicate the need for revascularization, while for values >/= 34<40mmHg
this need appears less pressing, although there remains a considerable probability of amputation. TcPO(2)
levels greater than 40mmHg suggest that revascularization is dependent on the severity of tissue loss and
possible morbidity caused by the procedure.
Diabetes Res Clin Pract. 2007 Feb 20
Incidence of critical limb ischemia and amputation outcome in contralateral limb in diabetic patients hospitalized for unilateral critical limb ischemia during 1999-2003 and followed-up until 2005.
Faglia E, Clerici G,Mantero M,Caminiti M,Quarantiello A, Curci V, Morabito A.
Diabetology Center-Diabetic Foot Center, IRCCS Multimedica, Sesto San Giovanni, Milano, Italy.
We studied the incidence of critical limb ischemia (CLI) and amputation outcome of the contralateral
limb in 533 diabetic patients hospitalized in our diabetic foot centre because of CLI from 1999 to 2003
and followed-up until 2005.
The cumulative incidence rate during the 6-year period reached 49.8% (CI confidence interval=40.6-59.6).
All patients underwent arteriography and in 181 (98.4%) the revascularization was performed without
different feasibility (p=0.077) compared to that (95.3%) in the initial patients.
The severity of lesion evaluated with Wagner grade was lower (chi(2)=33.5, p<0.001) and also the frequency
of midfoot and above-the-ankle amputations was lower (p<0.001 and p=0.022, respectively) in contralateral
patients.
There was no evidence from the logistic analysis to support the association between any of the investigated
variables and incidence of CLI in the contralateral limb. Over a 6-year period, almost 50% of the diabetic
patients with unilateral CLI developed a CLI in the contralateral limb: however, both severity of foot
lesion and amputation level was significantly lower.
This fact can be due to prompt therapeutic interventions, made possible thanks to an increased patient
awareness acquired by training during the treatment of the unilateral limb.
J Foot Ankle Surg. 2006 Jul-Aug;45(4):220-6.
The role of early surgical debridement and revascularization in patients with diabetes and deep foot space abscess: retrospective review of 106 patients with diabetes.
Faglia E, Clerici G,Caminiti M,Quarantiello A, Gino M, Morabito A.
Diabetology Unit-Diabetic Foot Center, IRCCS Policlinico Multimedica, Sesto San Giovanni, Milan, Italy. [ezio.faglia@multimedica.it]
One hundred-six patients underwent emergency debridement of a deep foot space abscess.
While 43 patients were admitted after an outpatient visit with immediate surgical debridement (group A),
63 patients were transferred from other hospitals after a mean stay of 6.2+/-7.5 days without debridement
(group B).
No significant differences were observed in the demographic and clinical features between the 2 groups,
except for the following differences in group B: higher blood glucose level on admission (P=.015), lower
serum albumin level (P=.005), and a more frequent extension of the infection to the heel (P=.005).
Eradication of the infection was obtained in group A without amputation in 9 patients, with an amputation
of 1 or more rays in 21, with metatarsal amputations in 12, and with a Chopart amputation in 1.
In group B, incision and drainage alone were performed in 4 patients, amputation of 1 or more rays in 21,
metatarsal amputations in 10, Chopart amputations in 23, and an above-the-ankle amputation in 5.
The amputation level was significantly more proximal in group B (chi2=24.4, P<.001).
There was no significant difference in the presence of peripheral arterial occlusive disease between
the 2 groups (P=.841). Regression logistic analysis showed a significant relationship between the amputation
level and the number of days elapsed before debridement (odds ratio, 1.61; P=.015; confidence interval,
1.10-2.36), but not with the presence of peripheral occlusive disease (odds ratio, 1.73; P=.376;
confidence interval, 0.29-15.3).
These data show that a delay in the surgical debridement of a deep space abscess increases the amputation
level. Accuracy in the diagnosis of peripheral occlusive disease and immediate revascularization yield
similar outcomes in patients with or without peripheral occlusive disease.
Eur J Vasc Endovasc Surg. 2006 Nov;32(5):484-90. Epub 2006 May 26.
Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort study of 564 patients.
Faglia E, Clerici G, Clerissi J, Gabrielli L, Losa S, Mantero M, Caminiti M, Curci V, Lupattelli T, Morabito A.
