Status:
COMPLETED
Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers
Lead Sponsor:
HyperMed
Collaborating Sponsors:
The Cleveland Clinic
Olive View-UCLA Education & Research Institute
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
21-85 years
Brief Summary
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 hea...
Detailed Description
ULCER HEALING STUDY: This is a study comparing measurements from a cohort of 66 diabetic subjects (30 Type 1 and 36 Type 2) with at least one foot ulcer. The study will take place at three medical cen...
Eligibility Criteria
Inclusion
- Ulcer Healing 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.
- Presence of at least one foot ulcer
- 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 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00617916
Start Date
March 1 2006
End Date
September 1 2008
Last Update
June 4 2009
Active Locations (3)
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1
Olive View UCLA Medical Center
Sylmar, California, United States, 91342
2
Lerner Research Institute, The Cleveland Clinic
Cleveland, Ohio, United States, 44195
3
University of Pennslyvania Healthcare System
Philadelphia, Pennsylvania, United States, 19104