Healing Diabetic Foot Ulcers With a Rigid Total Contact Cast
Healing Diabetic Foot Ulcers With a Rigid Total Contact Cast
A total contact cast (TCC) is considered the gold standard for healing diabetic foot ulcers (DFU). Numerous studies have demonstrated the excellent healing success of a TCC; however, its adoption in routine clinical use does not match its success rate. This lack of implementation is due to several factors: Medicare's payment structure, lack of clinical training, and a variety of patient factors. These factors have reduced clinicians' use of TCC to approximately 25% of DFU. The aim of this review was to analyze and demonstrate common scenarios for outpatient wound centers where a TCC may be beneficial to both patients and hospital systems, and to expand its usage to more closely reflect its healing success rate.
The rising incidence and prevalence of diabetes in the United States has resulted in a synonymous escalation of nonhealing diabetic foot ulcers (DFU). Patients with these foot ulcers have flooded urgent care centers, primary care offices, podiatric services, inpatient wards, emergency rooms, and ultimately, wound care centers. Such occurrences have resulted in a boom of advance modalities to help heal these ulcers and prevent amputations. These modalities include bioengineered skin substitutes, platelet derived growth factors, negative pressure therapy, hyperbaric oxygen, advanced wound dressings, ultrasonic debridement tools, "superbug" busting antibiotics, and stem cell therapy.
The challenges in healing DFU have fostered the use of advanced modalities. Concerns with diminishing reimbursement in procedural services, by both providers and hospital systems struggling to fight disease and maintain financial viability, have promulgated the use of such expensive modalities. Studies supporting the healing potential of advanced modalities over standard saline moistened dressings have further created a tailspin of doctrine termed "standard of care" that advanced (as well as expensive) modalities are preferable to treat DFU that have failed to heal.
Furthermore, studies touting DFU healing rates with various modalities have used variable offloading tools that do not provide consistent optimal pressure relief. Ideal offloading is obtained through minimal pressure on the diabetic ulcer. To date, a rigid total contact cast (TCC) has demonstrated the lowest peak plantar pressure on an ambulatory patient (Figure 1).
(Enlarge Image)
Figure 1.
Peak plantar pressures on first metatarsal head.
A 2005 nationwide (United States) survey of 895 private practices treating DFU indicated that shoe modifications were used in 41.2% of cases for offloading, despite the lack of evidence supporting its use. Total contact casting was utilized in more than 40% of clinics; however, only 1.7% of the centers used the TCC as treatment for the majority of DFU in their care (Figure 2). If the TCC were used as standardized pressure relief in various clinical trials, then further validity could be given to the efficacy of bioengineered dressings, regenerative matrices, negative pressure therapies, and other advanced modalities.
(Enlarge Image)
Figure 2.
Offloading modalities.
Traditional DFU healing protocols include risk factor modification, offloading, debridement, and a protective dressing. A common failure in this pathway is the offloading method.
Sub-optimal offloading results in delayed healing and thus directs the clinician into considering more advanced, and oftentimes expensive, modalities. Current US health care guidelines are vague in ensuring that optimal offloading is provided to patients prior to failed healing. Healing failure, or wounds that have failed with "conservative" care after 30 days, are then considered appropriate for receiving care with advanced modalities. Biomedical companies have further marketed this intersection between stalled healing and product qualification use. As a result, there has been an unprecedented rise in the cost of healing wounds without a reciprocal return on investment. A recent study reported that the cost of healing a wound using TCC was half the cost of treating a wound without using TCC ($11,946 vs. $22,494).
Numerous published studies and clinical workshops over the last few decades have demonstrated the superiority of a TCC system in healing DFU. Peer-reviewed studies have shown average healing of 80%–90% within 6 weeks for DFU. The healing success of the TCC is reduced in practice to approximately 25% of DFU due to lack of reimbursement, noncompliance, active infection, high grade ulceration, and mobility/fall risk limitations. Advanced modalities, such as skin substitutes or growth factors, have, at best, demonstrated a 56% healing rate within 12 weeks (Figure 3). Such products may also pose similar exclusions as a TCC for meeting application criteria.
(Enlarge Image)
Figure 3.
Diabetic foot ulcer healing rates of various modalities.
A meta analysis-derived parabolic healing velocity curve also substantiates the healing rate using a traditional casting system versus sharp debridement and bioengineered products. The wound velocity of the TCC shows a steep rate of change in healing in the first few weeks compared to other modalities (Figure 4). This rate of change is equivalent to rapid acceleration and shorter healing times with the TCC. An endpoint of 35 days, or 5 weeks, was established due to the nearly 90% probability of wound closure. Based on these alarming differences, it would seem that a TCC would be a first line of defense in healing DFU. The bottom line is that DFU heal faster with a TCC.
