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Bariatric Management of the Neuropathic Limb: Implications for Action in Overweight Children and Obese Adults with Diabetes

Kathy L. Cisney, MSN, APRN-BC, CWOCN, CPed

Diabetes and the escalating numbers of overweight adults and children are priority health concerns. From 1991 to 2001, diagnosed diabetes (including gestational) increased 61%, whereas obesity increased 74%, demonstrating the correlation between obesity and the development of diabetes in the United States.¹ Body mass index (BMI) is a tool used to determine weight status and varies among age groups.^2,3 For adults older than 20 years, a BMI between 25.0 and 29.9 is considered overweight and 30.0 or above obese.² In children and teens, the BMI is gender and age specific, recognizing differences in growth patterns and development. The weight status classification for youth denotes "at risk for overweight" and "overweight," rather than "obese" as in adults. At risk for overweight is a BMI for age that falls between the 85th and 95th percentiles. Overweight is defined as a BMI for age in the 95th percentile and above.⁴

Data from the Centers for Disease Control (CDC) Behavioral Risk Factor Surveillance Systems (BRFSS) indicate a substantial rise from 1985 to 2002 in the number of states reporting obesity. In 2002, the prevalence of obesity in 50 states was 15% or higher. Of those, 29 states had rates of 20 to 24% with three states more than 25%.⁵ Recent data specific to obesity and diabetes have prevalence for overweight plus obese adults totaling 67.1%.⁶ Overweight and obesity are significantly associated with diabetes, as well as other health-related risk factors in the adult population.⁷

Information from the National Health and Nutrition Examination Surveys (NHANES) indicated a growth in prevalence of overweight among children and adolescents over time. The prevalence of overweight for ages 6 to 19 years remained fairly stable from the 1960s to 1980, with 7%, for children 6 to 11 years, being the highest prevalence during that period. Results from the 1999 to 2000 NHANES revealed 15% as overweight in children ages 6 to 19 years, a difference of 8% from 1980.⁸ The National Youth Risk Behavior Surveillance System (YRBSS) reported an increase in students grade 9 through 12 at risk for overweight from 2001 to 2003. High school students at risk of overweight equaled 13.6% and overweight 10.5% in the United States according to YRBSS for that time frame.⁹ CDC's Pediatric Nutrition Surveillance System estimated overweight children younger than 5 years at 14.3% in the United States for 2002.¹⁰ Type 2 diabetes is the main health risk for overweight children and youth.⁶

Diabetes is a disabling and deadly disease effecting more than 18 million Americans. The number of US adults with diagnosed diabetes has increased 61% during the last 13 years and is projected to more than double by 2050. Type 1 and type 2 diabetes are the two main forms, with type 1 developing primarily during childhood or adolescence. Type 2 diabetes is related to being overweight or obese and usually appears among people older than 40 years. With the increasing prevalence of overweight children, type 2 diabetes is no longer considered an adult-only disease.¹¹ The prevalence of diagnosed diabetes among people younger than 20 years in the United States increased in 2002, representing approximately 206,000.¹² The highest prevalence of type 2 diabetes exists in American Indian youths aged 15 to 19 years. Children and adolescents with type 2 diabetes diagnosed usually are aged 10 to 19 years, obese, and with a strong family history for type 2 diabetes. Poor glycemic control (A1c = 10–12%) is common among children and adolescents with type 2 diabetes.¹³ Although it is recognized that type 2 diabetes is a problem among youth, national data are lacking.¹² Type 2 diabetes is difficult to detect in children, so the magnitude of the disease probably is underestimated.¹³

Comorbidity and complications of diabetes in the United States include heart disease and stroke, high blood pressure, blindness, kidney disease, nervous system disease, amputations, dental disease, complications of pregnancy, and other conditions related to biochemical imbalances, plus susceptibility to other illnesses. Mild to severe forms of nervous system damage affect 60 to 70% of those with diabetes.¹² Diabetic neuropathy is a complication of microvascular circulation impairment or smallvessel disease.^14,15 "The early age of onset of Type 2 diabetes in children may particularly increase the risk of microvascular complications, which are known to be directly related to duration of diabetes and hyperglycemia" (p 386).¹⁶ With impaired glucose control, diabetic peripheral neuropathy and varying degrees of sensory loss develop in 10 to 12 years. Diabetic foot ulcers may be a result of ill-fitting shoes, repetitive normal walking pressures (40–60 psi) or trauma from high pressure (600+ psi), such as stepping on a foreign object.¹⁴ Factors placing the diabetic neuropathic limb at risk for ulceration or lower extremity amputation are similar and involve those with type 1 and type 2 diabetes.¹⁷

The CDC's Diabetes Surveillance System reported a variety of data and trends involving the lower extremity. In 2002, hospital discharge rates per 1,000 diabetic population for neuropathy were approximately 6.5% for ages 0 to 44 years, 4% for ages 45 to 64 years, 3.5% for ages 65–74 years, and 3.5% for ages 75 years and older. Ulcer, as first listed diagnosis in the same population, increased with increasing age.¹⁸ In 2001, the crude age adjusted rate of hospital discharge for nontraumatic lower extremity amputations per 1,000 diabetic population in the United States was 6.5%.¹⁹ Based on 2000 to 2002 BRFSS data, approximately 11.8% of US adults with diabetes had a history of foot ulcers, significantly more prevalent among persons who were obese than among those who were not (p < 0.001).²⁰ Among other variables in a multivariate analyses, younger age, longer duration of disease, and obesity were all associated independently with a history of foot ulcer.²⁰ Diabetes is a leading cause of nontraumatic lower extremity amputation. It is believed that as many as half of these amputations could be prevented through effective foot care practices.²¹

MANAGEMENT GUIDELINES

Many publications exist pertaining to preventive foot care or management of ulceration related to the diabetic neuropathic limb. Publications range from review articles to clinical practice guidelines. Specifics of review are limited to off-loading techniques in the prevention or management of ulceration considering weight and youth in the person with diabetes and peripheral neuropathy.

Mayfield et al.,¹⁷ in a comprehensive technical review of preventive foot care, documented increased body mass as a cause of increased plantar pressure. The use of quantitative plantar pressure measurement has increased to customize footwear, but evidence to support the effectiveness or use over clinical examination is lacking. Properly fitted footwear was identified as a means of reducing abnormal pressures and protecting the foot, as was a custom molded insert. For those without ulceration but with increased plantar pressure, one management strategy was wearing an athletic shoe or walking shoe with cushioned soles or inserts, adequate toe box, and lace-up vamp.

The American Diabetes Association's (ADA)²² preventive foot care paper followed recommendations based on the evidence reviewed in Mayfield et al.¹⁷ and stated that increased plantar pressure may be adequately managed with well-cushioned walking shoes or athletic shoes.

Elftman,¹⁴ in an informative article on neuropathic limb management, discussed proper shoe wear and design, accommodative insoles, custom ankle-foot orthoses, and a variety of off-loading methods. Therapeutic footwear constructed of soft leather without seams and shaped to match the foot with a shock absorbing modifiable sole was suggested to reduce possible high-pressure points but was not recommended for ulcer management. The rocker sole aids in reducing forefoot pressure. Multidensity accommodative insoles compressible by half of the full thickness and constructed of closed-cell, self-molding material next to the foot are required for neuropathic foot protection. Custom ankle-foot orthoses casted semi-weightbearing are indicated to reduce plantar pressures in chronic deformities and when shoes, modifications, and insoles cannot reduce the occurrence of breakdown. Custom ankle-foot orthoses (AFOs) include total contact AFOs, neuropathic walkers, and axial-resist or patella tendon-bearing orthoses. Recommendations for offloading ulcerations with ankle-foot containment consisted of prefabricated ankle-foot orthoses, prefabricated walkers, posterior splint with an off-loading plantar insole, total-contact cast, and orthotic dynamic system splint. Specialized shoes used to off-load plantar surfaces consisted of Plastazote healing sandals, half shoes, wedged shoes, postoperative/cast shoes, and wound shoe systems.

The National Diabetes Education Program's²¹ guide for health professionals in the prevention of diabetes foot problems placed patients in two categories: low or high risk. High risk included patients with loss of protective sensation, absent pedal pulses, foot deformity, history of foot ulcer, or prior amputation. Management for high risk included assessment and prescription of appropriate footwear, among other directives. For active ulcer or foot infection, patients required weight relief before leaving the office and a prescription for therapeutic footwear to help modify weightbearing and protect the foot. General footwear directives consisted of proper fit and style of shoe, avoiding pointed toe and open toe shoes, high heels, thongs, and sandals. Shoes constructed of canvas, leather, suede, and other breathable materials or elastic were recommended. Footwear with laces, Velcro, or buckles allowing adjustment was suggested. Properly sized athletic or walking shoes were recommended for everyday wear and to accommodate deformity. Depth-inlay shoes or custom molded inserts may be needed for high-risk patients, depending on their deformity and ulcer history. A research review within the guide²¹ stated that localized stresses can be minimized by redistributing forces during walking with properly constructed and well-fitting shoes and inserts. Those with ulcer history should use special inserts and footwear.

Brem et al.²³ acknowledged the importance of off-loading diabetic neuropathic ulcers as part of a protocol for treatment. The authors supported total-contact casting (TCC) as a method of redistributing weight for ulcer treatment while recognizing TCC limitations.

Boulton et al.²⁴ provided a treatment plan algorithm that suggested using a removable device to eliminate pressure for ulcer management with clinically significant arterial disease or clinical signs of cellulitis or osteomyelitis. A total-contact cast was recommended to eliminate pressure in those without signs of cellulitis or osteomyelitis. The removable device considered is an instant total-contact cast.

Snyder and Lanier²⁵ discussed the necessity of off-loading difficult wounds and Charcot foot, providing a pictorial compendium. Alternatives to TCC included standard below-knee casts, Charcot restraint orthotic walker (CROW)/total-contact brace, prefabricated walker, the DH walker (Royce Medical, Camarillo, CA), the integrated prosthetic and orthotic system (IPOS, Niagara Falls, NY), Orthowedge (Darco International, Huntington, WV), healing sandal, reverse IPOS heel relief shoe system, L'Nard splint/multiboot (Alimed Inc., Dedham, MA), standard AFOs, patella tendon-bearing brace, prefabricated pneumatic walking brace, and Scotch boot (custom fibrocast boot). The authors commented that a disadvantage of CROW was the cumbersome nature relative to size and that the device may not be appropriate for the morbidly obese patient. Modalities for preventing recidivism were provided but not reviewed.

The ADA²⁶ consensus conference on diabetic foot wound care mentioned the following off-loading strategies: TCC, bed rest, bivalve and other casts/boots, surgical shoes, half-shoes, sandals, and felted foam dressings. The method used is based on clinician expertise. If healing does not occur, specialty referral is indicated.

The Wound, Ostomy, and Continence Nurses Society's²⁷ clinical practice guideline for professionals who work with adults who have lower-extremity neuropathic disease composed a table of off-loading techniques for management of wounds in this population. Each suggested method of offloading is listed with corresponding advantages and disadvantages as follows: bed rest, total-contact cast, walking splints/removable cast shoes, wedge-sole shoe, healing shoe with large toe box and customized inserts, adhesive felt pads, felted foam pads, rest pads (adjunct for hammer/claw toes), interdigital pads, lamb's wool, and padded socks. After review of articles, protocols, and practice guidelines, specific prevention or management strategies for patients with increased body mass were not addressed. Implications for children and adolescents were absent. Additional review of the scientific literature regarding this topic follows.

Spencer,²⁸ in a Cochrane Review to assess the effectiveness of pressure-relieving interventions in the prevention and treatment of diabetic foot ulcers, used a variety of search strategies to locate randomized controlled trials (RCT). Four prevention RCTs of pressure-relieving interventions and one treatment RCT were identified. Interventions for prevention supported the use of in-shoe orthotics, although differences in the clinical efficacy of products were unclear. Cushioning and pressure redistribution have similar benefit. Running shoes as a pressure-relieving intervention lack adequate evaluation. Removable casts (Scotchcast or Hope) or foam inlays were without RCT evaluation. The treatment RCT supported total-contact casting as an effective intervention but had limited evidence.

Praet and Louwerens,²⁹ in a study to determine the effect of shoe design on plantar pressure of patients with diabetic neuropathy during walking, tested three shoe designs. Subjects consisted of 10 female patients, 44 to 78 years of age, with known diabetes and without foot deformity or ulceration. Categories ranged from over-the-counter to custom rocker-bottom shoes. All had standardized custom insoles, except for one control. Results showed the rocker-bottom principle as the most effective way to off-load the forefoot. The authors recommended in-shoe pressure measurements to evaluate individual therapeutic shoe prescriptions.