Diabetology Centre-Diabetic Foot Centre, Policlinico Multimedica, Sesto San Giovanni (Milano), Italy. [ezio.faglia@multimedica.it]
OBJECTIVE: To evaluate the early and late major amputation and survival rates and related risk factors in
diabetic patients with critical limb ischemia (CLI).
DESIGN: Retrospective study.
METHODS: Revascularization feasibility, major amputation, survival rate and related risk factors were
recorded in 564 diabetic patients consecutively hospitalized for CLI from 1999 to 2003 and followed
until June 2005.
RESULTS: Peripheral angioplasty (PTA) was carried out in 420 (74.5%), bypass graft (BPG) in 117 (20.7%)
patients. In 27 (4.8%) patients both PTA and BPG were not possible. Twenty-three above-the-ankle
amputations (4.1%) were performed at 30 days: 6 in PTA patients, 3 in BPG patients, 14 in non
revascularized patients. In the follow-up of 558 patients (98.9%), 62 repeated PTAs and 9 new BPGs,
32 new major amputations (16 in PTA patients, 14 in BPG patients and 2 in non-revascularized patients)
were performed. Major amputation was associated with absence of revascularization (OR 35.9, p < 0.001,
CI 12.9-99.7), occlusion of each of the three crural arteries (OR 8.20, p = 0.022, CI 1.35-49.6),
wound infection (OR 2.1, p = 0.004 CI 1.3-3.6), dialysis (OR 4.7, p = 0.001 CI 1.9-11.7) increase
in TcPO2 after revascularization (OR 0.80, p < 0.001 CI 0.74-0.87). One hundred seventy three patients
died during follow-up and this was associated with age (HR 1.05, p < 0.001 CI 1.03-1.07), history of
cardiac disease (HR 2.16, p < 0.001 CI 1.53-3.06), dialysis (HR 3.52, p < 0.001 CI 2.08-5.97), absence
of revascularization (HR 1.68, p < 0.001, CI 1.29-2.19) and impaired ejection fraction (HR 1.08,
p < 0.001, CI 1.05-1.09).
CONCLUSIONS: In diabetic patients with CLI the revascularization is feasible in most cases and allows a
low rate of early major amputation. This rate is higher in the follow-up period. Major amputation is
very high in patients where revascularization is not feasible while the high mortality rate is due to
the serious comorbidities observed in these patients.
Eur J Vasc Endovasc Surg.2005 Jun;29(6):620-7. Epub 2005 Mar 28.
Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003.
Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, Gabrielli L, Losa S, Stella A, Gargiulo M, Mantero M, Caminiti M, Ninkovic S, Curci V, Morabito A.
Diabetology Centre, Diabetic Foot Centre, Policlinico Multimedica, 20099 Sesto S. Giovanni, Milano, Italy. [ezio.faglia@multimedica.it]
OBJECTIVE: To evaluate the effectiveness of peripheral angioplasty (PTA) as the first-choice
revascularisation procedure in diabetic patients with critical limb ischemia (CLI).
DESIGN: Prospective study. METHODS: PTA was employed as first choice revascularisation in a
consecutive series of diabetic patients hospitalized for CLI between January 1999 and December 2003.
RESULTS: PTA was successful performed in 993 patients. Seventeen (1.7%) major amputations were
carried out. One death and 33 non-fatal complications were observed. Mean follow-up was 26+/-15 months.
Clinical restenosis was observed in 87 patients. The 5 years primary patency was 88%,
95% CI 86-91%. During follow-up 119 (12.0%) patients died at a rate of 6.7% per year.
CONCLUSIONS: PTA as the first choice revascularisation procedure is feasible, safe and
effective for limb salvage in a high percentage of diabetic patients. Clinical restenosis
was an infrequent event and PTA could successfully be repeated in most cases.
Diabetes Care. 2003 Oct;26(10):2853-9.
HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial.
Caravaggi C, De Giglio R, Pritelli C, Sommaria M, Dalla Noce S, Faglia E, Mantero M, Clerici G, Fratino P, Dalla Paola L, Mariani G, Mingardi R, Morabito A.
Centre for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso, Milan, Italy. [carlo.caravaggi@fastwebnet.it]
OBJECTIVE: To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 79 patients with diabetic dorsal (n = 37) or plantar (n = 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n = 36) or the treatment group with autologous tissue-engineered grafts (n = 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events. RESULTS: Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P = 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P = 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P = 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments. CONCLUSIONS: The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied.
Diabetes Care. 2003 Jun;26(6):1874-8.
