Neuropathic Diabetic Foot Research Articles

Effective and Economic Offloading of Diabetic Foot Ulcers in India with the Bohler Iron Plaster Cast.

Economic constraints are a major obstacle to the implementation of offloading casts in India. The aim of this study is to monitor the healing and activity limitations related to Bohler iron plaster cast (BIPC) when used for offloading diabetic neuropathic plantar foot ulcers. Thirty patients were cast for 1month and evaluated for healing using the Pressure Ulcer Scale for Healing (PUSH), and for activity limitation using the Lower Extremity Functional Scale (LEFS). The change in the scores after intervention was the outcome measure. There was good healing as evidenced by a statistical difference in mean PUSH scores. The baseline PUSH score of 9.76-0.41 (T1-SEM) was greater than follow-up PUSH score of 6.32 + 0.41 (T2 + SEM) and the p value <0.0001. Improvement was seen in ulcer area, exudate, and tissue type. There was no mobility effect as there was no significant difference in LEFS. Significant negative correlation was there between PUSH and LEFS. The r value was less than -0.7 both at baseline and after intervention. The combined benefits of good healing, lack of affect on lower extremity function, the ease of application and dressing, and relative affordability make BIPC a commendable offloading modality for the management of diabetic plantar ulcers.

Clinical and morphological characteristics with markers of reparation in neuropathic diabetic foot ulcers.

Aim. To compare the clinical and morphological characteristics of chronic diabetic foot ulcers and the markers of repair.Materials and Methods.We included 26 patients with neuropathic diabetic foot syndrome who had signs of severe peripheral neuropathy. Biopsies were performed from the margin and central part of the lesion and were fixed in a 10% formalin solution before being placed on paraffin slides and stained with hematoxylin and eosin. We assessed the percentages of necrotic, granulation and fibrotic tissues and the severity of vascular hyalinosis. Immunohistochemistry was performed with initial antibodies to Ki-67 (a marker of proliferation), smooth muscle actin (a marker of myofibroblast synthesis) and cytokeratin (a marker of epithelisation). For analysis, the samples were divided into three groups by the length of time the ulcer had been present: group 1 (≤90 days; 9 samples), group 2 (91–365 days; 10 samples) and group 3 (365 days; 9 samples).Results. The patients of group 3 were older than those of groups 1 and 2 (53.7±2.7 vs 51.7±5.9 vs 59.9±5.6 years; p=0.04). There were no differences in the duration of diabetes, glycated haemoglobin or severity of neuropathy. The percentage of necrotic tissue was higher in group 1 (33.7%±21.7% vs 11.0%±3.9% vs 12.8%±6.1%; p=0.02) and the percentage of fibrotic tissue was highest in group 3 (21.1%±21.0% vs 35.5%±19.8% vs 54.4%±23.9%; p=0.001). However, the amount of granulation tissue was not different between the groups (45.2%±21.1% vs 53.5%±21.1% vs 32.8%±26.3%; p=0.4). There was also no difference in the severity of vascular hyalinosis between the groups (p=0.9). Expression of Ki-67 was higher in groups 1 and 2, implying a greater capacity to regenerate. The expression of smooth muscle actin and cytokeratin was higher in groups 1 and 2 but without statistical significance.Conclusion. The morphological characteristics and regenerative capacities of neuropathic diabetic foot ulcers differ with the duration the ulcer has been present. Patients with ulcers for less than 1 year were characterised by higher cell proliferation but lower fibrosis. Neuropathic diabetic foot ulcers that are unable to heal over a year are characterised by incomplete regeneration and higher levels of fibrosis. Thus, different treatment approaches are needed depending on how long an ulcer has been present.

Topical administration of a connexin43-based peptide augments healing of chronic neuropathic diabetic foot ulcers: A multicenter, randomized trial.

Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signalling accelerates wound reepithelialization. In a prospective, randomized, multicenter clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, alpha connexin carboxy-terminal (ACT1), in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care (SOC) protocols. Adults with DFUs of at least four weeks duration were randomized to receive SOC with or without topical application of ACT1. Primary outcome was mean percent ulcer reepithelialization and safety variables included incidence of treatment related adverse events (AEs) and detection of ACT1 immunogenicity. ACT1 treatment was associated with a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks (72.1% vs. 57.1%; p = 0.03). Analysis of incidence and median time-to-complete-ulcer closure revealed that ACT1 treatment was associated with a greater percentage of participants that reached 100% ulcer reepitheliazation and a reduced median time-to-complete-ulcer closure. No AEs reported were treatment related, and ACT1 was not immunogenic. Treatment protocols that incorporate ACT1 may present a therapeutic strategy that safely augments the reepithelialization of chronic DFUs.

Comparison of Arthrodesis with Total Contact Casting for Midfoot Ulcerations Associated with Charcot Neuroarthropathy.

BackgroundGross deformity of the foot in Charcot neuroarthropathy can lead to foot collapse and subsequent ulceration, infection, amputation, or premature death. Total-contact casting (TCC) is a well-established treatment for neuropathic diabetic plantar foot ulcers. It was hypothesized that arthrodesis plus TCC may have advantages over TCC alone. This pilot study compared the effectiveness of arthrodesis plus TCC with TCC alone for the prevention, treatment, and recurrence of midfoot ulcerations associated with Charcot neuroarthropathy.Material/MethodsTwenty-one subjects with plantar ulcers associated with unilateral diabetic Charcot midfoot neuroarthropathy were randomly assigned to ADS or TCC groups. The ADS group underwent an extended medial column arthrodesis procedure and TCC; ulcers were sutured directly. The TCC group underwent TCC alone with dressing changes. All patients underwent nerve conduction studies and quantitative sensory testing at baseline and during follow-up (6 and 12 months). Healing time and ulcer relapse rate were evaluated.ResultCompared with the TCC group, there were fewer lesions in the ADS group after treatment (P<0.05). Temperature testing and vibration perception threshold improved significantly after ADS (P<0.05). Although the number of patients positive for pinprick and light touch sensations increased after surgery, not all patients recovered these sensations. Healing time was not significantly different between the 2 groups (24.25±3.89 vs. 25.89±2.84 days, P>0.05). There was no ulcer recurrence after 12 months in the ADS group compared with 33.3% in the TCC group.ConclusionsAn extended medial column arthrodesis may partly improve sensory impairments and restore protective sensation in patients with Charcot neuroarthropathy.

Cultures of Diabetic Foot Ulcers Without Clinical Signs of Infection Do Not Predict Outcomes

We examined associations between ulcer bioburden and ulcer outcomes in neuropathic diabetic foot ulcers (DFUs) that lacked clinical signs of infection. Three dimensions of bioburden (i.e., microbial load, microbial diversity, and the presence of likely pathogens) were measured at baseline using swab cultures obtained by Levine's technique. Subjects were assessed every 2 weeks for 26 weeks to determine the rate of healing and development of infection-related complications. Foot ulcers were off-loaded using total-contact casts and routinely debrided. To establish associations between bioburden and rate of healing, Cox proportional hazards and least squares regression were used after adjusting for ulcer depth, surface area, and duration. A total of 77 subjects completed the study. Sixty-five (84.4%) had ulcers that healed during follow-up; weeks-to-closure ranged from 2 to 26 (median 4.0). Mean (± SD) percent reduction in surface area/week was 25.0% (± 23.33). Five (6.5%) of the DFUs developed an infection-related complication. None of the bioburden dimensions (i.e., microbial load, microbial diversity, or presence of likely pathogens) was significantly associated with weeks-to-closure or percent reduction in surface area per week. Weeks-to-closure was best predicted by ulcer duration, depth, and surface area (c-statistic = 0.75). Culturing DFUs that showed no clinical signs of infection had no predictive value for outcomes of DFUs managed with total-contact casts and routine debridement. These findings support recommendations of the Infectious Disease Society of America that culturing and antibiotics should be avoided in treating DFUs that show no clinical signs of infection.

Clinical Efficacy and Safety of a New Method for Pressure Off-load for Patients with Diabetic Foot Syndrome: Ankle-foot Pneumoorthosis with TM Orlett

