Diabetic foot ulceration (DFU) is currently the leading cause of diabetes-related hospitalization and non-traumatic lower extremity amputation. Excessive pressure is reported to contribute to delay in healing of up to 94% of these ulcerations.1 This, in conjunction with the high mortality rate reported following amputation, should emphasize the necessity of off-loading.2 Dr. Paul Brand introduced the total contact cast (TCC) to the U.S. in the 1960s, initially for treatment of leprosy-related neuropathic ulcerations.3 Its use gradually transitioned to treatment of DFUs with several randomized controlled trials, systematic reviews, meta-analyses, and a Cochrane review demonstrating a statistically significant increase in healing rates and reduction in healing times compared to other off-loading modalities.4-13 While this has resulted in the TCC being touted as the “gold standard” in off-loading, post-operative shoes and removable cast walkers are the most common off-loading modalities employed.14-16 Difficulty in training staff in proper application and removal of TCCs, disruption of clinic flow, the potential for iatrogenic complications, patient inability to tolerate the device, and contra-indication of use in patients with ischemia or Wagner Grade 3 DFUs are the most common barriers to use cited.4,6,7-9,13,17
Ready-to-use TCC kits have been developed to assist in minimizing barriers related to staff training, disruption of clinic flow, and the potential for iatrogenic complications by simplifying application and removal techniques and the process of ordering necessary supplies. Healing rates with these devices are comparable to those reported with conventional TCC use.18 Amputation secondary to iatrogenic complications sustained with conventional TCC have been reported.19,20 However, use of a ready-to-use prefabricated roll-on TCC kit reported no amputations occurring secondary to iatrogenic complications sustained with its use.18 Patient compliance is also an important consideration. Fourteen percent of iatrogenic complications have been reported to occur secondary to patients getting their cast wet and waiting until their next scheduled clinic appointment to be seen.20 The majority of iatrogenic complications are minor and reversible, with resolution occurring within less than two weeks if identified and treated early.18-20 Ready-to-use TCC kits with easy application and removal procedures and close patient follow-up and repetitive education on when to be seen earlier should mitigate the barriers of staff training, clinic flow disruption, and the concern for iatrogenic complications with TCC use.
Patient Intolerance of TCCs?
While patient intolerance of TCC use is a commonly mentioned barrier, there is no objective evidence to support this claim.4,5,8,14,18,21,22 Two studies that reported on patient satisfaction with treatment, not TCC use specifically, found rates to be equivalent between TCC and therapeutic shoes, and lower for conventional TCC compared to an “offthe-shelf instant” TCC.4,8 Only one study has reported specifically on patient tolerance of a ready-to-use type TCC.18 Tolerance of device use until wound resolution resulted in significantly shorter healing times. Even in some patients who refused continued applications, the short time of use either assisted in expediting or achieved wound resolution. No one wants to be in a cast. Explanation of its benefits for patients and their support network in expediting wound resolution and reducing the risk for infection and amputation may increase patient tolerance of TCC use. The majority of TCC studies involve treatment of small, superficial, non-infected, nonischemic plantar forefoot ulcerations.10,11,23-31 This, however, is not the typical DFU presenting for treatment. In the clinical practice, guidelines for management of the diabetic foot put forth by the Society for Vascular Surgery, the American Podiatric Medical Association and the Society for Vascular Medicine, at least 65% of DFUs are complicated by peripheral arterial disease (PAD).32 A five-year retrospective review of prospectively collected data on TCC use in all patients presenting to a single facility for treatment found that 44% had PAD defined as no signs of CLI and one or more of the following: absent palpable pedal pulses, presence of intermittent claudication, an ABI <0.9, a toe brachial index <0.6, and a TCOM between 30 and 60mmHg.21 The Eurodiale study, a one-year retrospective review of all patients presenting with a DFU to one of 14 diabetic foot centers in ten European countries found that 61% of patients had PAD; 49% with moderate PAD (ABI <0.9 or absent palpable pedal pulses), and 12% with severe PAD (ABI <0.5).34 Thirty-two percent of patients had a falsely elevated ankle-brachial index (ABI), making diagnosis of PAD severity difficult. The prevalence of PAD was found to increase with age > 70 and the presence of disabling co-morbidities. Validation of the IDSA DFI Severity Classification found that 82% of DFUs are mildly to moderately infected at presentation.33
TCC and Wagner Grade 3
While TCC use is contra-indicated for the treatment of Wagner Grade 3 DFUs and ischemia, it has been performed with successful results.17,18,21,24-26,29 Dr. Brand himself reported that “Only a small percent age of diabetic patients have vascular compromise to such an extent as to prevent a plantar foot ulcer from healing after the pressure of walking has been relieved.” He reported not having seen ischemia in patients with diabetes severe enough to prevent TCC use during 17 years of practice.34 A prospective, controlled clinical trial which included patients with PAD (ABI between 0.5 and 0.99) compared TCC use to daily dressing changes for ulceration treatment. A significant increase in healing rate and decreased time to healing occurred for those subjects treated with TCC use (90% at 1.4 months vs 32% at 2.2 months).25 The five-year retrospective review of TCC use in which 44% of patients had PAD reported an overall healing rate of 76% at a mean of 33 days.21 The presence of PAD did not hinder healing of any plantar first metatarsal head ulceration or contribute to the development of superficial iatrogenic ulceration.
PAD was included in a prospective, non-randomized trial comparing the use of a windowed TCC to an off-loading shoe.17 The TCC group had an increased healing rate and a decreased time to healing compared to the off-loading shoe group (81%, 2.3 ± 1.2 months vs. 70%, 4.5 ± 4.4 months, respectively) despite having significantly more patients with ulcerations of longer duration, greater width and depth; and midfoot location. Patient age and TCC use were the only two variables found to have a statistically significant positive prognostic factor for healing. A three-year retrospective review on the use of a prefabricated rollon TCC also reported comparable healing rates to conventional TCC use despite having treated subjects with larger ulcerations, mid- and rear-foot ulcerations, Wagner Grade 3 DFUs, and ulcerations complicated by mild to moderate PAD.24 The primary reasons reported to result in an increased time to healing were: refusal of continued TCC use, an HbA1c ≥ 8%, active or former tobacco use, and non-forefoot ulcer location. A recent retrospective and systematic review on TCC use in patients with PAD suggests that TCC use in patients with an ankle pressure ≥80mmHG, a toe pressure ≥ 74mmHg, an ABI ≥0.55, or a TBI ≥0.55 may be a viable treatment option for pressure-related neuropathic ulcerations. Once again, prolonged healing times and amputation were found to occur if TCC use was discontinued. Wounds in patients with mild to moderate PAD in which TCC treatment was utilized have not been reported to worsen, only fail to decrease in size. Repeat vascular evaluation is recommended should this occur.35
Effective off-loading is one of the most important factors in achieving rapid resolution of pressure-related DFUs. Although the TCC is the reported “gold standard” in off-loading, its use remains nominal. Provider performance of individual patient risk and benefit assessment in those with mild to moderate PAD and/ or infection, utilization of ready-to-use TCC kits, the ability to perform weekly and more urgent follow-up as needed, and performance of repetitive patient education on cast safety and maintenance should mitigate the common barriers cited for not using the most optimal off-loading modality for pressure-related neuropathic ulcerations.
Acknowledgements: The author would like to thank Valerie Marmolejo, DPM from www.scriptummedica. com for her assistance in writing of this article.
Originally Published in Podiatry Management, November 2018
1 Fleischli JG, Lavery LA, Vela SA, Ashry H, Lavery DC. 1997 William J. Stickel Bronze Award. Comparison of strategies for reducing pressure at the site of neuropathic ulcers. J Am Podiatr Med Assoc. 1997 Oct;87(10):466-72.
2 Jupiter DC, Thorud JC, Buckley CJ, Shibuya N. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. Int Wound J. 2016 Oct;13(5):892-903.
3 Birke JA, Novick A, Patout CA, Coleman WC. Healing rates of plantar ulcers in leprosy and diabetes. Lepr Rev. 1992;63(4):365-374.
4 Caravaggi C, Faglia E, De Giglio R, et al. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000;23(12):1746- 1751.
5 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(6):1019-1022.
6 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.
7 Katz IA, Harlan A, Miranda-Palma B, et al. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care. 2005;28(3):555-559.
8 Piaggesi A, Macchiarini S, Rizzo L, et al. 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. 2007;30(3):586-590.
9 Faglia E, Caravaggi C, Clerici G, et al. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes Care. 2010;33(7):1419-1423.
10 Morona JK, Buckley ES, Jones S, Reddin EA, Merlin TL. Comparison of the clinical effectiveness of different off-loading devices for the treatment of neuropathic foot ulcers in patients with diabetes: a systematic review and meta-analysis. Diabetes Metab Res Rev. 2013;29(3):183-93.
11 de Oliveira AL, Moore Z. Treatment of the diabetic foot by off-loading: a systematic review. J Wound Care.2015;24(12):560, 562-570.
