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

March 16, 2006
March 16, 2006
August 2001
Not Provided
wound surface area reduction
Same as current
No Changes Posted
time to wound healing (days)
Same as current
Not Provided
Not Provided
 
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Neuropathic Foot Ulceration in Individuals With Diabetes
Device: cast vs. shoe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
43
April 2005
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00304733
2024
Not Provided
Not Provided
Rehabilitation Centre Amsterdam
  • ConvaTec Inc.
  • Ontwikkelingsfonds Orthopedisch maatschoeisel
Study Chair: f. b. van de weg, m.d. rehabiliation centre amsterdam
Rehabilitation Centre Amsterdam
August 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP