Total Contact Casting is a Gold Standard of
Care for treating Neuropathic Arthropathy

Total Contact Casting is a Gold Standard of Care
Total contact casting (TCC) has been well documented in the literature as the 'gold standard' to remove weight off the injured foot to other areas of the leg (redistribution). TCC is a medically recognized procedure and is incorporated in several clinical guidelines.

Total Contact Casting Provides Predictive Patient Outcomes
Multiple randomized controlled trials (RCT) or clinical studies have been conducted which illustrate that the majority of diabetic foot ulcers heal with the offloading provided by TCC in a mean time of 35-52 days for 85-95% of patients. This compares to the standard care approaches with a mean time to heal of 50-90 days for only 21-65% of patients. In addition, multiple prospective and retrospective cohort studies also demonstrate the effectiveness of TCC. (See Summary of Clinical Evidence for TCC)

According to the American Diabetic Association1, eight percent of the population has diabetes and over 23% for those are age 60 or older. Fifteen percent will develop a foot wound in their lifetime. Sixty to seventy percent of diabetics have nerve damage which allows them to continue to traumatize their injured foot. Sixty percent of non-traumatic amputations are for diabetic patients.

Total Contact Casting is Cost Effective and Should be Used as First Line Therapy
Healing a diabetic foot ulcer quickly helps to avoid complications and the risk of amputation, while saving significant health care dollars. TCC and debridement when required, is a cost-effective treatment approach. Dr. Caroline Fife reviewed a database of 108,000 patient visits in 26 wound centers across 16 states2 and found significant cost savings when TCC is part of the treatment. Her 2009 data showed a cost savings of $10,000 per patient with the application of TCC. The average total treatment cost for diabetic foot ulcers including debridement and application of TCC was $11,946 per patient versus an average total treatment cost without TCC of $22,494 per patient. The non-TCC patients received advanced wound treatment such as negative pressure wound therapy and other advanced wound products without better outcomes.

Treatment Guidelines - Total Contact Casting

American Diabetes Association: Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care, June 2000, 23:873-874
American College of Foot & Ankle Surgeons (ACFAS), Diabetic Foot Disorders-A Clinical Practice Guideline, Sept/Oct 2006, Journal of Foot & Ankle Surgery
International Consensus on Diabetic Foot, 1999, International Consensus and practical guidelines on the management and prevention of the diabetic foot, Apelqvist J. et al.
International Working Group on Diabetic Foot
Multiple Wound Management Companies Guidelines

1 National Diabetes Fact Sheet 2007, American Diabetes Association
2 Intellicure™ Research Consortium (IRC) Analysis of TCC, Presented at Symposium on Advanced Wound Care, April 28, 2009, C. Fife.

Summary of Clinical Evidence for TCC

Randomized Controlled Trials

Reference	Off-Loading Modality	Mean Healing Time	Type of Study	Percent Healed	Type of Wound
Off-Loading the Diabetic Foot Wound Armstrong, DG Diabetes Care, 2001	TCC RCW Half-shoe	34 days 50 days 61 days	RCT 12 weeks	90% 65% 58%	UT 1A
Effects of Achilles Tendon Lengthening on Neuropathic Plantar Ulcers Mueller, MJ J Bone Joint Surg Am, 2003	TCC TCC & Achilles Tendon Lengthening	41 days 58 days	RCT	88% 100%	Neuropathic Plantar Ulcers
A Randomized Trial of Two Irremovable Off-Loading Devices in the Management of Plantar Neuropathic Diabetic Foot Ulcers. Katz, IA. Diabetes Care, 2005	TCC iTCC	35 days 28 days	RCT 12 weeks	93% 94%	Wagner 1, 2
An Off-the-Shelf Instant Contact Casting Device for the management of Diabetic Foot Ulcers Piaggesi, A Diabetes Care, 2007	TCC Optima Diab Walker	45 days 47 days	RCT 12 weeks	95% 85%	UT 1A/2A
Wound Healing: Total Contact Cast vs. Custom-Made Temporary Footwear for Patients with Diabetic Foot Ulceration Van De Weg, FB Prosthetics & Orthotics Int, 2008	TCC Custom Footwear	52 days 90 days	RCT 16 weeks		Wagner 1, 2
Total Contact Casting in Treatment of Diabetic Plantar Ulcers Mueller, MJ Diabetes Care, 1989	TCC Traditional Dressing	42 days 65 days	RCT	90% 32%	UT 1A/2A
Effectiveness and Safety of a Non-Removable Fiberglass Off-Bearing Cast vs. a Therapeutic Shoe in the Treatment of Neuropathic Foot Ulcers Caravaggi, C Diabetes Care, 2000	TCC Cloth Shoe		RCT 30 days	50% 21%	Neuropathic Plantar Ulcers
Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wounds Armstrong, DG Diabetes Care, 2005	iTCC RCW	42 days 58 days	RCT 12 weeks	83% 52%	UT 1A