12 Elraiyah T, Prutsky G, Domecq JP, et al. A systematic review and meta-analysis of off-loading methods for diabetic foot ulcers. J Vasc Surg. 2016;63(2 suppl):59S-68S.e1-2.
13 Lewis J, Lipp A. Pressure-relieving interventions for treat-ing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;31(1):CD002302.
14 Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure off-loading devices in diabetic foot ulcers: do we practice what we preach? Diabetes Care. 2008;31(11):2118-2119.
15 Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010;18(2):154-158.14.
16 Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: the gap between evidence and practice. Data from the US Wound Registry. Adv Skin Wound Care. 2014;27(7):310-316.
17 Ha Van G, Siney H, Hartmann-Heurtier A, Jacqueminet S, Greau F, Grimaldi A. Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety, and compliance. Diabetes Care. 2003;26(10):2848- 2852.
18 Arnold JF, Marmolejo V. Outcomes Achieved With Use of a Prefabricated Roll-On Total Contact Cast. Foot Ankle Int. 2017 Oct;38(10):1126-1131.Guyton GP. An analysis of iatrogenic complications from the total contact cast. Foot Ankle Int. 2005;26(11):903-907.
19 Owings TM, Nicolosi N, Suba JM, Botek G. Evaluating iatro-genic complications of the total-contact cast: an 8-year retro-spective review at Cleveland Clinic. J Am Podiatr Med Assoc. 2016;106(1):1-6.
20 Nabuurs-Franssen MH, Sleegers R, Huijberts MS, et al. Total contact casting of the diabetic foot in daily practice: a prospec-tive follow-up study. Diabetes Care. 2005;28(2):243-247.
21 Snyder RJ, Frykberg RG, Rogers LC, et al. The manage-ment of diabetic foot ulcers through optimal off-loading: building consensus guidelines and practical recommen-dations to improve outcomes. J Am Podiatr Med Assoc. 2014;104(6):555-567.
22 Helm PA, Walker SC, Pullium GF. Recurrence of neuropathic ulceration following healing in a total contact cast. Arch Phys Med Rehabil. 1991;72(12):967- 970.
23 Pollard JP, Le Quesne LP. Method of healing diabetic forefoot ulcers. Br Med J (Clin Res Ed). 1983;286(6363):436-437.
24 Mueller MJ, Diamond JE, Sinacore DR, et al. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Diabetes Care. 1989;12(6):384-388.
25 Myerson M, Papa J, Eaton K, Wilson K. The total-contact cast for management of neuropathic plantar ulceration of the foot. J Bone Joint Surg Am. 1992;74(2):261-269.
26 Sinacore DR, Mueller MJ, Diamond JE, Blair VP 3rd, Drury D, Rose SJ. Diabetic plantar ulcers treated by total contact casting. A clinical report. Phys Ther. 1987;67(10):1543-1549.
27 Sinacore DR. Total contact casting for diabetic neuropathic ulcers. Phys Ther. 1996;76(3):296-301.
28 Laing PW, Cogley DI, Klenerman L. Neuropathic foot ulceration treated by total contact casts. J Bone Joint Surg Br. 1992;74(1):133-136.
29 Musa HG, Ahmed ME. Associated risk factors and management of chronic diabetic foot ulcers exceeding 6 months’ duration. Diabet Foot Ankle. 2012;3.
30 Birke JA, Pavich MA, Patout CA Jr, Horswell R. Comparison of forefoot ulcer healing using alternative off-loading methods in patients with diabetes mellitus. Adv Skin Wound Care. 2002;15(5):210 – 215.
31 Hingorani A, LaMuraglia GM, Henke P, Meissner MH, Loretz L, Zinszer KM, Driver VR, Frykberg R, Carman TL, Marston W, Mills JL Sr, Murad MH. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S.
32 Lavery LA, Armstrong DG, Murdoch DP, Peters EJ, Lipsky BA. Validation of the Infectious Diseases Society of America’s diabetic foot infection classification system. Clin Infect Dis. 2007 Feb 15;44(4):562-5.
33 Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25.
34 Coleman WC, Brand PW, Birke JA. The total contact cast. A therapy for plantar ulceration on insensitive feet. J Am Podiatry Assoc. 1984 Nov;74(11):548-52.
35 Tickner A, Klinghard C, Arnold JF, Marmolejo V. Total Contact Cast Use in Patients With Peripheral Arterial Disease: A Case Series and Systematic Review. Wounds. 2018 Feb;30(2):49-56.