Page th Annual Clinical Symposium on Advances in Skin and Wound Care Washington DC, Total Contact Cast: Is it Really the Gold Standard?

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1 26 th Annual Clinical Symposium on Advances in Skin and Wound Care Washington DC, 2011 James McGuire DPM, PT, CPed, FAPWCA Certified in Wound Care by the Council for Medical Education and Testing, CMET Total Contact Cast: Is it Really the Gold Standard? James McGuire DPM, PT, CPed, FAPWCA Director Leonard Abrams Center for Advanced Wound Healing Temple University, Philadelphia, PA Original Supporting Evidence Myerson M, Papa J, Eaton K, Wilson K. The total contact cast for management of neuropathic plantar ulceration of the foot. JBJS (Am) 1992;74: Helm PA, Walker SC, Pullium G. Total contact casting in diabetic patients with neuropathic foot ulcerations. Arch Phys Med Rehab 1984;65:69l-3. Pring DJ, Casiebanca N. Simple plantar ulcers treated by below-knee plaster and moulded double-rocker plaster shoe: A comparative study. Lepr Rev 1982;53: Pollard JP, LeQuesne LP. Method of healing diabetic forefoot ulcers. Br Med J 1983; 286: Joseph B, Joshua S, Fritschi EP. The moulded double-rocker plaster shoe in the field treatment of plantar ulcer. Lepr Rev 1983;54: Diamond JE, Sinacore DR, Mueller MJ. Moulded double-rocker plaster shoe for healing a diabetic plantar ulcer: A case report. Phys Ther 1987;67: Sinacore DR, Mueller MJ, Diamond JE, Blair VP, Drury D, Rose SJ. Diabetic plantar ulcers treated by total contact casting. Phys Ther 1987;67: Walker SC, Helm PA, Pullium G. Total contact casting and chronic diabetic neuropathic foot ulcerations: Healing rates by wound location. Arch Phys Med Rehabil 1987;68: Kaplan M, Gelber RH. Care of plantar ulcerations: Comparing applications, materials and non-casting. Lepr Rev 1988;59: Bossen F, Lethner F. Plantar casts in the management of advanced ischemic and neuropathic diabetic foot lesions. Diabet Med 1989;6: Birke JA, Novick A, Patout CA, Coleman WC. Healing rates of plantar ulcers in leprosy and diabetes. Lepr Rev 1992;63: Sinacore DR. Healing times of diabetic ulcers in the presence of fixed deformities of the foot using total contact casting. Foot Ankle Int 1998;19: Page 1

2 Sinacore DR. Total contact casting for diabetic neuropathic ulcers. Phys Ther 1996;76: A review of 13 published studies of total contact casting 0f 526 ulcers found that the ulcers had been present for 182 ± 14 days (mean ± SE), but 88% healed in an average of 43 ± 2 days. 11 of the 13 studies had mean healing times of days Total Contact Cast Still considered by many to be the gold standard for offloading because of improved healing rates (88.9%) and cost savings when compared to standard methods of care Results of 9 TCC Studies Average Healing Time: days Percent Healed: 88.9% Helm 1984; Sinacore 1987; Walker 1987; Mueller 1989; Meyerson 1992; Birke 1992; Lavery 1997; Armstrong 2001; Birke 2002 Slide Courtesy of Greg Bohn, MD Page 2

3 Spencer SA. Pressure relieving interventions for preventing and treating diabetic foot ulcers. Cochrane Database of Systematic Reviews 2000 There is limited evidence of the effectiveness of orthotic interventions over removal of callus. There is some evidence evaluating the relative effectiveness of two types orthotic devices. There is very limited evidence of the effectiveness of therapeutic shoes. Treatment There is very limited evidence of the effectiveness of total contact casts in the treatment of diabetic foot ulcers 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: The total contact cast (TCC) heals 90% of neuropathic foot ulcers by 12 weeks (average healing time of 6 weeks). Results of 9 TCC Studies Average Healing Time: days Percent Healed: 88.9% Helm 1984; Sinacore 1987; Walker 1987; Mueller 1989; Meyerson 1992; Birke 1992; Lavery 1997; Armstrong 2001; Birke 2002 Page 3