Prospective Cohort Studies

Reference	Off-Loading Modality	Mean Healing Time	Type of Study	Percent Healed	Type of Wound
Comparison of Forefoot Ulcer Healing Using Alternative Off-Loading Methods in Patients with Diabetes Mellitus Birke, JA Adv Skin Wound Care, 2002	TCC Padded Dressing Healing Shoe Walking Splint	48 days 36days 42 days 51 days	Prospective Cohort 12 weeks	92% 93% 81% 83%	Wagner 1, 2, 3
Total Contact Casting of the Diabetic Foot in Daily Practice Nabuurs-Franseen, MH Diabetes Care, 2005	Polyneuropathy Non-Ischemic No Infections Polyneuropathy Non-Ischemic With Infection PAD Non-Ischemic No Infections PAD Non-Ischemic With Infection		Prospective Cohort 12 weeks	90% 87% 69% 36%

Retrospective Cohort Studies

Reference	Off-Loading Modality	Mean Healing Time	Type of Study	Percent Healed	Type of Wound
The Total Contact Cast for Management of Neuropathic Plantar Ulceration of the Foot Myerson, M J Bone Joint Surg, 1992	TCC	Forefoot Ulcers: 30days Rearfoot-Midfoot Ulcers: 63 days	Retrospective Cohort	90%	Wagner 1, 2
Total Contact Casting and Chronic Diabetic Neuropathic Fool Ulcerations: Healing Rates by Wound Location Walker, SC Arch Phys Med Rehabil, 1987	TCC	Forefoot Ulcers: 31 days Rearfoot-Midfoot Ulcers: 42 days	Retrospective Cohort		Wagner 1, 2, 3
Healing Rates of Plantar Ulcers in Leprosy and Diabetes Birke, JA Leprosy Review, 1992	TCC	40 days	Retrospective Cohort	94%	Wagner 1, 2
Total Contact Casting in Diabetic Patients with Neuropathic Foot Ulcerations Helm, PA Arch Phys Med Rehabil, 1984	TCC	38 days	Retrospective Cohort	73%	Wagner 1, 2, 3
Healing Rates of Diabetic Foot Ulcers Associated with Midfoot Fracture Due to Charcot's Arthropathy Lavery, LA Diabetic Medicine, 1997	TCC	Midfoot Ulcers: 28 days Charcot: 38 days	Retrospective Cohort	100%	Wagner 1. Charcot

Meta Analysis:
A meta-analysis representing 526 ulcers in 493 patients treated with TCC identified wound healing achieved in a mean time of 44 days in 88% of the ulcers.

Reference	Off-Loading Modality	Mean Healing Time	Type of Study	Percent Healed	Type of Wound
American Diabetes Association 60th Scientific Sessions, 2000 Bloomgarden, ZT Diabetes Care, 2001	Meta Analyasis TCC (n=526 ulcers)	44 days	Meta Analysis	88%
Nonsurgical Strategies for Healing and Preventing Recurrence of Diabetic Foot Ulcers Cavanaugh, PR Foot & Ankle Clinics, 2006	Meta Analyasis TCC (n=526 ulcers)	44 days	Meta Analysis	88%

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Total Contact Casting is a Gold Standard of
Care for treating Neuropathic Arthropathy

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Total Contact Casting is a Gold Standard of Care for treating Neuropathic Arthropathy

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Total Contact Casting is a Gold Standard of
Care for treating Neuropathic Arthropathy