Total Contact Casting and Neuropathic Foot Wounds: Implementing a Gold Standard and Overcoming Barriers to Clinical Use

  Neuropathic foot ulcers affect up to 15% of diabetic patients and are the leading cause of hospitalization and lower extremity amputation among this patient population.^1,2 Among the diabetic population, amputation is associated with re-amputation, contralateral limb amputation, placement in extended care facility, decrease in quality of life and death.^3-7 The combination of sensory neuropathy and high plantar pressures is the main factor responsible for the development and maintenance of plantar foot ulcers in patients with diabetes mellitus.⁸

  Ulcer healing requires adequate blood supply, control of infection, appropriate wound care, debridement and off-loading. Off-loading has been proven to interrupt the pathogenesis of ulcer development and maintenance as well as lead to positive histologic wound changes.⁹ Other studies have documented the beneficial role of pressure reduction on the healing of neuropathic ulcerations.^10-11 The ideal off-loading device reduces plantar pressures while ensuring patient compliance.

Mechanism of Action of TCC

  The TCC is effective in treating diabetic foot ulcers due to redistribution of plantar pressure over a large surface area, decreased shear stress, reduction of edema, enforced compliance and protection.^12-15 Multiple studies have demonstrated decreased plantar pressures with TCCs with pressure reduction at the site of ulceration ranging from 64-92%.^16-22 Additionally, it has been shown that patients voluntarily reduce their activity level, taking fewer steps daily, while wearing a TCC.¹¹

TCC the Gold Standard

  TCCs have been listed by numerous sources as the gold standard for the treatment of diabetic neuropathic foot ulcerations and the beneficial effects of total contact cast have been documented in multiple prospective^19,27,32 and retrospective studies.^{15,19,26,32,33} Consistently high incidence of wound healing, ranging from 73-100%, has been reported with TCC treatment.^{10,11,15,19,23-31}

  Several randomized clinical trials in which the TCC was compared with other off-loading modalities demonstrated the effectiveness of the TCC for treatment of neuropathic foot ulcers.^10,11,34 Specifically, a randomized prospective trial by Armstrong et al showed plantar ulcers treated with TCC had a significantly higher healing rate (89.5%) than ulcers treated with removable cast walkers (65%) or half-shoes (58.3%) and significantly fewer days to healing at 33.5 days for TCC compared to 50.4 days for RCW and 61.0 days for the half-shoes.¹¹ Additionally, patients were shown to be significantly less active in the TCC. A Level I study by Mueller et al comparing TCC to TCC with Achilles tendon lengthening reported 88% of ulcers in the control TCC group healed after a mean of 44 days.³⁴ A prospective randomized trial conducted by van de Weg et al showed median time for diabetic foot ulcerations to heal was significantly shorter using a TCC (52 days) versus custom footwear (90 days).³⁵

  In addition to beneficial clinical effects, TCCs have been shown to have beneficial effects on wound histology. Pressure reduction with total contact casting results in changes in the histopathologic features of neuropathic foot ulcers with a shift from a predominance of inflammatory elements to a reparative pattern consisting of cutaneous annexes, capillaries and granulation tissue.⁹

  Patient compliance with off-loading strategies is generally poor due to the lack of symptoms secondary to sensory neuropathy. Activity monitoring has shown that the majority of patients wear prescribed removable off-loading devices for only 28% of their daily steps.³⁶ Functional advantages of the TCC include maintaining ambulatory lifestyle during the healing period. Additionally, patients have been shown to take fewer steps while wearing the TCC further increasing the off-loading effect.¹¹

Lack of Use by Clinicians

  Despite the well-documented success of the TCC, few clinicians use this modality as part of their diabetic foot ulcer treatment regimen. A recent study reported that less than 2% of 895 practitioners that treat diabetic foot ulcers use TCCs for the treatment of plantar foot wounds.³⁷ Several attributes of TCC have been cited as deterrents to their use despite clinical evidence of their effectiveness: cost, patient tolerance, time for cast removal and application, reimbursement issues, familiarity with method of cast application, customizing parts, staffing/ordering supplies, inability to frequently monitor wounds, and risk of iatrogenic cast complications.^37-38

  Many clinicians avoid TCC use due to concern of iatrogenic cast complications. In a recent study evaluating a series of 398 TCCs, 22 (6%) new ulcerations occurred secondary to cast treatment. The majority of these ulcerations healed during the remainder of the TCC treatment and the rate of permanent sequelae from cast-related injury was 0.25%.³⁹ A second study examining the safety of TCC in patients with neuropathic foot ulcers reported a total of 14 (17%) complications (majority skin irritation) in 82 consecutive casts, none requiring alteration in the treatment protocol.⁴⁰ Both studies concluded that the TCC can be safely used in patients with neuropathic ulcers but minor complications should be anticipated. Ensuring the foot is at 90 degrees, applying two casts in first week of use to maintain fit and re-casting all loose or wet casts can minimize complications. Although reimbursement is listed as a concern, TCC has been reimbursed by Medicare under HCPCS code 29445 for years with additional supply reimbursement.

