NCT02082041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

March 4, 2014

Last Update Submit

September 12, 2016

Conditions

Wound Formation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Wounds on leg

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with wounds on their legs, wound clinic patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sparrow Wound Clinic

Lansing, Michigan, 48824, United States

Location

Study Officials

  • Tamara Bush, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 10, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

US(1)