NCT00739323

Brief Summary

An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

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

December 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

August 19, 2008

Last Update Submit

February 27, 2017

Conditions

Diabetes MellitusHealthy Volunteers

Eligibility Criteria

Age21 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.

You may qualify if:

  • Current diagnosis of Type I or Type II Diabetes Mellitus.
  • Ulcer present for minimum 4 weeks
  • Have adequate circulation to the foot
  • Can return for follow-up visits
  • Be able to read and sign the Informed Consent form before enrollment

You may not qualify if:

  • Active Charcot's foot ulcer on the foot to be studied
  • Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
  • Alcohol or drug abuse problems
  • Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
  • Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Aristidis Veves, DSc

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

December 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(1)