Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2008-02-29
2009-03-31
Brief Summary
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2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Detailed Description
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Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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non-removable fiberglass
Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus
non-removable fiberglass
Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus
Stabil-D®
Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole
Stabil-D®
Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
Interventions
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non-removable fiberglass
Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus
Stabil-D®
Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus \> 25 volts.
Exclusion Criteria
* Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,
* The probe-to-bone maneuver was required to be negative,
* Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,
* Use of steroids or cytostatic drugs,
* Presence of sensory, motor, or visual problems that could impair functional autonomy,
* Active ulcer on the contralateral foot,
* Previous major amputation of the contralateral limb,
* Previous or current deep venous leg thrombosis, OR
* Mental disorders interfering with patient compliance.
18 Years
80 Years
ALL
No
Sponsors
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IRCCS Multimedica
OTHER
Responsible Party
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Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
Principal Investigators
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Ezio Faglia, MD
Role: PRINCIPAL_INVESTIGATOR
Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
Locations
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Diabetic Foot Center - IRCCS Multimedica
Sesto San Giovanni, Milan, Italy
Countries
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References
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Caravaggi C, Sganzaroli A, Fabbi M, Cavaiani P, Pogliaghi I, Ferraresi R, Capello F, Morabito A. 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. 2007 Oct;30(10):2577-8. doi: 10.2337/dc07-0990. Epub 2007 Jun 11. No abstract available.
Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. 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 Mar;30(3):586-90. doi: 10.2337/dc06-1750.
Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. 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 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.
Faglia E, Caravaggi C, Clerici G, Sganzaroli A, Curci V, Vailati W, Simonetti D, Sommalvico F. 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 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.
Other Identifiers
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05/2007cardiovascolare
Identifier Type: -
Identifier Source: org_study_id