Given the potential recurrence and complications with diabetic wounds, this author emphasizes the importance of adapting one’s offloading strategy as the wound progresses to healing. Accordingly, he discusses keys to assessing the biomechanical risks of patients with diabetic foot ulcers and offers insights from the literature on effective offloading modalities.
Offloading devices redistribute plantar pressures and reduce the shock and shear forces that contribute to tissue breakdown and interfere with the normal healing process of open plantar ulcers on the diabetic foot.1,2 The timely application of offloading devices to reduce pressure on pedal wounds and alter a patient’s gait to prevent injury or re-injury of the tissues requires the use of several types of devices and footwear during the course of healing.
The concept of “transitional offloading” first surfaced in 2010.3 The term describes the process of applying different offloading devices at different times during the phases of wound healing to prevent injury to the healing plantar surface based on the available data on the efficacy of various devices. It is the clinician’s job not only to heal the wound but also to protect delicate, recently healed tissues from further breakdown during the wound maturation process.
In 2006, I developed the “6 W” approach to help practitioners better assess biomechanical risk to the foot and choose appropriate offloading interventions from total contact casts to shoes.2 The 6Ws include: who the patient is; what the patient wears; when the patient walks; where the patient walks; why the patient walks; and the “way” the patient walks.
1. Who the patient is. Consider the patient’s intrinsic anatomical and physiological characteristics.
2. What the patient wears. Review the patient’s choice of footwear.
3. When the patient walks. Determine the amount of time or segment of the day spent standing or walking.
4. Where the patient walks. Inquire about the choice of surfaces and activities where the patient walks.
5. Why the patient walks. Consider the adherence and motivation of
6. The “way” the patient walks. Identify the specific gait characteristics of the patient.
This approach includes the intrinsic component of the patient’s inherent biomechanics, the extent of the effects of diabetes on the foot, the degree of neuropathy and the patient’s basic physiologic status. Also included in the assessment are the patient’s specific footwear choices, the temporal issues associated with walking, walking surfaces, the conditions the foot experiences, the motivational issues associated with ambulation and activity, and the specific gait patterns the patient exhibits.
Each of the above variables are part of a grid and get a relative numerical weight to determine the “6W Biomechanical Risk Assessment” score for that patient.3 The higher the relative score, the greater the risk of tissue damage and the more aggressive the approach to offloading must be (see the table “Assessing The Biomechanical Risk Of Patients” at right).
Normal tissue healing progresses in an orderly transition from one phase to another, and involves specific cell types, growth factors and various signaling molecules. Since the transition produces a wound that is very different in each of its stages, it is reasonable to assume these changes would require the use of various transitional offloading devices. Most wound care practitioners generally neglect the concept of using different offloading devices during the different phases of healing. These practitioners often compromise what they know is best practice and attempt to heal most wounds with a single offloading device during the entire healing process.
The clinician’s understanding of the component causes of wound development determines the various therapies that will manage the diabetic wound.4 Each contributing factor plays a role in the development of the neuropathic foot wound. The most predominant factor in wound development is neuropathy. The density of that neuropathy and the extent of involvement can be quite variable, but neuropathy is almost always a major component cause of the diabetic wound.5
Lavery and colleagues looked at patterns of these contributing factors and found that a combination of neuropathy, deformity, secondary callus formation and elevated peak pressure was the most common pathway to the development of a diabetic foot ulcer.6 Studies have implicated high pressures as a cause of ulceration but it has been difficult to pinpoint a specific threshold pressure that could predict the risk of ulceration.7,8 The origin of high pressures is usually the result of inherent biomechanical deformities that are often ignored as major contributing factors in the development of a wound.9 Muscle atrophy and connective tissue glycosylation alter the degree of these deformities and reduce flexibility of the foot, increasing forefoot pressures and tissue irritations in gait and shoe wear.10
Digital deformities such as hammertoes, mallet toes and contracted toes become fixed. The resultant digital irritations increase from shoe or bone-to-bone contact, which cause increased pressure and shear to the skin.11 Loss of toe function leads to increased direct plantar pressures and skin shear, and capsular stiffness decreases the digits’ ability to absorb pressures from footwear. Loss of flexibility in the Achilles tendon and the posterior muscle group also contributes to increased forefoot pressures in gait.12,13
Autonomic neuropathy reduces the ability of the skin to resist injury and infection.14 Dry skin cracks easily and is more vulnerable to bacterial and fungal invasion. Calluses form quickly and increased pressure on the dermal and subcutaneous tissues lead to intradermal and subdermal hemorrhage with fluid accumulation between and below tissue layers. Without early detection, callus debridement, timely drainage and offloading, these innocent appearing calluses and areas of intradermal hemorrhage or maceration can become limb-threatening problems. In the ideal situation, one should design offloading to prevent the development of ulcerations. All too often, we do not take offloading seriously until the foot has already ulcerated.