Brown et al.³⁰ measured in-shoe plantar pressures in patients without deformity using a baseline shoe and three types of rocker soles to examine the effect of type of rocker sole on plantar pressure. Subjects were 40 healthy patients (20 men, 20 women; age range, 30–60 years) selected over 3 years. Results showed a significant reduction (p < 0.01) in peak pressures and pressure-time integral across the forefoot in three rockers: toe only, negative heel, and double. The authors concluded there is scientific support for prescription rocker soles for patients who need forefoot pressure reduction.

Sinacore³¹ studied the healing times of diabetic neuropathic plantar ulcers in the presence of fixed deformities using the ambulatory method of total-contact casting (TCC) (n = 21). Average healing time was 67 ± 29 days. All ulcers healed using TCC but varied in healing time based on location of ulceration and fixed deformity, having provider implications.

Birke et al.,³² in a retrospective analysis, compared the healing rate of forefoot ulcers in patients with diabetes treated using a total-contact cast with those treated using alternative offloading methods (n = 120). Subjects were consecutive patients with diabetes referred for treatment of new, nonsurgical forefoot ulceration. Healing time of forefoot ulcers was compared in those using an accommodative dressing, a healing shoe, and a walking splint versus a total-contact cast. Healing rates using alternative off-loading methods or a total-contact cast were comparable. The accommodative dressing compared with the healing shoe or the walking splint had a significantly lower healing time (p < 0.01). Recognizing the limited scientific review, the consideration of BMI as a variable is not apparent. Studies included adult subjects only.

EXPERT RECOMMENDATIONS

In an effort to describe best practice in protecting the diabetic neuropathic foot in overweight youth and obese adults, expert opinion was solicited from selected individuals practicing and recognized as experts in the field of prosthetics, orthotics and/or pedorthics. Ernesto Castro, CPed, Nancy Elftman, CO, CPed, Dennis Janisse, CPed, and Roger Marzano, LPO, LPed, responded to the following five questions:

1. What weight would you consider using materials different than usual practice to protect the foot from trauma during daily activities?

The range was 150 to greater than or equal to 300 pounds, with a mode and median of 250 pounds. Risk category and activity level were mentioned as contributing factors. For total insensitivity, using customary materials but replacing them more often was suggested. Also recommended was going above the ankle for stability and reducing forces in the foot with individuals weighing more than 300 pounds. Similarly, the weight limit for a therapeutic heel was approximately 300 pounds.

2. What orthotic materials specifically? Please combine or group as you would in total-contact orthoses.

Castro: 150 pounds: Single density Plastazote (P-1) or 18 share-A, Nora Lunamed (Freudenberg, Germany). Second layer, Poron (PORON Medical Urethanes, Woodstock, CT), PPT (Langer, Deep Port, NY), polyurethane at least 1/8-inch thick. Bottom layer material varies depending on the weight and activity level. Use ethylene vinyl acetate (EVA) base of 50 durometer with an additional thermoplastic material, Thermo-HK (UCO International, Wheeling, IL), for reinforcement that is only 1 mm thick after molding. > 180 pounds: Top and second layer as above. Use EVA base of 70 durometer with the same Thermo-HK for reinforcement. Never use thick plastics on an insensate foot.

Elftman: Vary Poron thickness for weight and activity level. The base or structure layer would be a higher durometer for the heavier patient. Three layers for the general population are Plastazote, Poron, polyethylene foam, or equal durometer.

Janisse: #1 Plastazote/polyurethane/cork or Plastazote/ polyurethane/cork.

Marzano: P-cell, Poron, and Puff (closed-cell urethane, Acor, Cleveland, OH) full length, then a firm EVA for posting and fill material to maintain the integrity of the orthoses and minimize deformation. On more active or heavier weight patients use EVA (Puff), Poron, thicker EVA for the full length body, with a firmer density EVA for posting and fill.

3. What brand of footwear and/or particular construction of footwear would you recommend?

Generally, it was agreed that the brand of footwear was less important than the construction and style. Professional staff select shoes to meet each patient's needs. In particular, the shoe shape needs to match the shape of the foot. Shoes with combination last and modifiable soles are necessary. Other important features are maximal depth, little to seamless uppers, opening for easy on and off, Velcro options, and good out-sole wear. One recommendation was shoes with long medial counters and polyurethane soles to provide longer wear, better support, and more contact with the ground. Another suggestion was using a neuropathic walker with an assistive device until balance is adjusted for patients greater than 300 pounds.

4. If ulceration, what form or type of off-loading in general? You may recommend based on which plantar aspect of the foot is involved, i.e., forefoot, midfoot, hindfoot.

