Impaired Wound Healing in Diabetic Foot Ulceration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Diabetes Mellitus Healthy Volunteers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes