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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 because the information has not been verified recently.
Verified August 2001 by Rehabilitation Centre Amsterdam.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Information provided by:
Rehabilitation Centre Amsterdam
ClinicalTrials.gov Identifier:
NCT00304733
First received: March 16, 2006
Last updated: NA
Last verified: August 2001
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00304733     History of Changes
Other Study ID Numbers: 2024
Study First Received: March 16, 2006
Last Updated: March 16, 2006
Health Authority: Netherlands: Independent Ethics Committee
Netherlands: Onze Lieve Vrouwe Gasthuis

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

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

ClinicalTrials.gov processed this record on May 21, 2013