Chiara Goretti

Effectiveness and Safety of a Novel Gel Dressing in the Management of Neuropathic Leg Ulcers in Diabetic Patients: A Prospective Double-Blind Randomized Trial

Neuropathic leg ulcers (NLUs) affect more than 10% of diabetic patients with peripheral neuropathy and represent the most common cause of ulceration of the leg in these patients. Though their pathogenesis is well known, related to the chronic neuropathic edema, the management of NLUs, mainly based on elastocompression, is still controversial, with lower healing rates than nondiabetic venous leg ulcers. The authors tested if a novel gel formulation, containing amino acids and hyaluronic acid (Vulnamin® gel; Errekappa, Milan, Italy), will improve the outcomes of NLUs when used together with elastocompression. Thirty patients affected by NLU were randomized into 2 groups, both treated with 4-layer elastocompressive bandaging: patients in group A were topically treated with the application of Vulnamin® gel, whereas patients in group B received only the inert gel vehicle. The healing rate at 3 months was evaluated as the primary endpoint, whereas the secondary endpoints were healing time, reduction in ulcer area and ulceration score in 4 weeks, number of infective complications, and overall satisfaction of patients. Healing rate was significantly (P < .05) higher in patients in group A when compared with those in group B; healing time, patients’ satisfaction, and reduction in ulcer area and ulceration score in 4 weeks were also higher in patients in group A. However, no significant differences were found in the prevalence of infections and other adverse events. The use of Vulnamin ® gel with elastocompression is safe and effective in the management of NLUs of diabetic patients.

Outcomes of three years of teamwork on critical limb ischemia in patients with diabetes and foot lesions

To evaluate the outcomes of a multidisciplinary team working on diabetic foot (DF) patients with critical limb ischemia (CLI) in a specialized center, the authors retrospectively traced all the patients admitted in their department in 3 consecutive years with a diagnosis of CLI. From January 2006 to December 2008, 245 consecutive DF patients with CLI according the TransAtlantic interSociety Consensus II criteria were included in the study. Treatment strategy was decided by a team of diabetologists, inteventional radiologists, and vascular surgeons. Technical and clinical success, mortality, and ulcer recurrence were evaluated at 6 months and at a mean follow-up of 19.5 ± 13.4 months. Percutaneous transluminal angioplasty (PTA) was performed in 189 (77%) patients, whereas medical treatment, open surgical revascularization (OSR), and primary amputation were performed in 44 (18.3%), 11 (4.3%), and 1 (0.5%) patients, respectively. Revascularization was successful in 227/233 (97.4%) patients. At follow-up, the overall clinical success rate was 60.4%; it was significantly (P = .001) higher after revascularization (75.9%) compared with medical treatment (48.3%). During follow-up, surgical interventions in the foot were 1.5 ± 0.4 in those treated with PTA, 1.6 ± 0.5 in those treated with OSR, and 0.3 ± 0.8 in those receiving medical therapy (P < .05 compared with the others). Ulcer recurrence occurred in 29 (11.8%) patients: 4 (1.6%) in PTA, 2 (0.8%) in OSR, and 23 (9.4%) in the medical therapy group (P < .05). Major amputation rate was 9.3%, being significantly (P = .04) lower after revascularization (5.2%) compared with medical therapy alone (13.8%). Cumulative mortality rate was 10.6%. In conclusion, this study confirms the positive role of a PTA-first approach for revascularizing the complex cases of DF with CLI in a teamwork management strategy.

Clinical Outcomes of Wide Postsurgical Lesions in the Infected Diabetic Foot Managed With 2 Different Local Treatment Regimes Compared Using a Quasi-Experimental Study Design: A Preliminary Communication

The safety and efficacy of a novel superoxidized solution (Dermacyn™ Wound Care [DWC], Oculus Innovative Sciences, Petaluma, Calif) was evaluated for the treatment of wide postsurgical infected ulcers of the diabetic foot. A group (group A,n = 18) of patients with diabetes mellitus who had postsurgical lesions>5 cm2 without ischemia or infection were recruited consecutively and treated with DWC-saturated dressings. These dressings were renewed once daily and were compared with a group of patients that had been previously treated with diluted povidone iodine (group B,n = 15) using a quasi-experimental study design. Both sets of patients also received standard systemic antibiotic therapy, as per the practice in this center, and local surgical debridement. Patients had weekly assessments until wounds had re-epithelialized completely. Patients in group A had statistically significant shorter healing time and duration of antibiotic therapy and a higher healing rate at 6 months compared with those in group B (p < .01). Recurrence of infection, requirement for debridement procedures, and requirement for minor amputations were significantly less frequent during follow-up in group A patients (p < .05) when compared with those in group B. These preliminary data suggest that DWC used as a wound dressing together with other local and systemic therapies may have a role in reducing healing time as well as complications in patients with diabetes who have postsurgical lesions of the diabetic foot. These data propose the need for a robust controlled study of DWC-saturated dressings to explore its full potential.

