NCT00215735

Brief Summary

Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

9 active sites

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

September 14, 2005

Last Update Submit

March 16, 2012

Conditions

Diabetes

Keywords

diabetesUlcerAPC

Study Arms (1)

APC Treatment

EXPERIMENTAL

wound debridement and treatment with APC

Device: debridement, dressing, and APC

Interventions

debridement, dressing, and APCDEVICE

ebridement, dressing, and APC

APC Treatment

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Washington Regional Medical Center

Fayetteville, Alaska, 72703, United States

Location

Lucerne Hospital

Orlando, Florida, 32806, United States

Location

Bay Pines V.A. Medical Center

St. Petersburg, Florida, 33708, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Traveling Medical Services

Southfield, Michigan, 48075, United States

Location

Blair Medical Associates

Altoona, Pennsylvania, 16602, United States

Location

Roger Williams Hospital

Providence, Rhode Island, 02908, United States

Location

Tennessee Christian Hospital

Madison, Tennessee, 37115, United States

Location

St. Luke's Medical Ctr

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Diabetes MellitusUlcer

Interventions

DebridementBandagesArgon Plasma Coagulation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeEquipment and SuppliesElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesHemostasis, Surgical

Study Officials

  • Mark Iafrati, MD

    Tufts Medical Ctr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(9)