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Removable Walker for Neuropathic Ulcers

NCT01005264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-10-30

No results posted yet for this study

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.

Conditions

  • Diabetic Foot

Interventions

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

Sponsors & Collaborators

  • IRCCS Multimedica

    lead OTHER

Principal Investigators

  • Ezio Faglia, MD · Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005264 on ClinicalTrials.gov