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

• Sponsor: Rehabilitation Centre Amsterdam (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00304733
• Collaborator: ConvaTec Inc. (Industry), Ontwikkelingsfonds Orthopedisch maatschoeisel (Other)
• Enrollment: 43
• Location: 1
• Duration (Months): 44
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neuropathic Foot Ulceration in Individuals With Diabetes	Device: cast vs. shoe	N/A

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 Design

• Study Type: Interventional
• 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
• Study Start Date: Aug 1, 2001
• Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

1. wound surface area reduction []

Secondary Outcome Measures

1. time to wound healing (days) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00304733
• Other Study ID Numbers: 2024
• First Posted: Mar 20, 2006
• Last Update Posted: Mar 20, 2006
• Last Verified: Aug 1, 2001

• Keywords provided by , ,: neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer

Study Results

No Results Posted as of Mar 20, 2006