Research has implicated footwear as the precipitating cause of digital ulcers and as a significant contributor to wounds elsewhere on the foot.15 On the other hand, research has not shown shoes to be an independent predictor of wounding without accompanying foot deformity although properly prescribed and used therapeutic footwear can reduce the incidence of foot ulceration.16
Temporal concerns include the demands of one’s job or daily ambulatory activities such as daily trips to the store or exercise sessions. Part of the offloading prescription must address counseling the patient on analyzing and reducing the time spent on the foot during each day. Simply changing the patient’s routine can have a significant effect on reducing the accumulation of component causes due to unorganized activity.
In addition to how much time patients spend on their feet, the surfaces they walk on can greatly increase the stresses on the foot. Angled, uneven surfaces increase shear forces and increase the risk of ulceration. Constant use of stairs or rapid starts and stops play a significant role in increasing foot loading. One must address repetitive activities such as driving with a clutch or using pedal operated machinery when attempting to alter a patient’s biomechanical environment.
Understanding why the patient engages in various ambulatory activities while trying to heal has proven to be a poorly understood and ineffectively managed key component in the offloading process. The patient’s motivation to adhere to the clinician’s recovery plan will impact the success of treatment and outcomes more than any single variable.
Until the patient makes that decision, all our efforts will ultimately fail no matter how forcefully or expertly we employ them. When patients understand why their clinician wants them to follow a certain treatment plan and what the consequences are if they deviate from that plan, they are more apt to cooperate and enter into a relationship of trust and adherence to the suggestions.17
Healthcare practitioners have a tendency to expect patients simply to adhere and follow a doctor’s orders. Krasner and co-workers call this a “provider-centered” and not a “patient-centered” approach to care. Effective patient management must always involve a patient’s caregivers, family and friends, and not attempt to deal with patients as isolated disease entities.18 To quote Sibbald and colleagues, “It is important to treat the whole patient and not just the hole in the patient.”19
The way patients walk, including speed, stride and step length, is the last factor in finishing the biomechanical risk assessment of the foot. Gait patterns evolve over time and are often destructive in the presence of poor biomechanics and inappropriate footwear. In personal gait assessments, I have found that reducing the speed of gait, improving balance through training and flexibility exercises, and helping the patient develop a more apropulsive gait pattern significantly reduce the amount of plantar pressure that develops during the propulsive phase of gait. The problem with gait training is not that it is an ineffective means of reducing pressure. It is that good ambulatory behaviors extinguish rather rapidly without constant reinforcement from clinicians or physical therapists.
Once the 6W Biomechanical Risk Assessment is complete, you can more effectively prescribe the myriad of offloading devices for the diabetic foot. One can group offloading interventions into: those appropriate for the open foot wound; those used to transition the foot from the initial offloading to the patient’s final footwear; and the shoes, inner soles and braces used for everyday ambulation.
The total contact cast (TCC) has for many years been the gold standard for offloading a diabetic foot wound with healing rates as high as 90 percent.20-22 Despite this, the International Working Group on the Diabetic Foot and several studies have concluded that relatively few practitioners use this modality on a routine basis.23,24 There are many reasons for this that include: entrenched practice habits, fears and prejudices about the TCC; inadequate training; bad experiences with the device; and financial and reimbursement issues.
