The Great Debate: Offloading Diabetic Foot Ulcers: TCC vs. CAM Walkers Gregory A Bohn, MD MAPWCA, ABPM/UHMS Department of Surgery Central Michigan School of Medicine Tawas, Michigan
Disclosures Medical/Scientific Boards: Medline Convatec Acelity ULURU Consultant: ULURU Activities: President American Board of Wound Healing Past President: Association for the Advancement of Wound Care (AAWC)
Diabetes 135 million Diabetics worldwide United States 20.8 million Diabetics (7% of population) 1.5 million new cases yearly 25% diabetics develop foot ulcer during their lifetime 50% or more of amputations occur in diabetics
Diabetes Fact: 85% of all diabetes-related lower extremity amputations are preceded by a diabetic foot ulceration.
5 year Mortality Rate in Diabetics after amputation: 5 year Mortality Rate after amputation: Neuropathic : 45% Ischemic : 55% Moulik PK, Mtonga R, Gill GV, Amputation and Mortality in New-Onset Diabetic Foot Ulcers Stratified by Etiology. Diabetes Care February 2003 vol. 26 no. 2 491-494
Roll On Traditional Cast Hybrid Models
Data Thru 11/15/07 26 Healed Patients Avg Weight = 196# High = 285# Low = 88# Avg Healing Time = 41 Days High = 118 days Low = 6 days Avg # Casts = 7.2 TCC-EZ Outcome Data: Jeffrey Jensen, DPM Diabetic Foot & Wound Center, Denver, CO
Results of 9 TCC Studies Average Healing Time: 43.73 days Percent Healed: 88.9% Helm 1984; Sinacore 1987; Walker 1987; Mueller 1989; Meyerson 1992; Birke 1992; Lavery 1997; Armstrong 2001; Birke 2002
Total Contact Cast: Indications Patient must be non-infected. Adequate blood supply to heal ABI 0.8 Wagner classifications Grade 1 and 2 go can go into TCC s and be managed effectively on an out-patient basis. Good complement to HBO Wounds that probe to tendon, capsule or bone, or with abscesses do not go into TCC s!
TCC Patient Selection Plantar Diabetic & Neuropathic Foot Ulcerations Wagner Grade 1-2 Diminishes the vertical & shearing forces of walking, allowing a plantar/lateral lesion to heal Non-Infected with Reasonable Vascular Status Charcot Neuroarthropathy Fractures Eliminates the stresses of weight bearing, allowing the condition to consolidate Post-operative management To immobilize the surgical site to allow healing by minimizing the weight-bearing & shear forces
Total Contact Cast Contraindications Acute Infection Severe Ischemia Claustrophobia Wagner Grade 3,4 Non-Compliance Allergy to casting material Excessive or fluctuating edema Excessive drainage
TCC Functional Attributes Allows for healing while ambulating Forced Compliance Immobilization, total contact with forefoot, arch, heel, Achilles tendon, and cone of lower leg. No pistoning Ankle locked at 90%. Eliminates the propulsive phase of gait Shortens stride length Minimizes vertical (Ground Reactive Pressures) and shear stresses Protects affected limb from trauma
Total Contact Cast The device has been shown to decrease plantar pressures to nearly imperceptible levels of 0.34 n/cm2. The near complete elimination of motion in the TCC also substantially curtails shearing forces. - Todd, WF; Ostomy & Wound Management, August, 1995
How does the cast offload? Cast offloads by transferring weight bearing to the leg itself (Load Sharing) Total contact weight bearing on plantar surface (Load Redistribution) Shaw, J.E., et al., The mechanism of plantar unloading in total contact casts: implications for design and clinical use. Foot Ankle Int, 1997. 18(12): p. 809-17.
F-Scan Pressure Measurement Tekscan Measurement System
F-Scan Pressure Measurements Tekscan Measurement System on 10 Healthy Normal Pts Location/Cast Type Traditional TCC Hybrid Cast System Full Plantar Surface Pressure Forefoot Pressure Mid-foot Pressure Avg 8.4 psi Max 50.3 psi Avg 8.5 psi Max 48.3 psi Avg 6.2 psi Max 23.9 psi Rear-foot Pressure Avg 10.8 psi Max 40.5 psi Avg 7.2 psi Max 49.9 psi Avg 7.1 psi Max 47.2 psi Avg 5.6 psi Max 12.6 psi Avg 9.3 psi Max 48.8 psi
Days to Healing Percentage Healed Advanced Therapies Comparison of Diabetic Wound Treatments 160 140 120 100 80 60 40 88.9% 44 56.0% 84 84 30.0% 140 50.0% 100% 90% 80% 70% 60% 50% 40% 30% 20% 20 10% 0 Total Contact Cast Apligraf Dermagraft Regranex Avg Days to Heal Percent Healed 0% TCC - Average Outcomes of Studies by Helm 1984; Meyerson 1992; Walker 1987; Birke 1992; Sinacore 1987; Lavery 1997; Armstrong 2001; Mueller 1989; Birke 2002 Apligraf - Veves, Falanga, et al; Graftskin, a Human Skin Equivalent, Diabetes Care 2001, 24:290-295. Dermagraft - Marston, Hanft, et al; The efficacy and safety of Dermagraft, Diabetes Care 2003, 26:1701-05. Regranex - Kantor, Margolis; Expected Healing Rates for Chronic Wounds, Wounds 2000, 12:155-158
Off-Loading the Diabetic Foot Wound Armstrong, et al Diabetes Care, June 2001 100% 90% 80% 89.5% 50.4 61.0 70 60 70% 50 60% 50% 40% 30% 33.5 65.0% 58.3% 40 30 20 Percent Healed Mean Days to Healing 20% 10% 10 0% Total Contact Cast Removable Cast Walker Half Shoe 0
Healing/Days to Heal TCC vs itcc vs RCW 100 90 80 70 60 50 40 30 20 10 0 89.5 82.6 58 41.6 51.9 33 TCC itcc RCW Healing Rate Days to Heal Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes Care. 2005;28(3):551 554.
Implementation Of Contact Cast in a Multi Physician Clinic Contact Cast is Gold Standard for Offloading Physician Barriers Too time consuming 20 mins Not in my training Not worth the time Clinic Barriers Complex application Nursing not familiar with casting
Implementation Strategy Physician Education via Webinar Conference Call Nursing in serviced to apply dressing, stockinet, felt padding, protective sleeve Physicians applied the fiberglass cast sleeve
Wound Volume TCC Impact on Healing 0.025 Case 1 Clinical Course 0.02 0.015 Cast/Powder 0.01 0.005 0 Cast/Powder Healed 1 2 3 4 5 6 Weeks in Care
Wound Volume TCC Impact on Healing 0.14 0.12 0.1 0.08 0.06 0.04 0.02 0 Case 2 Clinical Course Cast/Powder Cast/Powder Healed 1 2 3 Weeks in Care
Volume Reduction TCC Impact on Healing 0.6 Weeks to Heal 0.5 0.4 0.3 0.2 Series1 Series2 Series3 Series4 Series5 Series6 0.1 0 1 2 3 4 Weeks to Heal
Wound Volume Compliance with Therapy Case 3 Clinical Course 0.6 Cast/Powder 0.5 0.4 0.3 0.2 Cast/Powder 0.1 Healed 0 1 2 3 4 5 6 7 Weeks in Care
Contact Casting and Days to Heal Days to heal dropped from 41 days to 15.2 days Physicians accept contact casting as best offloading for Diabetic Foot Wounds
Minutes Learning Curve Time per Application 6 5 4 3 2 1 0 1 2 3 4 5 6 7 8 9 10 Cast Application
Product Trial Cast application Felt and Foam Nursing Time 5.5 26.25 Nursing Cost $1.86 $22.00 Material cost $96.60 $6.58 Total Cost $98.46 $28.58 Reimbursement $146.00 $0.00 Net Difference $47.54 -$28.58 Total impact $76.12
Cost Impact on Clinic $160.00 $140.00 $120.00 $100.00 $80.00 $60.00 $40.00 $20.00 $0.00 -$20.00 -$40.00 Cost Impact Nursing Cost Material cost Total Cost Reimbursement Net Difference Contact Cast Felt and Foam
Cost Impact for Physicians and Clinics CPT 29445 : Application of rigid total contact leg cast Reimbursement National Ave $110.00 CPT 29445 Clinic Code links to APC 0426 National Ave Reimbursement $148.00
Hybrid Casting Systems addresses barriers to utilizing the TCC as a Gold Standard Easy to use Little or no learning curve Shortened application time Not messy Lighter Cooler Increased patient acceptance Functionality of traditional TCC
TCC Comparision to RCW Patients treated with a removable device wore the device for a total of 28% of their daily activity 2 Most compliant population not exceeding 60% 2 TCC significantly decreases the amount of ambulation and activity of the patient. This reduces the number of cycles of repetitive stress on the open ulceration. 1 1. Armstrong, D.G., et al., Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care, 2001. 24(6): p. 1019-22. 2. Armstrong, D.G., et al., 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): p. 2595-7.
