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

This study is ongoing, but not recruiting participants.

First Received: March 16, 2006 No Changes Posted

Sponsors and Collaborators:	Rehabilitation Centre Amsterdam ConvaTec Inc. Ontwikkelingsfonds Orthopedisch maatschoeisel
Information provided by:	Rehabilitation Centre Amsterdam
ClinicalTrials.gov Identifier:	NCT00304733

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

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

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, Noord Holland
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

Study ID Numbers:	2024
Study First Received:	March 16, 2006
Last Updated:	March 16, 2006
ClinicalTrials.gov Identifier:	NCT00304733 History of Changes
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

Study placed in the following topic categories:

Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on May 06, 2009