Comparison of Removable and Irremovable Walking Boot to Total Contact Casting in Offloading the Neuropathic Diabetic Foot Ulceration

Background: Despite its efficacy in healing neuropathic diabetic foot ulcers (DFUs), total contact cast (TCC) is often underused because of technical limitations and poor patient acceptance. We compared TCC to irremovable and removable commercially available walking boots for DFU offloading. Methods: We prospectively studied 60 patients with DFUs, randomly assigned to 3 different offloading modalities: TCC (group A), walking boot rendered irremovable (i-RWD; group B), and removable walking boot (RWD; group C). Patients were followed up weekly for 90 days or up to complete re-epithelization; ulcer survival, healing time, and ulcer size reduction (USR) were considered for efficacy, whereas number of adverse events was considered for safety. Patients’ acceptance and costs were also evaluated. Results: Mean healing time in the 3 groups did not differ (P = .5579), and survival analysis showed no difference between the groups (logrank test P = .8270). USR from baseline to the end of follow-up was significant (P < .01) in all groups without differences between the groups. Seven patients in group A (35%), 2 in group B (10%), and 1 in group C (5%) (Fisher exact test P = .0436 group A vs group C) reported nonsevere adverse events. Patients’ acceptance and costs were significantly better in group C (P < .05). Conclusions: Our results suggest that a walking boot was as effective and safe as TCC in offloading the neuropathic DFUs, irrespective of removability. The better acceptability and lesser costs of a removable device may actually extend the possibilities of providing adequate offloading. Level of Evidence: Level II, prospective comparative study.

Safety and Effectiveness of Therapeutic Magnetic Resonance in the Management of Postsurgical Lesion of the Diabetic Foot

To evaluate the safety and effectiveness of therapeutic magnetic resonance (TMR) in the management of the diabetic foot (DF), we treated a group of consecutive type 2 diabetic inpatients with wide postsurgical lesions (Group A: N = 10; age 67.7 ± 18.9 years, duration of diabetes 22.3 ± 6.6 years, 8.1 ± 1.1%, body mass index 29.4 ± 2.1 kg/m2), for 2 consecutive weeks, while admitted, with a low-intensity magnetic resonance equipment, in addition to standard treatment. Patients, compared with a matched control group with the same clinical characteristics (Group B), were then followed monthly for 6 months to evaluate healing rate (HR), healing time (HT), rate of granulation tissue (GT) at 3 months, and adverse events. HR was of 90% in Group A and 30% in Group B (P < .05); GT was 73.7 ± 13.2% in Group A versus 51.84 ± 18.77% in Group B (P < .05). HT in Group A was 84.46 ± 54.38 days versus 148.54 ± 78.96 days in Group B (P < .01). No difference in adverse events (5 in Group A and 6 in Group B) was observed throughout the study period. In this pilot study, the use of TMR at this dose and duration was safe. The results also permit the observation that TMR plus standard care offered a faster healing rate compared with standard care alone.

Necrotizing Fasciitis and The Diabetic Foot

Necrotizing fasciitis (NF) represents a rapidly progressive, life-threatening infection involving skin, soft tissue, and deep fascia. An early diagnosis is crucial to treat NF effectively. The disease is generally due to an external trauma that occurs in predisposed patients: the most important risk factor is represented by diabetes mellitus. NF is classified into 3 different subtypes according to bacterial strains responsible: type 1 associated to polymicrobial infection, type 2 NF, generally associated to Streptococcus species, often associated to Staphylococcus aureus and, eventually, Type 3, due to Gram-negative strains, such as Clostridium difficile or Vibrio. NF is usually characterized by the presence of the classic triad of symptoms: local pain, swelling, and erythema. In daily clinical practice immune-compromised or neuropathic diabetic patients present with atypical symptomatology. This explains the high percentage of misdiagnosed cases in the emergency department and, consequently, the worse outcome presented by these patients. Prompt aggressive surgical debridement and antibiotic systemic therapy are the cornerstone of its treatment. These must be associated with an accurate systemic management, consisting in nutritional support, glycemic compensation, and hemodynamic stabilization. Innovative methods, such as negative pressure therapy, once the acute conditions have resolved, can help fasten the surgical wound closure. Prompt management can improve prognosis of patients affected from NF reducing limb loss and saving lives.

