NCT00759499

Brief Summary

Debridement Samples being collected for future or immediate research purposes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
829

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

14.1 years

First QC Date

September 24, 2008

Last Update Submit

July 9, 2020

Conditions

Keywords

study of debridement tissue for research purposes.open wound

Outcome Measures

Primary Outcomes (1)

  • The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies.

    2 years

Study Arms (1)

Debridement

The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies. This clinical wound material can be studied in order to better understand the molecular, cellular, or ecological components of the wound system. These studies may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be identified because their wound(s) possesses something of special interest. A special interest wound can include, but will not be limited to wounds that are rapidly deteriorating, wounds diagnosed as pyoderma gangrenosum, wounds showing unusually rapid wound healing, wounds with abnormal microorganisms, non-healing wounds, young wounds, and others.

You may qualify if:

  • The subject must have a full thickness wound.
  • The subject must be a candidate for sharp debridement.
  • The subject must be 18 years of age or older
  • The subject must be mentally competent as determined by the Principal Investigator

You may not qualify if:

  • The subject may not be currently incarcerated or pregnant.
  • Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soutwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Randall D Wolcott, M.D.

    Southwest Regional Wound Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

January 1, 2007

Primary Completion

January 18, 2021

Study Completion

January 18, 2021

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations