Removable Walker for Neuropathic Ulcers

October 29, 2009 updated by: IRCCS Multimedica

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Sesto San Giovanni, Milan, Italy, 20099
        • Diabetic Foot Center - IRCCS Multimedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND
  • 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 an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-removable fiberglass
Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus
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
Other Names:
  • Softcast3M®, 3M Health Care, St. Paul, MN (USA)
Active Comparator: Stabil-D®
Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole
Device: Stabil-D®
Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
Other Names:
  • Podartis srl, Montebelluna, Treviso, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in ulcer size
Time Frame: at 90th day
at 90th day

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete healing rate at the end of the study
Time Frame: at 90th day
at 90th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Multimedica

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/2007cardiovascolare

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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