NCT01005264

Removable Walker for Neuropathic Ulcers

Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IRCCS Multimedica · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer 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

Study design: 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

• Diabetic Foot

Interventions

Type	Name	Description
DEVICE	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
DEVICE	Stabil-D®	Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-10-30
• Last updated: 2009-10-30

Locations

1 site across 1 country: Italy