Advertisement
-
1
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, et al: The global burden of diabetic foot disease. .Lancet 366::1719. ,2005. .
-
2
Wild S, Roglic G, Green A, et al: Prevalence of diabetes: estimates for the year 2000 and projections for 2030. .Diabetes Care 27::1047. ,2004. .
-
3
Litzelman DK, Marriot DJ, Vinicor F: Independent physiological predictors of foot lesions in patients with NIDDM. .Diabetes Care 20::1273. ,1997. .
-
4
Frykberg RG, Lavery LA, Pham H, et al: Role of neuropathy and high foot pressures in diabetic foot ulceration. .Diabetes Care 21::1714. ,1998. .
-
5
Boulton AJ: Clinical presentation and management of diabetic neuropathy and foot ulceration. .Diabet Med 8::552. ,1991. .
-
6
Sanders JE, Greve JM, Mitchell SB, et al: Material properties of commonly-used interface materials and their static coefficients of friction with skin and socks. .J Rehabil Res Dev 35::161. ,1998. .
-
7
Lewis LN, Colborn RE, Grade H, et al: Mechanism of formation of platinum complexes containing silicon-vinyl ligands. .Organometallics 14::2202. ,1995. .
-
8
Bus SA, Maas M, de Lange A, et al: Elevated plantar pressures in neuropathic diabetic patients with claw/hammer toe deformity. .J Biomech 38::1918. ,2005. .
-
9
Bus SA, Ulbrecht JS, Cavanagh PR: Pressure relief and load redistribution by custom-made insoles in diabetic patients with neuropathy and foot deformity. .Clin Biomech 19::629. ,2004. .
-
10
Piaggesi A, Romanelli M, Schipani E, et al: Hardness of plantar skin in diabetic neuropathic feet. .J Diabetes Complications 13::129. ,1999. .
-
11
Apelqvist J, Bakker K, van Houtum WH, et al: International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot. .Diabetes Metab Res Rev 16: (suppl 1):S84. ,2000. .
-
12
Mueller MJ, Hastings M, Commean PK, et al: Forefoot structural predictors of plantar pressures during walking in people with diabetes and peripheral neuropathy. .J Biomech 36::1009. ,2003. .
-
13
Bus SA, Maas M, Cavanagh PR, et al: Plantar fat-pad displacement in neuropathic diabetic patients with toe deformity: a magnetic resonance imaging study. .Diabetes Care 27::2376. ,2004. .
-
14
McNeely MJ, Boyko EJ, Ahroni JH, et al: The independent contributions of diabetic neuropathy and vasculopathy in foot ulceration. How great are the risks?. Diabetes Care 18::216. ,1995. .
-
15
Murray HJ, Young MJ, Hollis S, et al: The association between callus formation, high pressures and neuropathy in diabetic foot ulceration. .Diabet Med 13::979. ,1996. .
-
16
Prompers L, Huijberts M, Apelqvist J, et al: High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. .Diabetologia 50::18. ,2007. .
-
17
Freeman DB: Corns and calluses resulting from mechanical hyperkeratosis. .Am Fam Physician 65::2277. ,2002. .
-
18
Armstrong DG, Lavery LA, Nixon BP, et al: It’s not what you put on, but what you take off: techniques for debriding and off-loading the diabetic foot wound. .Clin Infect Dis 39: (Suppl 2):S92. ,2004. .
-
19
Piaggesi A, Viacava P, Rizzo L, et al: Semiquantitative analysis of the histopathological features of the neuropathic foot ulcer: effect of pressure relief. .Diabetes Care 26::3123. ,2003. .
-
20
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. .Diabetes Care 23::1746. ,2000. .
-
21
Armstrong DG, Ngyugen HC, Lavery LA, et al: Off-loading the diabetic foot wound: a randomized clinical trial. .Diabetes Care 24::1019. ,2001. .
-
22
Mueller MJ, Lott DJ, Hastings MK, et al: Efficacy and mechanism of orthotic devices to unload metatarsal heads in people with diabetes and a history of plantar ulcers. .Phys Ther 86::833. ,2006. .
-
23
Armstrong DG, Lavery LA, Kimbriel HR, 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 26::2595. ,2003. .
Effectiveness and Safety of Using Podikon Digital Silicone Padding in the Primary Prevention of Neuropathic Lesions in the Forefoot of Diabetic Patients
Background: In diabetic patients with complications from peripheral neuropathy, the hyperpressure areas can rapidly lead to ulcerative lesions in the absence of protective sensation. Partial digital silicone orthoses could provide an innovative and functional therapeutic solution in the management of preulcerative areas of the forefoot in neuropathic diabetic patients. We clinically tested this hypothesis.
Methods: Digital off-loading silicone padding was prepared for 89 neuropathic patients with deformities and localized hyperkeratosis in the forefoot. After 3 months and in basal conditions, the number of areas of hyperkeratosis was evaluated together with the hardness of the skin, the number of active lesions, and any adverse events associated with use of the orthosis. The patients were compared to a control group of 78 randomized patients undergoing standard therapy. In a subgroup of 10 patients, a static and dynamic biomechanical evaluation was also conducted with a computerized podobarometric platform.
Results: Both the number of lesions and the prevalence of hyperkeratosis and skin hardness were significantly lower (P < .01) in the group treated with the silicone orthoses than in the control group. No adverse events were reported during the 3 months of observation. The podobarometric analysis highlighted a significant (P < .001) reduction of peak pressure in the areas undergoing orthotic correction.
Conclusions: Silicone padding is effective and safe in the prevention of lesions in neuropathic patients at high risk of ulceration and significantly reduces the incidence of new lesions in the 3-month follow-up period compared to standard treatment. (J Am Podiatr Med Assoc 99(1): 28–34, 2009)