4 Comparison of Diabetic Wound Treatments Days to Healing % % % % 100% 90% 80% 70% 60% 50% 40% 30% 20% Percentage Healed 20 10% 0 Total Contact Cast Apligraf Dermagraft Regranex 0% Avg Days to Heal Percent Healed 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: Dermagraft - Marston, Hanft, et al; The efficacy and safety of Dermagraft, Diabetes Care 2003, 26: Regranex - Kantor, Margolis; Expected Healing Rates for Chronic Wounds, Wounds 2000, 12: Slide Courtesy of Dr Greg Bohn Use of Pressure Offloading Devices in Diabetic Foot Ulcers Do we practice what we preach? Wu SC, Jensen JL, Weber AK, DPM, Robinson DE, DPM, 3 and Armstrong DG. Diabetes Care November; 31(11): Of the 895 respondents who treat diabetic foot ulcers, shoe modifications (41.2%, P < 0.03) were the most common form of offloading 15.2% of the centers reported use of removable cast walkers Total contact casts were used by only 1.7% of the centers. Use of Pressure Offloading Devices in Diabetic Foot Ulcers Do we practice what we preach? 58.1% (520 centers) did not consider TCCs as the gold standard to offload the noninfected plantar diabetic foot 45.5% of the centers nationwide reported no use of TCCs Page 4

5 Use of Pressure Offloading Devices in Diabetic Foot Ulcers Do we practice what we preach? Reasons for Not using TCC s patient tolerance (55.3%) time needed to apply the cast (54.3%) cost of materials (31.6%) reimbursement issues (27.5%) familiarity with method of application (25%) customizing parts (20.9%) staffing/ordering supplies (15.2%) clinician coverage (10.6%). Off-loading the diabetic foot wound: A randomized clinical trial. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB., Diabetes Care Jun;24(6): Compared the effectiveness of total-contact casts (TCC), removable cast walkers (RCW), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe. Outcome and recurrence rate of diabetic foot ulcers treated by a total contact cast Matricali GA, Deroo K, Dereymaeker G., Foot Ankle Int Sep;24(9): Examined healing and final outcome after TCC 22-month period, 15 consecutive patients with a total of 17 ulcers started treatment with a TCC. Three ulcers were lost to follow-up (FU). Average FU was 91 weeks. TCC proved to be a very effective tool for healing neuropathic foot ulcers, but the recurrence rate and frequency of other complications remained very high. (8 out of 12) Difficult to achieve reliable (secondary) preventive general foot care, and to prescribe and manufacture reliable footwear. Page 5

6 Total Contact Casting of the Diabetic Foot in Daily Practice A prospective follow-up study Nabuurs-Franssen MH, et al. Diabetes Care February 2005 vol. 28 no consecutive patients casted and followed until healing; all had polyneuropathy, 44% had PAD, and 29% had infection (PEDIS grade2) 90% of all nonischemic ulcers without infection and 87% with infection healed in the cast (NS). New ulcers, all superfical, developed in 9% and preulcerative lesions in 28% of the patients while in the cast. All complication wounds healed within 13 days In patients with PAD but without critical limb ischemia, 69% of the ulcers without infection and 36% with infection healed (P < 0.01). Diabetic Peripheral Polyneuropathy The absence of two of five sensory modalities: Vibration sensation using the 128-Hz tuning fork Light touch Sharp-Dull discrimination Achilles tendon reflex Semmes Weinstein 10-g monofilament >2 sites tested Schaper NC: Diabetic foot ulcer classification system for research purposes: a progress report on criteria for including patients in research studies. Diabetes Metab Res Rev 20 (Suppl. 1):S90 S95, 2004 Critical Limb Ischemia Ankle pressure <50 mmhg Toe pressure <30 mmhg TcPo 2 < 30 mmhg) Moderate PAD absence of both pedal pulses and/or presence of intermittent claudication and/or ankle brachial index <0.9 and/or toe brachial index <0.6 and/or TcPo mmhg Page 6

