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OpenTrials
Completed

NCT Number: NCT00739323

Impaired Wound Healing in Diabetic Foot Ulceration

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.

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Key information

Age range

21 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: EPC

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2008
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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