MedEfficiency, Inc.
Toll Free: (866) 357-7755
Phone: (303) 321-7755
Fax: (303) 321-6081
sales@medefficiency.com
5161 Ward Road, Unit 7
Wheat Ridge, CO 80033
Clinicians
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
References
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
|
TCC |
Forefoot Ulcers: 31 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% |