Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Information provided by:
Rehabilitation Centre Amsterdam Identifier:
First received: March 16, 2006
Last updated: NA
Last verified: August 2001
History: No changes posted
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 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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00304733

Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 hm
Sponsors and Collaborators
Rehabilitation Centre Amsterdam
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Study Chair: f. b. van de weg, m.d. rehabiliation centre amsterdam
  More Information Identifier: NCT00304733     History of Changes
Other Study ID Numbers: 2024
Study First Received: March 16, 2006
Last Updated: March 16, 2006

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

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Pathologic Processes processed this record on May 25, 2017