Based on strict criteria for the use of the TCC, a number of patients should not receive casting. They include patients with documented peripheral arterial disease, an ankle brachial index of less than 0.7 or an active infection.25 Other contraindications include cast claustrophobia, known non-adherence, fluctuating leg edema, active skin disease, a sinus tract with deep extension into the foot, or when the clinical staff has inadequate training and confidence to administer the treatment.
In numerous conversations with clinicians, I believe the single most common reason for the aforementioned hesitancy to use TCC is a documented lack of adherence in patients with diabetic neuropathic wounds. It is very difficult to trust patients with a demonstrated history of poor judgments with regard to their care with the responsibility of wearing and adhering to the restrictions imposed by the TCC. In those cases, one can and should use other treatment modalities.
Due to the aforementioned complications and the time and complexity of application and the cost of materials for the device, most practitioners treating diabetic wounds employ a number of alternative devices.1,2,26 These devices include: the removable cast walker (RCW); the non-removable cast walker or instant TCC (iTCC); the molded or double upright ankle foot orthosis (AFO) with or without a patellar tendon-bearing addition; Charcot restraint orthotic walkers (CROWs); a modified Carville healing sandal or shoe; the felted foam technique; or the football dressing. Other options are commercial offloading shoes, such as the half or wedge shoes, a postoperative shoe, and depth or custom-molded footwear.
Most practitioners choose from among these devices based on their individual experience with a particular modality, clinical availability, patient preference or even insurance reimbursement.2,27 The most commonly employed device is the surgical shoe with or without internal shoe modifications despite relatively poor evidence for healing in comparison to the TCC or the iTCC. For this reason, I have chosen to limit the shoe-based devices to the transition period between healing and final footwear. In addition to the TCC, the iTCC, football dressing and felted foam techniques have been the only methods that have consistently produced healing rates in the high 80 percent range and that one can reasonably expect to effectively offload and heal wounds within a 12-week period.28-31
If the clinician is not comfortable with the application of the TCC or if the patient has one or more of the established contraindications to its use, research has shown prefabricated removable cast walkers (RCWs) and non-removable cast walkers or the iTCC to be comparable to the TCC in their ability to offload the diabetic foot and close wounds in a similar timeframe.28,29 Armstrong and colleagues have been the pioneers in the use of the iTCC. Lavery, Pollo and Lawless have studied pressure redistribution in commercially produced removable walkers for patients with diabetes and found them to be comparable to the TCC and superior to other offloading devices in their ability to reduce pressure on specific areas of the foot.32-34
The key to healing with any of the offloading devices is the clinician’s ability to improve patient adherence by making it impossible to remove the devices without his or her approval. Knowles and Boulton found that when patients got specialized footwear free of charge, only 20 percent of the patients actually wore the shoes.35 Armstrong and co-workers found that when patients had the ability to remove offloading devices, they only wore RCWs 28 percent of the time during activities of daily living.36
We can make removable walkers non-removable by wrapping the devices with cast material or Coban, or by applying a simple cable tie connector to prevent patients from taking off the devices.1,2 There are also certain dressing techniques that can protect the foot with a non-removable dressing housed within the RCW, thereby allowing the patient to remove the RCW before sleeping. Researchers have demonstrated the effectiveness of felted foam and football dressings in helping to heal diabetic foot wounds.29-31,37
Non-removable devices, whether they are TCCs or non-removable dressings housed in an RCW or a surgical shoe, have been able to improve healing rates and the clinician’s ability to close wounds within the 12-week standard window.29-31,37 Removable devices allow easy access to the wound at any time during the healing process, making it easier to apply advanced wound products in the manner they were designed to be employed. Unfortunately, this removability may also tempt the patient to remove the devices for comfort.38 A number of RCWs are made of patellar tendon-bearing uppers or calf attachments in an effort to remove more weight from the foot. These RCWs are available as custom or prefabricated devices. They may have a slight edge over a standard RCW in their ability to offload the foot but clinical trials have yet to prove this.