Castro: Use a combination of rocker soles or bars and excavations (holes inside the shoes) making sure the hole is smooth with no rough or sharp edges. Special designed foot orthotic. Do not float the open ulcer when off-loading. Some pressure, even slight, keeps the bone underneath the ulcer from migrating out to fill the hole.

Elftman: Wound care shoe, splint, or neuropathic walker. CROW for chronic cases. Greater than 300 pounds use CROW. For ulcerations, an off-loading device must be worn for any weightbearing.

Janisse: Unload/relieve ulcers or prominences with posting on the bottom of the insert not on top next to the foot. Also, use Pquisc (a viscoelastic polymer; Rieckens, Evansville, IL) that can be mixed to any density for relief of prominences.

Marzano: If failed negative heel or other unloading temporary footwear, use walking boots with an incorporated custom foot orthosis regardless of the location of plantar lesion. Use a custom CROW orthosis if the patient has failed the cam walker, temporary healing shoe, or if the deformity precludes the use of an air cast boot. The comprehensive orthotic rehabilitation of the neuropathic ankle (CORONA) orthosis (Orthomerica Products, Inc., Orlando, FL) may be an option. If the patient is obese or has fluctuating lymphedema, use a custom CROW. Most forefoot and midfoot ulcerations respond well to air cast with a custom foot orthosis. Extensive midfoot and heel lesions respond best to a CROW. Patients that fail a CROW are placed in total-contact casting changed weekly. Use total-contact casting in children with plantar ulcerations because of compliance and size issues.

5. What is the recommended longevity or wearing time with customary daily use? Please include shoe and/or orthotic.

The time frame ranged from 3 months to 1 year for shoes and orthotics. Two experts suggested that shoes and orthotics be checked for breakdown and perhaps replaced every 3 to 6 months. Consistent with the Medicare therapeutic shoe benefit, one expert recommended three pairs of inserts for the shoes to last a year. Another addressed weight loss as a factor in needing new foot orthoses because feet get smaller quickly with weight loss. Also, depending on growth spurts, children's feet may change rapidly, requiring new shoes and foot orthoses. Footwear should be replaced when the upper or outsole begins to distort or lean.

CONCLUSION

Nationally, individuals classified as obese have a higher percentage of diabetic neuropathic ulcers than do those who are not obese. Younger age, longer duration of diabetes, and obesity were all independently associated with a history of foot ulcer. Ulcer management strategies for off-loading/unloading the ulcer are varied, and the scientific basis is limited. Best practice protocols and guidelines are needed for management or prevention of ulceration in the overweight population. Studies determining the clinical efficacy of practice decisions and patient outcomes are warranted. As Americans become heavier, the numbers of those with diagnoses of diabetes increase. This trend affects all age groups and has serious health care implications. With children currently developing type 2 diabetes at an early age coupled with poor glycemic control, teenagers will require appropriate, attractive therapeutic footwear to match an active lifestyle and allow for the overweight foot in the near future. If we are to reach national goals in decreasing foot ulcers and lower extremity amputations caused by diabetes, immediate action is needed in these special populations.

FUTURE RESEARCH

Based on current national data and trends, review of the literature, and expert opinion, the following research questions are offered for consideration:

1. What instruments or tools have validity in measuring plantar pressures for the overweight, obese, or morbidly obese?

2. What orthotic materials and manner of customization are clinically efficacious in the prevention of ulceration based on patient weight and activity level in the diabetic neuropathic foot?

3. What footwear is most appropriate for prevention of ulceration in the overweight, obese, or morbidly obese?

4. What casting techniques or variations are indicated in off-loading neuropathic ulcers in the morbidly obese?

5. What is the clinical efficacy of total-contact casting versus the neuropathic walker (CROW) in diabetic foot ulcer management for the obese or morbidly obese?

6. What future implications exist for shoe design and construction in preventing ulceration in the adolescent with diabetic peripheral neuropathy based on activity and weight?

Correspondence to: Kathy L. Cisney, MSN, APRN-BC, CWOCN, CPed, University of Kentucky Chandler Medical Center, Continuum of Care, 800 Rose Street, Room H-149, Lexington, KY 40536–0293; e-mail: .

KATHY L. CISNEY, MSN, APRN-BC, CWOCN, CPed, is Wound, Ostomy, and Continence Advanced Practice Nurse Specialist at the University of Kentucky Chandler Medical Center, Lexington, Kentucky.

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