Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers

Completed

Conditions studied: Diabetic Foot Ulcers

In brief

This study is designed to test a prototype imaging instrument that relies on Medical HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot ulceration and wound healing. The imaging system utilizes the biomarkers of oxyhemoglobin (oxyHb) and deoxyhemoglobin (deoxyHb), in the upper layers of skin on the foot as: a metric for assessing wound healing, a reflection of microvascular disease, and determining tissue at risk for forming new ulcers. MHSI results will also be compare with ABI and TcPO2 measurements.

Key facts

Study ID: NCT00617916
Run by: HyperMed
People needed: 256
Starts: 2006-03-01
Expected to finish: 2008-09-01
Last updated by the study team: 2009-06-04

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with Type 1 diabetes (defined as diabetes beginning before age 35, requiring insulin, and diagnosed with diabetes for more than six months) or Type 2 diabetes.
Presence of at least one foot ulcer

You may not qualify if…

Peripheral arterial occlusive disease (PAD) that is severe enough to require surgical bypass operation.
Cardiovascular disease as demonstrated in only these instances: congestive heart failure that leads to severe edema at the lower extremity, stroke or transient ischemic attack with residual nerve dysfunction.
Uncontrolled hypertension: SBP>190 mmHg or DBP > 110 mmHg
End stage renal disease (subjects on renal dialysis or kidney transplantation)
Any other serious chronic disease that can affect wound healing
Subjects currently on any of the following medications: Glucocorticoids, Antineoplastics
Females if lactating or pregnant or, if of childbearing potential, unwilling to use standard birth control. All females of childbearing potential will undergo a pregnancy test during each visit.
NEW ULCER PREDICTION STUDY:
Inclusion criteria:
Subjects with Type 1 diabetes (defined as diabetes beginning before age 35, requiring insulin, and diagnosed with diabetes for more than six months) or Type 2 diabetes.
Subject without foot ulcers but at "high risk" for foot ulceration. In order to define "high risk" for this study, we are using the International Working Group standards:
Advanced neuropathy, defined by loss of protective sensation in the foot with a vibrational perception threshold (VPT) over 25mHz or inability to detect Semmes Weinstein 5.07 (10g) monofilament
Presence of significant deformity
Peripheral vascular disease with ankle brachial index < 0.7
History of previous ulceration or presence of a foot ulcer
At least one foot that is ulcer free at the time of enrollment
Exclusion criteria:
Peripheral arterial occlusive disease (PAD) that is severe enough to require surgical bypass operation.
Cardiovascular disease as demonstrated in only these instances: congestive heart failure that leads to severe edema at the lower extremity, stroke or transient ischemic attack with residual nerve dysfunction.
Uncontrolled hypertension: SBP > 190 mmHg or DBP > 110 mmHg
End stage renal disease (subjects on renal dialysis or kidney transplantation)
Any other serious chronic disease that can affect wound healing
Subjects on any of the following medications: Glucocorticoids and Antineoplastic agents
Females if lactating or pregnant or, if of childbearing potential, unwilling to use standard birth control. All females of childbearing potential will undergo a pregnancy test during each visit.

Where it is running

Olive View UCLA Medical Center — Sylmar, California, United States
Lerner Research Institute, The Cleveland Clinic — Cleveland, Ohio, United States
University of Pennslyvania Healthcare System — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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