Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

March 16, 2006 updated by: Rehabilitation Centre Amsterdam
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.

Study Type

Interventional

Enrollment

43

Phase

  • Not Applicable

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

  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1090 hm
        • Onze Lieve Vrouwe Gasthuis

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:

  • confirmed diabetes
  • neuropathic ulcer grade 1/2 (wagner scale)
  • confirmed sensory neuropathy

Exclusion Criteria:

  • osteomyelitis patients unable to walk
  • life threatening co-morbidity ankle/brachial index , 0.4

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: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
wound surface area reduction

Secondary Outcome Measures

Outcome Measure
time to wound healing (days)

Collaborators and Investigators

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

Sponsor

Rehabilitation Centre Amsterdam

Collaborators

ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel

Investigators

  • Study Chair: f. b. van de weg, m.d., rehabiliation centre amsterdam

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

August 1, 2001

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2006

Last Update Submitted That Met QC Criteria

March 16, 2006

Last Verified

August 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 (Other Grant/Funding Number: Rome Foundation)

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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