7 Total Contact Casting of the Diabetic Foot in Daily Practice A prospective follow-up study Nabuurs-Franssen MH, et al. Diabetes Care February 2005 vol. 28 no Three total contact casting modalities were used: a nonremovable TCC, a removable TCC (RCC), and a shoemodel cast (SMC) that could not be removed by the patient. These casts were applied using a modification of the technique described by Kominsky (13), and the choice of cast was based on both patient and cast characteristics Cast Criteria Results pnp, presence of peripheral neuropathy, no signs of infection of PAD; inf, presence of infection, no signs of PAD; pad, presence of PAD, no signs of infection; inf + pad, presence of both infection and PAD Page 7

8 Fife CE, et al; Why is it so hard to do the right thing in wound care Wound Rep Reg : 18 p % DFU patients had Gold Standard TCC used Cost of care was half that of those that did not TCC is time consuming and poorly reimbursed Bilaminate skin reimbursed more generously 17% VLU patients received adequate compression Inadequate reimbursement Lack of familiarity with Clinical practice Guidelines Slide Courtesy Dr. Greg Bohn 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: Dermagraft - Marston, Hanft, et al; The efficacy and safety of Dermagraft, Diabetes Care 2003, 26: Regranex - Kantor, Margolis; Expected Healing Rates for Chronic Wounds, Wounds 2000, 12: TCC Systems Page 8

9 Revisiting the Total Contact Cast Maximizing off-loading by wound isolation Diabetes Care April 2005 vol. 28 no Petre M, Tokar P, Kostar D, Cavanagh PM This experiment suggests that the name total contact cast is somewhat of a misnomer. To optimize wound offloading, the cast should provide total contact everywhere except for the wound site, which should be mechanically isolated. The conventional TCC reduced peak pressures to 98 ± 30 kpa, The woundisolation TCC reduced peak pressures to 60 ± 16 kpa. Paired t tests found a reeduction in pressure by 39% (P = 0.008) and pressure-time integral by 25% (P = 0.012) compared with the conventional TCC. Kadakia, A R; Espinosa, N; Smerek, J; White, K; Myerson, M S; Jeng, C L (2008). Radiographic comparison of sagittal plane stability between cast and boots. Foot & Ankle International, 29(4): Sagittal plane motion was restricted significantly more with a fiberglass cast (8º) compared to the FP Foam Walker (16º), and XP Pneumatic Walker (15º), Donjoy Max Walker (19º), and the SP Walker (39º). Non-Removable Cast Walker Cable Tie System Page 9

10 PTB Orthoses Comparison of forefoot ulcer healing using alternative offloading methods in patients with diabetes mellitus. Birke JA, Pavich MA, Patout Jr CA, Horswell R., Adv Skin Wound Care Sep-Oct;15(5): patients with DM with new forefoot ulceration at the Louisiana State University Health Sciences Center Diabetes Foot Program After adding ulcer grade (1, 2, or 3) and width into the model, there was no difference between healing time comparing ACCOMMODATIVE DRESSING (P =.253), HEALING SHOE (P =.815), and WALKING SPLINT (P =.525) to the TCC. Forefoot ulcers were closed within 12 weeks in at least 81% of cases irrespective of the off-loading method. The healing rate of forefoot ulcerations in patients with diabetes using alternative off-loading methods or a TCC appeared to be comparable when the method was selected based on location of ulcer, patient age, and duration of ulceration. Foot pressures during gait: a comparison of techniques for reducing pressure points. Lawless MW, Reveal GT, Laughlin RT., Foot Ankle Int Jul;22(7): healthy, normal volunteer subjects were examined to determine the effectiveness of four modalities (fracture walker, fracture walker with insert, and open and closed toe total contact casts) in reducing plantar foot pressure All four treatment modalities significantly reduced (p < 0.05) plantar pressure at the first metatarsal head None of the methods proved to be superior Page 10