(Enlarge Image)
Figure 4.
Healing velocity for various modalities.
Although a vast number of clinicians have employed the TCC in their practices, there are several factors that discourage the industry from uniformly adopting the TCC. One key factor stems from clinics and physicians concerned with payment bundling. Claim denials are often a result of using debridement codes or skin substitute codes (eg, Apligraf, Dermagraft, Oasis) along with TCC application. This is in direct conflict with the American Medical Association's position that TCC is a separate and distinct procedure. Such denials have created significant controversy between providing the gold standard for offloading and receiving reimbursement for patient care.
A smaller portion of insufficient use is due to lack of trained clinicians who are able to apply a TCC.
The aforementioned phenomenon has piqued this author's interest in thoroughly analyzing the protocol/pathway driven model for healing DFU, and how it relates to facilities' and clinicians' financial motivations in choosing a particular route for healing DFU.
The approach for managing a DFU at a wound center is shown in Figure 5. Pressure relieving options in an ambulatory patient include: diabetic shoes, modified pressure relieving shoes, foam/felt footwear, Charcot Rigid Orthotic Walkers (CROW) boots, modified removable casts, cam walkers, and TCC.
(Enlarge Image)
Figure 5.
Managing a diabetic foot ulcer at a wound center.
Figure 6 shows the current recommended pathway for optimal offloading and the application of TCC.
(Enlarge Image)
Figure 6.
Current recommended pathway for optimal offloading and TCC application.
In the past, approximately 25% of all patients with diabetes qualified for a TCC at initial presentation to the clinic, as indicated in this model. The clinics viewed qualified candidates as patients with a DFU who: 1) are not infected; 2) have adequate arterial flow; 3) do not have significant edema or pain; 4) have gait stability; 5) have no automobile driving issues, or any patient safety hazards/compliance issues; 6) have Wagner 1 or 2 ulcers.
Additional patients can be reconsidered for TCC after other interventions have been completed, such as infection control or vascular surgery. The TCC will reduce edema, so those patients can be casted, with the first cast change in 2–3 days to maintain adequate fitting. To address stability, a cane or walker could be added, which allows these patients to be casted. Finally, the patient needs to enlist family, friends, and community resources to help them through the treatment process, and to maximize their ability to heal. It is much easier to enlist help for a few weeks, rather than decades after losing a limb.
Abstract and Introduction
Abstract
A total contact cast (TCC) is considered the gold standard for healing diabetic foot ulcers (DFU). Numerous studies have demonstrated the excellent healing success of a TCC; however, its adoption in routine clinical use does not match its success rate. This lack of implementation is due to several factors: Medicare's payment structure, lack of clinical training, and a variety of patient factors. These factors have reduced clinicians' use of TCC to approximately 25% of DFU. The aim of this review was to analyze and demonstrate common scenarios for outpatient wound centers where a TCC may be beneficial to both patients and hospital systems, and to expand its usage to more closely reflect its healing success rate.
Introduction
The rising incidence and prevalence of diabetes in the United States has resulted in a synonymous escalation of nonhealing diabetic foot ulcers (DFU). Patients with these foot ulcers have flooded urgent care centers, primary care offices, podiatric services, inpatient wards, emergency rooms, and ultimately, wound care centers. Such occurrences have resulted in a boom of advance modalities to help heal these ulcers and prevent amputations. These modalities include bioengineered skin substitutes, platelet derived growth factors, negative pressure therapy, hyperbaric oxygen, advanced wound dressings, ultrasonic debridement tools, "superbug" busting antibiotics, and stem cell therapy.
The challenges in healing DFU have fostered the use of advanced modalities. Concerns with diminishing reimbursement in procedural services, by both providers and hospital systems struggling to fight disease and maintain financial viability, have promulgated the use of such expensive modalities. Studies supporting the healing potential of advanced modalities over standard saline moistened dressings have further created a tailspin of doctrine termed "standard of care" that advanced (as well as expensive) modalities are preferable to treat DFU that have failed to heal.
Furthermore, studies touting DFU healing rates with various modalities have used variable offloading tools that do not provide consistent optimal pressure relief. Ideal offloading is obtained through minimal pressure on the diabetic ulcer. To date, a rigid total contact cast (TCC) has demonstrated the lowest peak plantar pressure on an ambulatory patient (Figure 1).
(Enlarge Image)
Figure 1.
Peak plantar pressures on first metatarsal head.
