NCT00137228

Brief Summary

The purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 8, 2008

Status Verified

December 1, 2007

First QC Date

August 25, 2005

Last Update Submit

December 24, 2007

Conditions

Edema

Keywords

Hand EdemaFigure of eight methodMeasuring edema in burn patients

Outcome Measures

Primary Outcomes (1)

  • The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.

    24 hours

Interventions

figure-of-eight hand measurementsPROCEDURE
water volumetry hand measurementsPROCEDURE

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18-89 years old
  • Admitted to the United States (U.S.) Army Burn Intensive Care Unit (ICU) or ward with burn injury and the presence of bilateral or unilateral hand edema

You may not qualify if:

  • Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry.
  • Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
  • Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.S. Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • Leard JS, Breglio L, Fraga L, Ellrod N, Nadler L, Yasso M, Fay E, Ryan K, Pellecchia GL. Reliability and concurrent validity of the figure-of-eight method of measuring hand size in patients with hand pathology. J Orthop Sports Phys Ther. 2004 Jun;34(6):335-40. doi: 10.2519/jospt.2004.34.6.335.

    PMID: 15233395BACKGROUND

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott Dewey, PT, CHT, OCS

    US Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

January 1, 2005

Study Completion

November 1, 2006

Last Updated

January 8, 2008

Record last verified: 2007-12

Locations

US(1)