11 Pneumatic bracing and total contact casting have equivocal effects on plantar pressure relief. Hartsell HD, Fellner C, Saltzman CL., Foot Ankle Int Jun;22(6): Compared plantar pressures produced in healthy subjects wearing a Running Shoe(RS), Total Contact Cast (TCC) and 'customized' prefabricated Pneumatic Walking Brace (PWB) [Aircast ] Unloading of the forefoot was 63.72% for the TCC and 58.77% for the PWB, respectively Comparison of Offloading Treatments Lavery LA, Lavery DC, Vela SA, Quebedeaux TL: Reducing dynamic foot pressures in high risk diabetic subjects with foot ulcerations; A comparison of treatments. Diabetes Care. 19(8),August pp Prefabricated Aircast Pneumatic Walker vs Standardized Shoe and TCC kpa 1 st MPJ 3 rd MPJ 5 th MPJ 5 th MTB Heel Baunhauer JF, Wervey R, McWilliams J, Harris GF, Shereff MJ: A comparison study of plantar foot pressure in a standardized shoe, TCC, and prefabricated pneumatic walking brace. Foot and Ankle Int, 18(1) Jan pp26-33 Page 11

12 Removable Cast Walker vs. TCC N/cm² Pollo FE, Crenshaw MS, Brodsky MD, Kirksey BS: Plantar Pressures in Total Contact Casting Verses a Diabetic Walking Boot. Baylor University Medical Center, Dallas, TX. Accepted for presentation, Annual Meeting of the Orthopedic Research Society, San Francisco, Feb 25-28, 2001 Evaluation of Removable and Irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Armstrong DG, Lavery LA, Wu S, Boulton AJ. Diabetes Care, March RESEARCH DESIGN AND METHODS-- 50 patients randomly assigned to two groups: an RCW or a RCW wrapped with a cohesive bandage (Instant Total Contact Cast or itcc) Subjects were evaluated for 12 weeks or healing RESULTS--An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the itcc group than in the RCW group (82.6 vs. 51.9%, P = 0.02). Of the patients with ulcers that healed, those treated with an itcc healed significantly sooner (18.7 vs days, P = 0.02). Armstrong DG, Lavery LA, et al. Activity Patterns of Patients With Diabetic Foot Ulceration: Patients with active ulceration may not adhere to a standard pressure offloading regimen. Diabetes Care, Vol. 26, No. 9, September pts. Recorded total steps per day measured by a waist-worn computerized accelerometer vs. an RCW-mounted accelerometer 1,219 ± 821 steps taken per patient per day Only 28% of total daily activity was recorded wearing their RCW Only 30% of the patients recorded more steps on than off However those patients only wore the device a total of 60% of the total steps they took Page 12

13 A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcerations. Katz IA, Harlan A, Miranda-Palma B, Prieto- Sanchez L, et. al. Diabetes Care, March RESEARCH DESIGN AND METHODS--In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with neuropathic plantar foot ulcers were randomly assigned to one of two groups: an irremovable RCW (itcc) or a standard TCC. Primary outcome measures: ulcers healed at less than or equal to 12 weeks, healing rates, complication rates, cast placement/removal times, and costs. RESULTS-- Proportions of patients healed within 12 weeks in the itcc and TCC groups were 94 and 93%, respectively, when patients who were lost to follow-up were excluded. Healing rates were statistically equivalent in the two groups, as were complication rates The itcc took significantly less time to place and remove than the TCC. Also an overall lower cost associated with the use of the itcc compared with the TCC. An Off-the-Shelf Instant Contact Casting Device for the Management of Diabetic Foot Ulcers: A randomized prospective trial versus traditional fiberglass cast Diabetes Care March 2007 vol. 30 no Piaggesi A. et al. No statistical difference observed in healing rates between groups A (TCC) and B (DM Walker), (95 vs. 85%), healing time (6.5 ± 4.4 vs. 6.7 ± 3.4 weeks), and adverse events (6 vs 4) n=40 Group B, was 78% less expensive compared with group A (P < 0.001) Time required for application reduced by 77% and removal 58% compared to group A (P < 0.001) Patients satisfaction with the treatment was higher in group B (P < 0.01) Effectiveness of Removable Walker Cast Versus Nonremovable Fiberglass Off-Bearing Cast in the Healing of Diabetic Plantar Foot Ulcer A randomized controlled trial. Faglia E, et al. Diabetes Care July 2010 vol. 33 no diabetic patients with nonischemic, noninfected neuropathic plantar ulcers were randomly assigned for treatment with a total contact cast [TCC] group or walker cast (Stabil-D group). Ulcer surface decreased from 1.41 to 0.21 cm 2 (P < 0.001) in the TCC group and from 2.18 to 0.45 cm 2 (P < 0.001) in the Stabil-D group (P = 0.722). 73.9% in the TCC group and 72.7% in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 ± 3.1 and 39.7 ± 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708). Page 13

14 Stabil-D Orthosis Total Contact Cast Indications Plantar ulceration Wagner grade I and II, UTHSC grade A0, 1, 2, or 3 Neuropathic, pressure, traumatic Avoid: Arterial, Venous Neuropathic fracture (Charcot) Post-reconstructive surgery Sinacore DR: Total contact casting for diabetic neuropathic ulcers. Phys Ther. 1996;76: Total Contact Cast Contraindications Acute infection Fever Palpable lymph nodes Deep sinus tract or narrow deep wound Perfuse drainage Active dermatitis Excessive/Fluctuating edema Claustrophobia Known non-compliance Arterial insufficiency ABI <0.8 Wagner Grade III, IV, V None of these are absolute contraindications to the use of a removable cast walker Page 14

15 Total Contact Cast Stockinette, Foam, Light Dressing Total Contact Cast Felt Protectors Total Contact Cast Gypsona Plaster Base Page 15

16 Total Contact Cast Fiberglass Reinforcement Wound Isolation TCC M Petre, P Tokar, D Kostar, PR Cavanagh Diabetes Care 28: , 2005 Skive the Foam to Create a Cavity That is More Bowl-like than Cylindrical TCC Systems Page 16

17 15 Subjects Football Dressing for Neuropathic Forefoot Ulcerations Rader AJ, Barry T. Wounds 2006;18(4):85-91 Total weeks to complete epithelialization 3.8 ± 2.60 (range 1-10 weeks) Inexpensive, easy to apply Non-adherent contact layer covered by a silver alginate and a foam secondary dressing 3 rolls 4 cast padding, 1 roll 4 gauze, 1 roll 4 self adherent wrap Standard post op or cast shoe for ambulation Rader AJ, Barry TP.The football: an intuitive dressing for offloading neuropathic plantar forefoot ulcerations. Int Wound J Mar;5(1): Epub 2008 Jan 3. Forty-one consecutive subjects with 58 wounds were enrolled. Overall wound healing rates for University of Texas Health Science Center class 1A, 1B, 1C, 1D, 2A, 2B, 2C and 3B plantar forefoot ulcerations is 2.91 weeks with a 95% confidence interval of weeks for complete wound epithelialization. Football Dressing for Neuropathic Forefoot Ulcerations Rader AJ, Barry T. Wounds 2006;18(4):85-91 Page 17

18 Football Dressing for Neuropathic Forefoot Ulcerations Rader AJ, Barry T. Wounds 2006;18(4):85-91 Page 18