In my hands, I have found non-removable devices very effective when they are new and the Velcro uppers have yet to stretch out. Once this happens or the clamshell upper loosens from edema reduction in the leg, the devices are no better than a standard walker.
For many years, trained practitioners have used felted foam dressings. One would apply 1/4-inch adhesive felt directly to the foot around the ulcer to reduce pressure on areas of ulceration. Then have the patient use a modified surgical shoe or prefabricated walker during ambulation. Clinicians can change the dressings and apply advanced wound treatments, leaving the protective pads in place. Reapply the pads weekly or biweekly until the wound heals.
Birke and colleagues compared felted foam dressings with a TCC, healing shoe and a walking splint with regard to healing times for forefoot ulcers.31 The authors found that 93 percent of the ulcers treated with the felted foam dressings healed within 12 weeks (mean time to healing of 20.9 days) in comparison to 92 percent (31.7 days) in those treated with the TCC.31
There has been increased use of the football dressing developed by Rader as data increases to support its use.30 One can use the dressing for patients in whom a TCC is contraindicated or when one cannot obtain a cast walker because of insurance limitations or other circumstances.30 The football dressing uses several layers of cast padding, secured with woven gauze roll bandage, additional padding, additional gauze and a layer of self-adherent wrap to finish the dressing and keep it in place. One can substitute a ¾-inch polyurethane foam layer against the foot or add this layer to the cast padding to augment its cushioning effect.
I have used the football dressing successfully in numerous cases in conjunction with RCWs by fitting the dressing into an existing cast walker to increase its effectiveness. These dressings, although they are non-removable, alleviate the feeling of claustrophobia some patients experience when they using a non-removable device such as the TCC.
Once the wound heals, it is the natural tendency for both the clinician and the patient to desire a return to the pre-ulcer footwear. The patient and the clinician both suffer from treatment fatigue after 12 to 20 weeks of seeing each other and the patient wants to get back to “normal” as soon as possible. Although both partners seek this separation, they must remain together for three to four more weeks while the plantar skin matures and its tensile strength increases. Fragile, recently epithelialized scar tissue in the area of a wound cannot hold up to the stresses of normal activity in the patient’s own footwear.
Steed and co-workers found that 69 percent of wounds recurred within 30 months after closure with a growth factor.39 Matricali and colleagues saw similar results in a study of the TCC, finding that 67 percent of the patients had developed recurrent ulcers after 22 months of follow-up.41 The patient’s previous footwear was a major contributor to the development of the original ulcer and one should not expect different results if one uses the same footwear again. Total contact molded innersoles in gait restrictive footwear such as a surgical shoe with a rocker sole and prefabricated diabetic healing shoes are the preferred next step. These shoes come with moldable inner soles, removable pressure reducing pixels or segments of the innersole that one can pull out from under areas of high pressure to increase protection of the plantar surface from pressure.
The choice of the patient’s final footwear must be a collaborative effort between patients and their physician or pedorthist. All podiatric physicians as well as many allopathic and osteopathic physicians have received specialized training in the use of depth footwear in the prevention and treatment of diabetic wounds. Apart from this additional training, I do not recommend that the treating physician simply write a prescription for diabetic footwear and think the job is done.
According to the Medicare Therapeutic Shoe Bill, the prescribing physician is responsible for ensuring the shoes and insoles or orthoses prescribed are appropriate in both fit and function to address the mechanical needs of the patient. It is far better to refer this responsibility to a licensed podiatrist or pedorthist, who has much more training in writing and/or filling a footwear prescription that is appropriate for the patient’s specific condition.41 Depth shoes come in many shapes and sizes, and patients must have guidance in the choices they make if they are to do what is best to prevent the development or recurrence of a diabetic foot wound.
