Impaired Wound Healing in Diabetic Foot Ulceration (EPC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00739323
First received: August 19, 2008
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition
Diabetes Mellitus
Healthy Volunteers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impaired Wound Healing in Diabetic Foot Ulceration

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Enrollment: 137
Study Start Date: December 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739323

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Aristidis Veves, DSc Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Aristidis Veves, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00739323     History of Changes
Other Study ID Numbers: DK76937, R01DK076937, 1R01DK076937
Study First Received: August 19, 2008
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 28, 2014