Do You Want to Organize a Multidisciplinary Diabetic Foot Clinic? We Can Help

The diabetic foot (DF) is a complex pathology involving the lower limb of 8 to 10 million people around the world, and its prevalence is rising, creating a dramatic need for effective therapeutic answers. The multidisciplinary DF clinic has been proposed as a model to fight this complication from the International Working Group on Diabetic Foot (IWGDF) inside a more articulated 3-level organization strategy. The organization and technical aspects of this strategy, together with the characteristics of each of the 3 levels have been analyzed and described in the article, together with the aims and limitations of each of the levels to cope with a 3-dimensional pathology involving systemic, local, and logistic aspects. The implementation of this model in Europe produced positive results measured so far in at least 2 nationwide experiences, in Germany and in Italy, and it should be taken in account whenever health policies apply to the DF issue.

Treatment of diabetic foot ulcers with Therapeutic Magnetic Resonance (TMR®) improves the quality of granulation tissue

Diabetic foot ulcers (DFUs) often result in severely adverse outcomes, such as serious infections, hospitalization, and lower extremity amputations. In last few years, to improve the outcome of DFUs, clinicians and researchers put their attention on the application of low intensity pulsating electro- magnetic fields through Therapeutic Magnetic Resonance (TMRR). In our study, patients with DFUs have been divided into two groups: The Sham Group treated with non-functioning TMRR device, and the Active Group treated with a functioning device. Biopsies were recovered from ulcers before and after a 15-day treatment with both kind of TMRR device. To recognize signs of inflammation or healing process, the harvested biopsies were subjected to histological and molecular analyses. The histological analysis showed a change in cell population after treatment with TMRR: an increase of fibroblasts and endothelial cells with a reduction of inflammatory cells. After TMRR application, the gene expression profile analysis revealed an improvement in extracellular matrix components such as matrix metalloproteinases, collagens and integrins, a reduction in proinflammatory interleukins, and an increase in growth factors expression. In conclusion, our research has identified histological and molecular features of reduced inflammation and increased cell proliferation during the wound healing process in response to TMRR application.

The Use of a Novel Super-Oxidized Solution on Top of Standard Treatment in the Home Care Management of Postsurgical Lesions of the Diabetic Foot Reduces Reinfections and Shortens Healing Time

There are still many unmet needs in the treatment of chronic wounds, especially regarding microenvironment modulation. Nexodyn is a novel super-oxidized solution capable of contrast bacterial proliferation. We aimed to evaluate if this solution, on top of standard of care, was safe and effective in improving diabetic foot outcome. We selected 50 patients admitted in our department to be submitted to surgery for acute diabetic foot infection. All patients were left open to heal for secondary intent. We divided patients into 2 groups: Group A (n = 25, male/female = 17/8, age = 67.3 ± 12.1 years, hemoglobin A1C = 7.9 ± 1.1%), patients treated with standard of care and, on top of this, Nexodyn solution, and Group B, treated only with standard of care. After discharge, patients continued Nexodyn application. We followed up patients until complete healing or up to 6 months. No differences between groups in healing rate, while time required for complete healing was significantly shorter in Group A (64.9 ± 12.1 days vs 147.4 ± 23.1 days, P < .01). During follow-up, the group treated with Nexodyn showed a reduced rate of reinfections (12 patients in Group B vs 3 patients in Group A, P < .05) and of further debridement procedures (1 patient in Group A vs 10 patients in Group B, P < .05). Nexodyn provided effective protection against reinfections in diabetic foot patients, thus reducing the necessity for debridement procedures and their healing time and presents a safety profile similar to saline solution.

Type 2 diabetic patient with a foot ulcer as initial manifestation of diffuse large B-cell lymphoma: A case report

Diabetic foot ulcerations (DFU) represent a major cause of hospitalization and amputation. In people with diabetes its not uncommon to find chronic wounds due to pathogenic mechanisms different from diabetes. Here we report the case of a foot lesion misdiagnosed as DFU but actually caused by diffuse large B-cell lymphoma.