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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2001 by Rehabilitation Centre Amsterdam.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304733
First Posted: March 20, 2006
Last Update Posted: March 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Information provided by:
Rehabilitation Centre Amsterdam
  Purpose
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

Condition Intervention
Neuropathic Foot Ulceration in Individuals With Diabetes Device: cast vs. shoe

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Resource links provided by NLM:


Further study details as provided by Rehabilitation Centre Amsterdam:

Primary Outcome Measures:
  • wound surface area reduction

Secondary Outcome Measures:
  • time to wound healing (days)

Estimated Enrollment: 43
Study Start Date: August 2001
Estimated Study Completion Date: April 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304733


Locations
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 hm
Sponsors and Collaborators
Rehabilitation Centre Amsterdam
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Investigators
Study Chair: f. b. van de weg, m.d. rehabiliation centre amsterdam
  More Information

ClinicalTrials.gov Identifier: NCT00304733     History of Changes
Other Study ID Numbers: 2024
First Submitted: March 16, 2006
First Posted: March 20, 2006
Last Update Posted: March 20, 2006
Last Verified: August 2001

Keywords provided by Rehabilitation Centre Amsterdam:
neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Foot Diseases