  Patient tolerance is another factor leading to decreased use of the TCC. A study examining quality of life among patients receiving different off-loading modalities to heal diabetic foot ulcerations showed that quality of life was more impacted by whether or not the wound healed quickly than how the ulceration was treated. Given the high percentage of wounds healed and fast healing rates seen with the TCC, this modality may cause the least detrimental effect on quality of life in patients suffering from diabetic foot ulcers.

  The need for training and expertise in cast application and removal is another factor listed as a deterrent in use of TCCs. A study by Nabuurs-Franssen et al showed that 76% of diabetic foot ulcers healed in a median of 33 days with a complication rate of 9% new ulcers and 29% pre-ulcerative lesions (all which resolved in the TCC prior to healing of the primary foot ulcer).⁴² Data in this study included the learning curve of the staff in cast application and learning curve of multiple different cast technicians over the course of the study. This can be addressed by using a standardized technique.

  There are several absolute and relative contraindications to TCC use including deep infection, poor skin quality, severe arterial insufficiency, poor patient compliance, extensive wound drainage, fluid shifts, blindness, and postural instability.⁴³ In regard to both ischemia and infection, Nabuurs-Franssen et al showed that ulcers with moderate ischemia or infection can be treated effectively with TCC.⁴² In this study, 76% of ulcers, including those with superficial infection or moderate ischemia, healed in a median of 33 days.⁴² In regard to postural instability, Lavery et al showed sway was significantly greater with TCCs with a heel compared but that this increase in sway can be eliminated by using a TCC with cast boot.⁴⁴

TCC-EZ

  Recently, improvements have been made that overcome many of the disadvantages of the standard TCC. The TCC-EZ (MedEfficiency; Wheat Ridge, Colorado) consists of a synthetic mesh cast supported by an outer shell that provides additional support and stability for weight bearing. This device provides comparable off-loading to standard TCCs while significantly decreasing the time of cast application. A study by Jensen et al. comparing plantar foot pressure in standard TCC to the TCC-EZ showed lower average and maximum pressures in all areas of the foot except the rear foot in the TCC-EZ.⁴⁵ Fewer layers has lead to reduction in application and removal times for the TCC-EZ (75s) compared to standard TCC (452s).⁴⁶ The TCC-EZ is also technically easier to apply than standard TCC requiring less training and decreasing potential for iatrogenic wounds and other cast complications. Additionally, the TCC-EZ design decreases cast weight and improves patient postural stability.

How Systems Can Overcome Some of the Barriers to Using TCC

  Wu et al report additional factors affecting TCC usage include customizing parts as well as staffing/ordering supplies.³⁷ Piaggesi et al report that although the TCC is a safe and effective treatment modality it is rarely pursued as a treatment option for many factors including the need for “many different materials to be assembled in a complex way.”⁹ Preassembled total contact cast systems have the ability to overcome these barriers decreasing cast application time as well as staff time required for supply ordering and assembly.

Conclusion

  Evidence-based medicine demonstrates that the TCC is the best treatment modality to off-load diabetic foot ulcerations. Recent advancement in TCC technology is making it quicker and easier to implement this gold standard as first line therapy in a busy clinic setting.

  Kristine Hoffman, DPM is a third year resident at the North Colorado Podiatric Surgical Residency in Greeley, Colorado.

  Jeffrey Jensen, DPM practices in Denver, CO with the Diabetic Foot & Wound Center at Rose Medical Center. He is the Research and Externship Director at the North Colorado Podiatric Surgical Residency program in Greeley, CO. He is also the founder of MedEfficiency, Inc.

  Eric D. Jaakola, DPM practices in Denver, CO with the Diabetic Foot & Wound Center at Rose Medical Center. He is the Education Chair at the North Colorado Podiatric Surgical Residency program in Greeley, CO.

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  For an exclusive article by Peggy Dotson, RN, BS, owner of Healthcare Reimbursement Strategy Consulting, on Reimbursement for Total Contact Casting visit www.todayswoundclinic.com-TCC-Reimbursement.