Diabetes Care, Vol 23, Issue 12 1746-1751, Copyright © 2000 by American Diabetes Association

ARTICLES

Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study

C Caravaggi, E Faglia, R De Giglio, M Mantero, A Quarantiello, E Sommariva, M Gino, C Pritelli and A Morabito
Center for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso, Sesto S. Giovanni, Milan, Italy. cara@mail3.telnetwork.it

OBJECTIVE: To evaluate and compare the rate of reduction of the surface area of neuropathic plantar ulcers in diabetic patients treated with nonremovable rigidity-differentiated fiberglass off-bearing casts or a cloth shoe with a rigid sole with unloading alkaform insoles. The secondary aim was to evaluate the side effects and degree of patient acceptance of treatment. RESEARCH DESIGN AND METHODS: Fifty diabetic patients with neuropathic plantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Of the 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unloading alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bearing fiberglass cast (cast group). All patients in both study groups returned to the clinic for weekly control visits. Their ulcers were treated with a standard dressing. Tracings of the ulcer area using a transparent dressing were performed on the day of entry to the study and after 30 days of treatment. The presence of new ulcerations caused by the use of the pressure-relief apparatus was recorded. Patient acceptance of the treatment was measured using a visual analog scale. RESULTS: At the end of the treatment period, an 8.3% increase of the ulcer area was observed in two patients in the shoe group, whereas in the cast group, no patient presented an increase. The reduction of the ulcer area was statistically more rapid in the cast group (Mann-Whitney test, P = 0.0004). Furthermore, the number of ulcers completely healed at the 30-day time point was 13 (50%) in the cast group and 5 (20.8%) in the shoe group (P = 0.03). In both groups, no side effects were recorded. The average score +/- SD of patient acceptance was 91.15 +/- 9.9 in the shoe group and 88.33 +/- 17.3 (NS) in the cast group. CONCLUSIONS: Our study has shown a significant difference in the speed of the reduction of neuropathic plantar ulcers treated with a fiberglass cast compared with a specialized cloth shoe. The use of fiberglass material with variable rigidity has also shown two important results: the elimination of side effects including ulcers caused by the cast, and high patient acceptance. These data show that the use of off-bearing casts made with fiberglass bandages of variable rigidity is the elective treatment of neuropathic plantar ulcers.
CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				C. Caravaggi, A. Sganzaroli, M. Fabbi, P. Cavaiani, I. Pogliaghi, R. Ferraresi, F. Capello, and A. Morabito Nonwindowed Nonremovable Fiberglass Off-Loading Cast Versus Removable Pneumatic Cast (AircastXP Diabetic Walker) in the Treatment of Neuropathic Noninfected Plantar Ulcers: A randomized prospective trial Diabetes Care, October 1, 2007; 30(10): 2577 - 2578. [Full Text] [PDF]

				A. Piaggesi, S. Macchiarini, L. Rizzo, F. Palumbo, A. Tedeschi, L. A. Nobili, E. Leporati, V. Scire, I. Teobaldi, and S. Del Prato 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 1, 2007; 30(3): 586 - 590. [Abstract] [Full Text] [PDF]

				V. Dini, M. Romanelli, A. Piaggesi, A. Stefani, and F. Mosca Cutaneous tissue engineering and lower extremity wounds (part 2). International Journal of Lower Extremity Wounds, March 1, 2006; 5(1): 27 - 34. [Abstract] [PDF]

				A. P. Garrow, C. H.M. van Schie, and A. J.M. Boulton Efficacy of Multilayered Hosiery in Reducing In-Shoe Plantar Foot Pressure in High-Risk Patients With Diabetes Diabetes Care, August 1, 2005; 28(8): 2001 - 2006. [Abstract] [Full Text] [PDF]

				M. H. Nabuurs-Franssen, M. S.P. Huijberts, R. Sleegers, and N. C. Schaper Casting of Recurrent Diabetic Foot Ulcers: Effective and safe? Diabetes Care, June 1, 2005; 28(6): 1493 - 1494. [Full Text] [PDF]

				D. G. Armstrong, L. A. Lavery, S. Wu, and A. J.M. Boulton Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wounds: A randomized controlled trial Diabetes Care, March 1, 2005; 28(3): 551 - 554. [Abstract] [Full Text] [PDF]

				M. H. Nabuurs-Franssen, R. Sleegers, M. S. Huijberts, W. Wijnen, A. P. Sanders, G. Walenkamp, and N. C. Schaper Total Contact Casting of the Diabetic Foot in Daily Practice: A prospective follow-up study Diabetes Care, February 1, 2005; 28(2): 243 - 247. [Abstract] [Full Text] [PDF]

				D. G. Armstrong and A. J. M. Boulton Pressure Offloading and "Advanced" Wound Healing: Isn't It Finally Time for an Arranged Marriage? International Journal of Lower Extremity Wounds, December 1, 2004; 3(4): 184 - 187. [PDF]

				M. J. Jannink, H. van Dijk, J. de Vries, J. W Groothoff, and G. J Lankhorst A systematic review of the methodological quality and extent to which evaluation studies measure the usability of orthopaedic shoes Clinical Rehabilitation, January 1, 2004; 18(1): 15 - 26. [Abstract] [PDF]

				A. Piaggesi, P. Viacava, L. Rizzo, G. Naccarato, F. Baccetti, M. Romanelli, V. Zampa, and S. Del Prato Semiquantitative Analysis of the Histopathological Features of the Neuropathic Foot Ulcer: Effects of pressure relief Diabetes Care, November 1, 2003; 26(11): 3123 - 3128. [Abstract] [Full Text] [PDF]

				C. Caravaggi, R. De Giglio, C. Pritelli, M. Sommaria, S. Dalla Noce, E. Faglia, M. Mantero, G. Clerici, P. Fratino, L. Dalla Paola, et al. HYAFF 11-Based Autologous Dermal and Epidermal Grafts in the Treatment of Noninfected Diabetic Plantar and Dorsal Foot Ulcers: A prospective, multicenter, controlled, randomized clinical trial Diabetes Care, October 1, 2003; 26(10): 2853 - 2859. [Abstract] [Full Text] [PDF]

				Managing foot ulcers in patients with diabetes DTB, February 1, 2002; 40(2): 11 - 14. [Abstract] [Full Text] [PDF]

				R. G. Frykberg, L. F. Bailey, A. Matz, L. A. Panthel, and G. Ruesch Offloading Properties of a Rocker Insole: A Preliminary Study J Am Podiatr Med Assoc, January 1, 2002; 92(1): 48 - 53. [Abstract] [Full Text] [PDF]