A 2005 nationwide (United States) survey of 895 private practices treating DFU indicated that shoe modifications were used in 41.2% of cases for offloading, despite the lack of evidence supporting its use. Total contact casting was utilized in more than 40% of clinics; however, only 1.7% of the centers used the TCC as treatment for the majority of DFU in their care (Figure 2). If the TCC were used as standardized pressure relief in various clinical trials, then further validity could be given to the efficacy of bioengineered dressings, regenerative matrices, negative pressure therapies, and other advanced modalities.
(Enlarge Image)
Figure 2.
Offloading modalities.
Traditional DFU healing protocols include risk factor modification, offloading, debridement, and a protective dressing. A common failure in this pathway is the offloading method.
Sub-optimal offloading results in delayed healing and thus directs the clinician into considering more advanced, and oftentimes expensive, modalities. Current US health care guidelines are vague in ensuring that optimal offloading is provided to patients prior to failed healing. Healing failure, or wounds that have failed with "conservative" care after 30 days, are then considered appropriate for receiving care with advanced modalities. Biomedical companies have further marketed this intersection between stalled healing and product qualification use. As a result, there has been an unprecedented rise in the cost of healing wounds without a reciprocal return on investment. A recent study reported that the cost of healing a wound using TCC was half the cost of treating a wound without using TCC ($11,946 vs. $22,494).
Numerous published studies and clinical workshops over the last few decades have demonstrated the superiority of a TCC system in healing DFU. Peer-reviewed studies have shown average healing of 80%–90% within 6 weeks for DFU. The healing success of the TCC is reduced in practice to approximately 25% of DFU due to lack of reimbursement, noncompliance, active infection, high grade ulceration, and mobility/fall risk limitations. Advanced modalities, such as skin substitutes or growth factors, have, at best, demonstrated a 56% healing rate within 12 weeks (Figure 3). Such products may also pose similar exclusions as a TCC for meeting application criteria.
(Enlarge Image)
Figure 3.
Diabetic foot ulcer healing rates of various modalities.
A meta analysis-derived parabolic healing velocity curve also substantiates the healing rate using a traditional casting system versus sharp debridement and bioengineered products. The wound velocity of the TCC shows a steep rate of change in healing in the first few weeks compared to other modalities (Figure 4). This rate of change is equivalent to rapid acceleration and shorter healing times with the TCC. An endpoint of 35 days, or 5 weeks, was established due to the nearly 90% probability of wound closure. Based on these alarming differences, it would seem that a TCC would be a first line of defense in healing DFU. The bottom line is that DFU heal faster with a TCC.
(Enlarge Image)
Figure 4.
Healing velocity for various modalities.
Although a vast number of clinicians have employed the TCC in their practices, there are several factors that discourage the industry from uniformly adopting the TCC. One key factor stems from clinics and physicians concerned with payment bundling. Claim denials are often a result of using debridement codes or skin substitute codes (eg, Apligraf, Dermagraft, Oasis) along with TCC application. This is in direct conflict with the American Medical Association's position that TCC is a separate and distinct procedure. Such denials have created significant controversy between providing the gold standard for offloading and receiving reimbursement for patient care.
A smaller portion of insufficient use is due to lack of trained clinicians who are able to apply a TCC.
The aforementioned phenomenon has piqued this author's interest in thoroughly analyzing the protocol/pathway driven model for healing DFU, and how it relates to facilities' and clinicians' financial motivations in choosing a particular route for healing DFU.
Healing Pathway
The approach for managing a DFU at a wound center is shown in Figure 5. Pressure relieving options in an ambulatory patient include: diabetic shoes, modified pressure relieving shoes, foam/felt footwear, Charcot Rigid Orthotic Walkers (CROW) boots, modified removable casts, cam walkers, and TCC.
(Enlarge Image)
Figure 5.
Managing a diabetic foot ulcer at a wound center.
Figure 6 shows the current recommended pathway for optimal offloading and the application of TCC.
(Enlarge Image)
Figure 6.
Current recommended pathway for optimal offloading and TCC application.
In the past, approximately 25% of all patients with diabetes qualified for a TCC at initial presentation to the clinic, as indicated in this model. The clinics viewed qualified candidates as patients with a DFU who: 1) are not infected; 2) have adequate arterial flow; 3) do not have significant edema or pain; 4) have gait stability; 5) have no automobile driving issues, or any patient safety hazards/compliance issues; 6) have Wagner 1 or 2 ulcers.
Additional patients can be reconsidered for TCC after other interventions have been completed, such as infection control or vascular surgery. The TCC will reduce edema, so those patients can be casted, with the first cast change in 2–3 days to maintain adequate fitting. To address stability, a cane or walker could be added, which allows these patients to be casted. Finally, the patient needs to enlist family, friends, and community resources to help them through the treatment process, and to maximize their ability to heal. It is much easier to enlist help for a few weeks, rather than decades after losing a limb.