Aim. The purpose of this study was to assess the clinical efficacy, safety and consumer properties of ankle-foot pneumoorthosis with a HAS-337 TM Orlett compared with non-removable total contact cast (TCC) immobilization. Materials and methods. Our study included 40 patients with diabetes mellitus type 1 (DM1) and type 2 (DM2) with neuropathic diabetic foot syndrome and chronic uninfected wounds of the plantar surface of the forefoot, with wound duration of at least 3 weeks, wound areas not less than 1 cm2 and wound depths not more than stage II based on Wagner?s classification. We excluded patients with infected wounds, osteomyelitis, Charcot osteoarthropathy or peripheral vascular disease. Our test group included 20 patients who received pressure off-load using ankle-foot pneumoorthosis with a HAS-337 TM Orlett. For a control group (n = 20), pressure off-load was achieved using TCC immobilization. Both groups were comparable with regard to age, gender, duration and degree of diabetes compensation and by original wound defect sizes (p &gt;0.05). The study duration was 6 months. Plantar pressure was measured inside the orthosis or TCC and was compared with test shoe measurements. Our major criteria for pressure relief were reduced pressures in the wound area and the whole foot and the rate of wound healing. Results. At the end of the 6-month period, complete healing of all ulcers was achieved. The average healing time was 46.1?19.0 days for the test group and was 48.3?20.5 days for the control group (p &gt;0.05). Two patients who wore pneumoorthosis with HAS-337 were discontinued upon patient request. With pneumoorthosis, the maximum peak pressure on the foot and wound defect areas was reduced by 26% and 57%, respectively. The pressure/time integral decreased on average by 41% (p &gt;0.05). Furthermore, in the midfoot area with pneumoorthosis, the maximum pressure increased by 48% and the pressure/time integral increased by 47%. Conclusions. Using pneumoorthosis with HAS-337 was an effective and safe method for pressure off-load, resulting in 100% healing of uninfected neuropathic ulcers of the plantar surface of the forefoot. However, pneumoorthosis with HAS-337 is not recommended for those patients with wound defects in the midfoot and heel areas.

3D finite element model of the diabetic neuropathic foot: A gait analysis driven approach

Diabetic foot is an invalidating complication of diabetes that can lead to foot ulcers. Three-dimensional (3D) finite element analysis (FEA) allows characterizing the loads developed in the different anatomical structures of the foot in dynamic conditions. The aim of this study was to develop a subject specific 3D foot FE model (FEM) of a diabetic neuropathic (DNS) and a healthy (HS) subject, whose subject specificity can be found in term of foot geometry and boundary conditions. Kinematics, kinetics and plantar pressure (PP) data were extracted from the gait analysis trials of the two subjects with this purpose. The FEM were developed segmenting bones, cartilage and skin from MRI and drawing a horizontal plate as ground support. Materials properties were adopted from previous literature. FE simulations were run with the kinematics and kinetics data of four different phases of the stance phase of gait (heel strike, loading response, midstance and push off). FEMs were then driven by group gait data of 10 neuropathic and 10 healthy subjects. Model validation focused on agreement between FEM-simulated and experimental PP.The peak values and the total distribution of the pressures were compared for this purpose. Results showed that the models were less robust when driven from group data and underestimated the PP in each foot subarea. In particular in the case of the neuropathic subject׳s model the mean errors between experimental and simulated data were around the 20% of the peak values. This knowledge is crucial in understanding the aetiology of diabetic foot.

Interest of the apparatus in the treatment of plantar neuropathic diabetic foot ulcers. About 120 patients

Interest of the apparatus in the treatment of plantar neuropathic diabetic foot ulcers. About 120 patients

Easy ways to offload diabetic foot ulcer in rural setup

Diabetic wound management has become a foremost problem in recent era. Offloading is one of the cornerstones of gold-standard treatment in diabetic neuropathic foot ulcer. The following article reviews the easily made offloading systems which are ideal to use in rural setup to offload diabetic foot ulcer.

The Difoprev&amp;reg; system in treatment of the skin of the elderly: preliminary data obtained in patients with dryness and hyperkeratosis

The Difoprev® system in treatment of the skin of the elderly: preliminary data obtained in patients with dryness and hyperkeratosis Leonardo AluigiCenter and School of Echography, Department of Internal Medicine, Maggiore Hospital, Bologna, ItalyBackground: Aging brings with it a number of structural and functional modifications of the skin and adnexa, particularly in the lower extremities, which may determine a gradual reduction in elasticity, with associated functional alterations which may determine preulcerative lesions. The aim of this study was to test the efficacy of the Difoprev® system, consisting in a sock functioning as a vehicle for microcapsules containing moisturizing agents (Pseudoalteromonas ferment extract, a glycoprotein synthesized by the bacterium, Pseudoalteromonas antarctica NF3). The system is already widely used for cutaneous treatment in cases of neuropathic diabetic foot, and in prevention/treatment of dryness and hyperkeratosis of the skin of the lower extremities in elderly persons (shin/foot).Methodology: Sixteen patients aged >70 years (group A) were treated with the Difoprev® system for 8 weeks. This group was compared with 8 patients of the same age (group B) who wore the same type of sock without microcapsules. Following initial assessment at the time of recruitment, the patients underwent controls at 15, 30, and 60 days to assess the degree of hydration of the skin derived from an objective evaluation of degree of keratosis according to an arbitrary scale of seriousness ranging from 1 (absent) to 4 (marked). The changes were rated according to a scale ranging from 1 (no improvement) to 5 (marked improvement). A comparative study of all cases was conducted by means of photographs taken as the treatment commenced and on termination of treatment.Results: Most patients treated with Difoprev® presented a reduction in the degree of keratosis of the skin (90%, of whom 15% had marked improvement), compared to the patients who wore only the sock with no microcapsules (10% with slight improvement). None of the patients undergoing Difoprev® system treatment displayed signs of intolerance or untoward reactions.Conclusion: While the clinical assessment was conducted on a small number of patients, the results obtained nevertheless demonstrate that the Difoprev® system is a safe, simple method for obtaining improvements to the skin of elderly people by reduction of the degree of keratosis through enhanced hydration.Keywords: nanotechnologies, cutaneous hydration, hyperkeratosis, ulcerative lesions

