Impaired Wound Healing in Diabetic Foot Ulceration (EPC)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Healthy Volunteers

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).

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Aristidis Veves, DSc, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 21, 2008

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 2006P000335; R01DK076937 (U.S. NIH Grant/Contract); 1R01DK076937 (U.S. NIH Grant/Contract)