Benefits Of TCC vs RCW Reduces and treats edema 1 Reduces risk of infection 1 Forced Compliance 2 TCC heals higher percentage of wounds in shorter time 6 1. Mueller, M.J., et al., Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial [see comments]. Diabetes Care, 1989. 12(6): p. 384-8. 2. Armstrong, D.G., et al., Off-Loading the Diabetic Foot Wound: a Randomized Clinical Trial. Diabetes Care, 2001. 24(6): p. 1019-1022. 3. Lavery, L.A., et al., Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations. A comparison of treatments. Diabetes Care, 1996. 19(8): p. 818-21. 4. Pollo, F.E., et al., Plantar pressures in fiberglass total contact casts vs. a new diabetic walking boot. Foot Ankle Int, 2003. 24(1): p. 45-9. 5. Baumhauer, J.F., et al., A comparison study of plantar foot pressure in a standardized shoe, total contact cast, and prefabricated pneumatic walking brace. Foot Ankle Int, 1997. 18(1): p. 26-33. 6. Armstrong, D.G., et al., Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care, 2001. 24(6): p. 1019-22.
Compression safe to use Compression safe in treating Diabetics with Ulcers Compression 18-25 mmhg controlled edema No reduction in ABI, TBI or SPP Mild compression can safely and effectively be used in Patients with Diabetes and edema. Wu SC, et al; Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks. Diabetes Res Clin Pract 2017 May;127:35-43 Liden B Total Contact Cast System to Heal Diabetic Foot Ulcers Surg Tech International 2017 Jul 25;30:71-76.
Contact Casting Complications TCC iatrogenic complications Complication rates have ranged from 11% to 30% of high risk patients, though the vast majority of these complications are minor. Most of the reported major complications are due to previously undiagnosed osteomyelitis and patient noncompliance. Most common are minor complications are dermal abrasions. Wukich and Motko found that 93% (13/14) of their complications were minor pressure ulcers and did not require a change in the treatment protocol. Wukich, D.K. and J. Motko, Safety of total contact casting in high-risk patients with neuropathic foot ulcers. Foot Ankle Int, 2004. 25(8): p. 556-60.
Other complications include: Maceration Fungal infection Claustrophobic-like response to the cast Cast being too tight Difficulty ambulating The most important factor for decreasing the risk of iatrogenic compilations is frequent cast changing. Wukich, D.K. and J. Motko, Safety of total contact casting in high-risk patients with neuropathic foot ulcers. Foot Ankle Int, 2004. 25(8): p. 556-60.
Available Hybrid Contact Cast Systems
Thanks for your attention
Complications of Casting Major complications: Dermal abrasions Stage 1 Did not require change in treatment Wukich, D.K. and J. Motko, Safety of total contact casting in high-risk patients with neuropathic foot ulcers. Foot Ankle Int, 2004. 25(8): p. 556-60.