Ulcer piercing: Cleansing of complicated diabetic neuropathic foot ulcers by positive pressure irrigation

To demonstrate the efficacy of the ulcer piercing procedure, which allows constant cleansing of the ulcer and facilitates a positive pressure irrigation of any pierced hidden tracts, in order to reduce the negative impact of stasis on wound healing. We designed a surgical procedure of ulcer piercing and drainage with a silastic tube, which allows positive pressure irrigation of any pierced tracts. This procedure was performed in a continuous series of 25 selected diabetic patients affected by a Wagner stage 3 ulcer of the toe (n=16), metatarsal midfoot (n=5) and plantar Charcot foot (n=4), and with adequate foot arterial blood supply. Within 6 months of the ulcer piercing procedure, 23/25 of ulcers had completely healed. In two further cases, the ulcer piercing ring was still in place after 3 and 5 months, progressively healing with no active signs of infection. Taking into consideration the advantages and the lack of side effects afforded by this procedure, ulcer piercing represents a small but effective step towards an easier and safer approach to treating complicated diabetic neuropathic foot ulcers with adequate arterial blood supply. There were no external sources of funding for this study. The author has no conflicts of interest to declare with regard to the manuscript or its content.

Patients' Experience of therapeutic footwear whilst living at risk of neuropathic diabetic foot ulceration: an interpretative phenomenological analysis (IPA).

BackgroundPrevious work has found that people with diabetes do not wear their therapeutic footwear as directed, but the thinking behind this behaviour is unclear. Adherence to therapeutic footwear advice must improve in order to reduce foot ulceration and amputation risk in people with diabetes and neuropathy. Therefore this study aimed to explore the psychological influences and personal experiences behind the daily footwear selection of individuals with diabetes and neuropathy.MethodsAn interpretative phenomenological analysis (IPA) approach was used to explore the understanding and experience of therapeutic footwear use in people living at risk of diabetic neuropathic foot ulceration. This study benefited from the purposive selection of a small sample of four people and used in-depth semi structured interviews because it facilitated the deep and detailed examination of personal thoughts and feelings behind footwear selection.FindingsFour overlapping themes that interact to regulate footwear choice emerged from the analyses: a) Self-perception dilemma; resolving the balance of risk experienced by people with diabetes and neuropathy day to day, between choosing to wear footwear to look and feel normal and choosing footwear to protect their feet from foot ulceration; b) Reflective adaption; The modification and individualisation of a set of values about footwear usage created in the minds of people with diabetes and neuropathy; c) Adherence response; The realignment of footwear choice with personal values, to reinforce the decision not to change behaviour or bring about increased footwear adherence, with or without appearance management; d) Reality appraisal; A here and now appraisal of the personal benefit of footwear choice on emotional and physical wellbeing, with additional consideration to the preservation of therapeutic footwear.ConclusionFor some people living at risk of diabetic neuropathic foot ulceration, the decision whether or not to wear therapeutic footwear is driven by the individual ‘here and now’, risks and benefits, of footwear choice on emotional and physical well-being for a given social context.

