Measurement of Blood Perfusion in Response to Loading in... | NCT02082041

Studies
Measurement of Blood Perfusion in Response to Loading in Patients With Wounds

NCT02082041

Sponsor

Michigan State University

Status

Completed

Last Update Posted

Sep 14, 2016Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

Wound Formation

Interventions

Not provided

Countries

United States

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 10, 2014Estimated

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

Sep 12, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor the skin blood flow in the lower leg, with different levels and types of applied loads. These loads will not be placed over the patient's wound nor will they be higher than loads the skin normally experiences in daily activities. The results of this research will help investigators understand the development of pressure ulcers, commonly known as bedsores and stasis ulcers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Label	Type	Description	Intervention Names
Wounds on leg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in perfusion	Skin perfusion will be measured as different loads are applied to the leg.	Cross-sectional, evaluation time frame is approximately 2 hours occuring at the time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients are eligible if he/she has a wound on one or both legs.

Exclusion Criteria:

under the age of 18
individuals with mental illness
individuals who are unable to sit for an hour
individuals whose wound care method prohibits testing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with wounds on their legs, wound clinic patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tamara Bush, PhD	Michigan State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sparrow Wound Clinic		Lansing	Michigan	48824	United States