NCT01034813

Brief Summary

The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Specifically, this study will determine if differences in CFU recruitment exist between normal subjects and individuals with burn scars at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension, respectively.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

4.2 years

First QC Date

December 16, 2009

Last Update Submit

February 2, 2015

Conditions

Contractures Resulting From Burn Scar Tissue

Keywords

contractures, range of motion, scar formation

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    3-5 days

Secondary Outcomes (1)

  • Scar Hypertrophy

    3--5 days

Study Arms (2)

Burn Range of motion

burn patients with hypertropic scar

control range of motion

control subjects without scaring

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Military and civilian burn patients.Control population will be individuals without upper extremity injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAISR

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • Nedelec B, Correa JA, Rachelska G, Armour A, LaSalle L. Quantitative measurement of hypertrophic scar: interrater reliability and concurrent validity. J Burn Care Res. 2008 May-Jun;29(3):501-11. doi: 10.1097/BCR.0b013e3181710881.

    PMID: 18388576BACKGROUND

MeSH Terms

Conditions

Contracture

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular Diseases

Study Officials

  • William S Dewey, PT, CHT

    United States Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 18, 2009

Study Start

March 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

US(1)