A Longitudinal Investigation into the Functional and Physical Durability of Insoles Used for the Preventive Management of Neuropathic Diabetic Feet

Insoles are commonly used to assist in the prevention of diabetic neuropathic foot ulceration. Insole replacement is often triggered only when foot lesions deteriorate, an indicator that functional performance is comprised and patients are exposed to unnecessary ulcer risk. We investigated the durability of insoles used for ulcer prevention in neuropathic diabetic feet over 12 months. Sixty neuropathic individuals with diabetes were provided with insoles and footwear. Insole durability over 12 months was evaluated using an in-shoe pressure measurement device and through repeated measurement of material depth at the first metatarsal head and the heel seat. Analysis of variance was performed to assess change across time (at issue, 6 months, and 12 months). Analyses were conducted using all available data (n = 43) and compliant data (n = 18). No significant difference was found in the reduction of mean peak pressure tested across time (P < .05). For both sites, significant differences in insole depth were identified between issue and 6 months and between issue and 12 months but not between 6 and 12 months (P < .05). Most insole compression occurred during the initial 6 months. Visual material compression does not seem to be a reliable indicator of insole usefulness. Frequency of insole replacement is best informed by a functional review of effect determined using an in-shoe pressure measurement system. These results suggest that insoles for diabetic neuropathic patients can be effective in maintaining peak pressure reduction for 12 months regardless of wear frequency.

Improving outcomes in diabetic foot surgery after the implementation of measures for diagnosis and treatment

Diabetes is considered a worldwide health problem, and diabetic foot ulcers are considered important complications of this disease. Evaluation of treatment outcomes of operated neuropathic diabetic foot, following major amputation rate, number of days of hospitalization and postoperative complications. In this study we compared a control group (retrospective) from 2007-2010, consisting of 124 patients with neuropathic diabetic foot and a group of 106 patients, analyzed over a period of 3 years (2011-2013), after the implementation of a multidisciplinary diagnosis and treatment program of patients with lesions classified by the Wagner classification as - 1,2,3,4,5 lessions. After implementation of these measures for diagnosis and treatment in the study group we were able to decrease the rate of major amputation (neuropathic forms) from 10.48% (control group), to 2,83 % (the study group) also average length of stay was decreased from 11 days (control group) to 9 days. Postoperative complications decreased significantly in the study group. Therefore, implementation of complex diagnosis and treatment teams for lesions of diabetic foot insure a significant decrease of postoperative complications, major amputation rate and reduced length of stay.

Limb salvage and vascular augmentation by microsurgical free flap transfer for treatment of neuropathic diabetic foot ulcers

Neuropathic diabetic foot ulcers are generally deep and infectious wounds extending to the bone or joint. We performed microsurgical free flap transfer for limb salvage and vascular augmentation of feet with diabetic neuropathy. Angiography was performed to identify any significant arterial disease. The free flaps were transplanted after resection of the damaged skin and infected bone. Flow-through or end-to-side anastomosis to the dorsalis pedis artery was performed to preserve the arterial blood flow to the residual foot. An anterolateral thigh flap and free flaps based on the subscapular artery system were transplanted in 1 and 10 patients, respectively. All flaps survived. Arterial flow on the distal side of the anastomosis was postoperatively confirmed in all patients. During a mean follow-up period of 52 months, the long-term complications observed were recurrent ulcers in 4 patients. The limb salvage rate was 100%, and 82% of patients achieved functional ambulation. Microsurgical flap transplantation is a safe and useful technique for minimal amputation of a diabetic neuropathic foot. Postoperative protection of the feet is important in order to avoid recurrence of foot ulceration. The use of protective footwear custom-tailored for each patient is strongly recommended.

PS8 - 4. The relation between peak pressure parameters in removable offloading devices and healing of neuropathic diabetic foot ulcers

Foot ulceration is the most costly complication of diabetes. The gold standard for healing foot ulcers on the plantar side of the foot is offloading by means of a non-removable total contact cast (TCC). Because of known complications with a TCC, removable alternatives have been developed.

Prevention and management of neuropathic diabetic foot ulcers

Peripheral neuropathy is a common complication of diabetes that can reduce patients' quality of life, and is a major risk factor for foot ulceration and limb amputation. This article outlines the aetiological and pathological factors involved in the development of diabetic foot ulceration through the use of a case study. The role of diabetes foot screening is explored as a preventive measure, and the importance of risk assessment and stratification, and appropriate referral are discussed.

The Charcot Foot

Charcot joint is an uncommon but often missed complication of the neuropathic diabetic foot. Prompt recognition and treatment with plantar pressure redistribution can prevent unnecessary amputation.

Enhanced foot muscle strength and plantar pressure in the neuropathic diabetic foot

Magnetic resonance imaging (MRI) studies have been demonstrated that the diabetes-induced reduction in motor nerve function is closely related to impaired muscle energy metabolism, fatty infiltrati...

Foot Care

Foot Care