NCT00125086

Brief Summary

This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Shorter than P25 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

July 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

July 27, 2005

Last Update Submit

September 12, 2005

Conditions

Wounds

Keywords

woundshealingAcute wounds healing by secondary intention

Outcome Measures

Primary Outcomes (1)

  • Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35

Secondary Outcomes (2)

  • Measurements of wound depth at each visit

  • Measurement of residual scarring at 6 months post wounding

Interventions

autologous platelet gelDEVICE

Eligibility Criteria

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

You may qualify if:

  • Normal volunteers
  • years old or older

You may not qualify if:

  • Pregnant or lactating
  • Diabetic, keloid former, collagen vascular disease
  • Smoker
  • Body mass index \>30kg/m2
  • Known history of HIV/AIDS; Hepatitis A, B, or C
  • Bleeding disorder
  • Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
  • Cancer, or treatment for cancer, in past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • David Hom, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Start

July 1, 2005

Study Completion

February 1, 2006

Last Updated

September 14, 2005

Record last verified: 2005-09

Locations

US(1)