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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuropathic Foot Ulceration in Individuals With Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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cast vs. shoe

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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f. b. van de weg, m.d.

Role: STUDY_CHAIR

rehabiliation centre amsterdam

Locations

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Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2024

Identifier Type: -

Identifier Source: org_study_id