Wound Healing: Total Contact Cast Vs. Custom-Made Tempora... | NCT00304733

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

NCT00304733

Sponsor

Rehabilitation Centre Amsterdam

Status

Unknown status

Last Update Posted

Mar 20, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Neuropathic Foot Ulceration in Individuals With Diabetes

Interventions

cast vs. shoe

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2001

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2001

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Mar 16, 2006

First Submission Date that Met QC Criteria

Mar 16, 2006

First Posted Date

Mar 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2006

Last Update Posted Date

Mar 20, 2006Estimated

Name	Class
ConvaTec Inc.	INDUSTRY
Ontwikkelingsfonds Orthopedisch maatschoeisel	UNKNOWN

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
cast vs. shoe	Device

Measure	Description	Time Frame
wound surface area reduction

Measure	Description	Time Frame
time to wound healing (days)

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
f. b. van de weg, m.d.	rehabiliation centre amsterdam	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onze Lieve Vrouwe Gasthuis		Amsterdam	North Holland	1090 hm	Netherlands