Ulcer recurrence following first ray amputation in diabetic patients: a cohort prospective study.
Dalla Paola L, Faglia E, Caminiti M, Clerici G, Ninkovic S, Deanesi V.
Diabetic Foot Unit, Presidio Ospedaliero Abano Terme, Padova, Italy. [ldallapaola@libero.it]
OBJECTIVE: To evaluate the reulceration and reamputation rates in a cohort of diabetic patients
following first ray amputation.
RESEARCH DESIGN AND METHODS: We evaluated a cohort of 89 diabetic patients, 63 men and 26 women,
who underwent first ray amputation in the period from January 2000 to December 2001.
The first ray lesions were Wagner grade 2 in 3 patients, Wagner grade 3 in 47 patients, and Wagner grade
4 in 39 patients. Following surgical wound healing, all patients wore special footwear with rocker
bottom soles and custom molded insoles and were put on an intensive secondary prevention program.
RESULTS: The mean follow-up duration was 16.35 +/- 6.76 months (range 7-28). Fifteen patients
developed new ulcerations, with 11 lesions occurring ipsilaterally and 4 contralaterally to the first
ray amputation. In seven patients, the new lesion was treated and healed with dressing. Eight patients
underwent a new surgical procedure: panmetatarsal head resection in four patients, toe amputation in
two patients, a transmetatarsal amputation in one patient, and Lisfranc's amputation in one patient.
CONCLUSIONS: In the population studied, the first ray amputation presented a lower reulceration and
reamputation rate with respect to that reported in the literature. This finding should therefore be
attributed to the follow-up program, which uses shoes with a rocker bottom sole and custom molded insoles
and intensive ambulatory check-ups.
J Intern Med. 2002 Sep;252(3):225-32.
Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects.
Faglia E, Mantero M, Caminiti M, Caravaggi C, De Giglio R, Pritelli C, Clerici G, Fratino P, De Cata P, Dalla Paola L, Mariani G, Poli M, Settembrini PG, Sciangula L, Morabito A, Graziani L.
Internal Medicine Unit, Diabetology Centre, Policlinico Multimedica, Sesto San Giovanni, Milano, Italy. [ezio.faglia@multimedica.it]
OBJECTIVE: To evaluate the feasibility, technical effectiveness and limb salvage potential
of percutaneous transluminal angioplasty (PTA), particularly infrapopliteal, in diabetic
subjects with ischaemic foot ulcer.
DESIGN: Intervention study with PTA in consecutive series.
SETTING: Six Diabetology Foot Centres and one Cardiovascular Catheterization Laboratory in Italy.
SUBJECTS: Two hundred and twenty-one consecutive diabetic subjects hospitalized for ischaemic
foot ulcer.
INTERVENTION: Peripheral arterial occlusive disease (PAOD) was investigated by means of foot pulses
assessment, ankle-brachial-index (ABI), transcutaneous oxygen tension (TcPO2) and duplex scanning.
If non-invasive parameters suggested PAOD, angiography was performed and a PTA was carried out
during the same session.
MAIN OUTCOME MEASURES: PTA feasibility, improvement of ABI and TcPO2, limb salvage rate, clinical
recurrence.
RESULTS: On angiography, two patients had stenoses which were <50% of the vessel diameter.
PTA was performed in 191 (85.3%) of the 219 subjects with stenoses >50%, even when longer than 10 cm
and/or multiple/calcified. In 11 patients (5.8%) PTA was performed in the proximal axis
exclusively, in 81 (42.4%) patients in the infrapopliteal axis exclusively and in 99 (51.8%)
in both the femoropopliteal and infrapopliteal axis. Both ABI and TcPO2 improved significantly
after PTA (P < 0.0001). Clinical recurrence occurred in 14 subjects: 10 of whom underwent a
second successful PTA. Of the 191 patients who underwent PTA, 10 (5.2%) underwent an
above-the-ankle amputation.
CONCLUSIONS: PTA, including infrapopliteal, is feasible in most diabetic subjects with ischaemic foot
ulcer and is effective for foot revascularization. Clinical recurrence was infrequent and the procedure
could successfully be repeated in most cases. In subjects treated successfully with PTA the
above-the-ankle amputation rate was low. PTA should be considered as the revascularization treatment
of first choice in all diabetic subjects with foot ulcer and PAOD.
c/o IRCCS Policlinico Multimedica, Via Milanese 300 - Sesto S. Giovanni (MI)