The benefits of antimicrobial photodynamic therapy with RLP068 in the management of diabetic foot ulcers.

This article is the first part of a literature review concerning diabetic foot ulcers and the use of antimicrobial photodynamic therapy (PDT). Diabetic foot ulcers are associated with high morbidity, mortality, and healthcare costs. Natural healing is often delayed by microbial infection or colonisation, which might lead to serious complications, such as amputation. Furthermore, antibiotic treatment could have limited success because of the development of bacterial resistance and severely limited drug delivery to the ulcer due to vascular damage. PDT has antimicrobial effects and has been used to reduce the total and pathogenic microbial load in diabetic ulcers without inducing bacterial resistance. It is safe and can be used to improve outcomes. A clinical trial demonstrated that PDT with RLP068 reduced the microbial load of diabetic ulcers in 62 patients. This article reports previously published evidence and presents four, unpublished, clinical cases treated in the real-life setting.

The use of a dermal substitute to preserve maximal foot length in diabetic foot wounds with tendon and bone exposure following urgent surgical debridement for acute infection.

In this study, we evaluated the utility of a dermal substitute for preserving maximal foot length after urgent surgical debridement. Patients referred to our Diabetic Foot Center with foot lesions were assessed for sensory-motor neuropathy, infection and critical limb ischaemia. The presence of acute foot infection indicated the need for immediate surgical debridement. The degree of amputation, if necessary, was based on the amount of apparently non infected vital tissue. When vital tendon/bone tissue remained exposed, the lesion was covered with a dermal substitute. From January to December 2008, 393 patients underwent surgical treatment for diabetic foot syndrome; 30 patients underwent immediate surgical debridement resulting in exposed tendon and/or bone tissues. An average of 4.4 +/- 2.1 days following surgical debridement, all 30 patients underwent dermal regeneration template grafting to cover-exposed healthy tendon and bone tissues, instead of achieving primary wound closure with a proximal amputation. After 21 days, a skin graft was performed. Complete wound healing occurred in 26 patients (86.7%). In these patients, the amputation level was significantly more distal (P < 0.003) with respect to that potentially required for immediate wound closure. The average healing time was 74.1 +/- 28.9 days. Four patients underwent a more proximal amputation. No patients underwent major amputation. The use of the dermal substitute for treating exposed tendon and bone tissues allowed timely wound healing and preserved maximal foot length. Continued follow-up will allow assessment of long-term relapse and complication rates. Such treatment could constitute part of the comprehensive management of diabetic wounds.

Evaluation of feasibility of ankle pressure and foot oximetry values for the detection of critical limb ischemia in diabetic patients.

A total of 261 diabetic patients were admitted because of rest pain and/or foot ulcer in 1 limb. Ankle pressure (AP) and transcutaneous oxygen tension (TcPO(2)) were measured, and digital subtraction arteriography was performed. Transcutaneous oxygen tension was <30 mm Hg in 213 patients and >or=30<50 mm Hg in 48 patients. Ankle pressure could not be measured in 109 patients. In 50 patients, AP was <70 mm Hg and in 102 patients, it was >or=70 mm Hg. Arteriography showed evidence of stenoses >50% of vessel lumen diameter in all patients. Major amputation was performed in 16 patients; AP was <70 mm Hg in 4 patients and >or=70 mm Hg in 6. It was not practicable in the remaining 6 patients. Transcutaneous oxygen tension was <30 mm Hg in 15 patients and >or=30 mm Hg in 1 patient. For diagnosis of critical limb ischemia (CLI) in diabetic patients presenting with rest pain or foot ulcer, measurement of TcPO( 2) is essential not only when AP is not measurable but also when this value is >or=70 mm Hg.

The use of a dermal substitute (integra) to preserve maximal foot length in a diabetic foot wound with bone and tendon exposure following urgent surgical debridement for an acute infection.

In this report, the authors present the case of a 62-year-old female patient who was admitted to our hospital with an acute deep foot infection. The patient was taken immediately to the operating room where she underwent surgical debridement to completely remove all infected tissues; at the end of this first surgical step, all 5 metatarsal bones remained exposed dorsally. Once eradication of infection was completed, we had to decide whether to perform a transmetatarsal amputation at proximal levels, which would have allowed healing by first intention but would have left the patient with a smaller foot stump, or amputation at more distal levels followed by coverage of healthy tendon and bone tissues with a dermal regeneration template (Integra, Integra Life Sciences Corporation, Plainsboro, NJ), which would have preserved the foot stump length and allowed better walking. We opted for the second choice, and the use of a dermal template actually enabled our patient to maintain a considerable foot stump length, much longer than would have resulted from an amputation with immediate primary closure.

Long-term prognosis of diabetic patients with critical limb ischemia: a population-based cohort study.

OBJECTIVE: To evaluate the long-term prognosis of critical limb ischemia (CLI) in diabetic patients. RESEARCH DESIGN AND METHODS: A total of 564 consecutive diabetic patients were hospitalized for CLI from January 1999 to December 2003; 554 were followed until December 2007. RESULTS: The mean follow-up was 5.93 +/- 1.28 years. Peripheral angioplasty (PTA) was performed in 420 (74.5%) and bypass graft (BPG) in 117 (20.6%) patients. Neither PTA nor BPG were possible in 27 (4.9%) patients. Major amputations were performed in 74 (13.4%) patients: 34 (8.2%) in PTA, 24 (21.1%) in BPG, and 16 (59.2%) in a group that received no revascularization. Restenosis occurred in 94 patients, bypass failures in 36 patients, and recurrent ulcers in 71 patients. CLI was observed in the contralateral limb of 225 (39.9%) patients; of these, 15 (6.7%) required major amputations (rate in contralateral compared with initial limb, P = 0.007). At total of 276 (49.82%) patients died. The Cox model showed significant hazard ratios (HRs) for mortality with age (1.05 for 1 year [95% CI 1.03-1.07]), unfeasible revascularization (3.06 [1.40-6.70]), dialysis (3.00 [1.63-5.53]), cardiac disease history (1.37 [1.05-1.79]), and impaired ejection fraction (1.08 for 1% point [1.05-1.09]). CONCLUSIONS: Diabetic patients with CLI have high risks of amputation and death. In a dedicated diabetic foot center, the major amputation, ulcer recurrence, and major contralateral limb amputation rates were low. Coronary artery disease (CAD) is the leading cause of death, and in patients with CAD history the impaired ejection fraction is the major independent prognostic factor.

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.

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.

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.

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.

The role of early surgical debridement and revascularization in patients with diabetes and deep foot space abscess: retrospective review of 106 patients with diabetes.

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.