The majority of patients, after a first or even second ulceration, will try to return to their pre-ulcer shoe size and style. They will be convinced that they will be able to manage their situation and prevent the problem from coming back again. They are quite wrong and you should not give in to their assurances and fail to insist that they get the right shoe and insert combination. The very least you should do is send them out with the proper prescription or referral. Better yet, you should see that they receive regular podiatric foot care visits and follow-up visits at their physician’s office to continually reinforce proper maintenance of blood sugar levels, diet and exercise routines.
Due to the digital deformities associated with the neuropathic foot, a standard depth shoe is not an option for patients. This does not mean their footwear has to have no style or that anatomically shaped, custom-molded shoes are appropriate for all patients with diabetes. Prior to the development of an ulceration, most patients with diabetes and no or low risk factors can wear their standard footwear. Patients with a 6W risk of 0 to 3 fall into this category. Once an ulcer has developed and healed, even patients with relatively minor foot deformities and low levels of risk should have protection from future ulceration with a total contact-molded innersole and depth shoes to accommodate it.
One should treat flexible correctable foot imbalances with a corrective functional device to reduce the digital and forefoot compensations caused by biomechanical imbalances. Rigid fixed deformities should have accommodation and areas of high pressure and shear specifically addressed with relief areas in the insole or soft inserts at the site of ulceration. Add rocker soles to the shoes when there is a real risk of repeat ulcers in the forefoot and when the patient has enough balance to master ambulation with them. Clinicians can use toe-only rockers for distal digital ulcers or metatarsal rockers to address metatarsal head lesions. One can add heel rollers or a cushion insert known as a solid ankle cushion heel (SACH) style heel to smooth out heel strike and prevent foot slap at heel contact, making it easier for the patient to adjust to the rocker platform. A double rocker sole can provide additional pressure relief for patients who present with a rocker bottom or Charcot foot.
The importance of total contact molded insoles cannot be over-emphasized and has been a staple of diabetic foot management since Brandt championed them in 1983.42 Simple, flat insoles or thin, dynamically molded materials are just not adequate to offload the diabetic foot or reduce the sliding in the shoe that produces shear.
I do fault a large number of pedorthists and podiatrists who dispense insoles for patients with diabetes either without molding them at all or settling with a simple heat gun aimed into the shoe for a few seconds in order to save time in the construction and dispensing of the shoe. The insoles must be thick enough to take up the room in the shoe necessary to give the patient a snug fit and fill the midfoot arches for proper pressure redistribution. However, the insole should not over-tighten the shoe or crowd the toes. In other words, it should reflect the professionalism and care of the dispensing physician or pedorthist, and not just be something anyone could do.
As is the case with custom-made CROW devices or other braces such as patellar tendon-bearing AFOs, custom-molded shoes are just too expensive to use in the absence of severe deformity that one absolutely cannot accommodate with available commercial last shoes, or marked structural weakness that requires the protection of a rigid brace.
Treating the patient with diabetes is complicated and often frustrating. Patience, persistence and a commitment to “do the right thing” are required from each clinician involved in their treatment.43 It is human to fail to adhere or cooperate, and it is equally human to fatigue and give up in the face of difficulty. We simply must rise to the call to be superhuman in this instance if we are to gain some ground on these diabetic wounds and put an end to the devastating ultimate complication of amputation.
Dr. McGuire is an Associate Professor of Podiatric Medicine and Orthopedics at the Temple University School of Podiatric Medicine. He is the Director of Temple University’s Leonard S. Abrams Center for Advanced Wound Healing.
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16. Uccioli L, Faglia E, Monticone G, et al. Manufactured shoes in the prevention of diabetic foot ulcers. Diabetes Care. 1995; 18(10):1376-8.
17. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005; 353(5):487-97.
18. Krasner DL. The Interprofessional Wound Caring Model. In: Krasner DL, Rodeheaver GT, Sibbald RG, eds. Chronic Wound Care: A Clinical Sourcebook for Healthcare Professionals, fourth edition. HMP Communications, Malvern, PA, 2007.
19. Sibbald RG, Williamson D, Orsted HL, et al. Preparing the wound bed-debridement, bacterial balance, and moisture balance. Ostomy Wound Manage 2000; 46(11):14-37.
20. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001; 24(6):1019-22.
21. Caravaggi C, Faglia E, De Giglio R, et al. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000; 23(12):1746-51.
22. Sinacore DR. Total contact casting for diabetic neuropathic ulcers. Phys Ther. 1996; 76(3):296-301.
23. Apelqvist J, Bakker K, Van Houtum WH, Nabuurs-Franssen MH, Schaper NC, eds. International Working Group on the Diabetic Foot. International Consensus on the Diabetic Foot. Maastricht, the Netherlands: International Working Group on the Diabetic Foot; 1999.
24. Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach? Diabetes Care. 2008; 31(11):2118-9.
25. Nabuurs-Franssen MH, Sleegers R, Huijberts MS, et al. Total contact casting of the diabetic foot in daily practice: a prospective follow-up study. Diabetes Care. 2005; 28(2):243-7.
26. Rathur HM, Boulton AJ. Pathogenesis of foot ulcers and the need for offloading. Horm Metab Res. 2005; 37(Suppl 1):61-8
27. Snyder RJ, Lanier KK. Off-loading difficult wounds and conditions in the diabetic patient. Ostomy Wound Manage. 2002; 48(1):22-35.
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31. Birke JA, Pavich MA, Patout CA Jr, Horswell R. Comparison of forefoot ulcer healing using alternative off-loading methods in patients with diabetes mellitus. Adv Skin Wound Care. 2002; 15(5):210-5.
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33. Pollo FE, Brodsky JW, Crenshaw SJ, Kirksey C. Plantar pressures in fiberglass total contact casts vs. a new diabetic walking boot. Foot Ankle Int. 2003; 24(1):45-9.
34. Lawless MW, Reveal GT, Laughlin RT. Foot pressures during gait: a comparison of techniques for reducing pressure points. Foot Ankle Int. 2001; 22(7):594-7.
35. Knowles EA, Boulton AJ. Do people with diabetes wear their prescribed footwear? Diabet Med. 1996; 13(12):1064-8.
36. Armstrong DG, Lavery LA, Kimbriel HR, Nixon BP, Boulton AJ. Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diabetes Care. 2003; 26(9):2595-7.
37. Katz IA, Harlan A, Miranda-Palma B, et al. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care. 2005; 28(3):555-9.
38. Armstrong DG, Boulton AJ. Pressure offloading and “advanced” wound healing: isn’t it finally time for an arranged marriage? Int J Low Extremity Wounds. 2004; 3(4):184-7.
39. Steed DL, Edington HD, Webster MW. Recurrence rate of diabetic neurotrophic foot ulcers healed using topical application of growth factors released from platelets. Wound Repair Regen. 1996; 4(2):230-3.
40. Matricali GA, Deroo K, Dereymaeker G. Outcome and recurrence rate of diabetic foot ulcers treated by a total contact cast: short-term follow-up. Foot Ankle Int. 2003; 24(9):680-4.
41. The “Medicare Benefit Policy Manual,” Publication 100-2, Chapter 15, Section 140 – “Therapeutic Shoes for Individuals with Diabetes” (Rev. 1, 10-01-03). Available at http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf  . Published June 8, 2012. Accessed Aug. 7, 2012.
42. Brand PW. The diabetic foot. In: Ellenberg M, Rifkin H (eds.) Diabetes Mellitus. Medical Examination Publishing, Garden City, N.Y., 1983, pp. 829-49.
43. Fife CE, Carter MJ, and Walker D. Why is it so hard to do the right thing in wound care. Wound Repair Regen. 2010; 18(2):154-158.
For further reading, see “A Guide To Offloading The Diabetic Foot” in the September 2005 issue of Podiatry Today, “A Guide To Preventative Offloading Of Diabetic Foot Ulcers” in the December 2011 issue, “Key Insights On Offloading Diabetic Neuropathic Ulcers” in the July 2009 issue or the DPM Blog “Back To Basics: How To Ensure Effective Offloading With Total Contact Casting” at http://tinyurl.com/bwwbjo8  .