Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers

NCT00617916 | Completed

• 2 other identifiers: 2005-001R42DK069871
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Diabetic Foot Ulcers

Keywords

hyperspectral imaging; tissue oxygenation; diabetic foot ulcers; wound healing; prevention

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinic population - diabetic patients at high risk for ulceration

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:
• 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

Sponsors & Collaborators

• HyperMed: lead
• The Cleveland Clinic: collaborator
• Olive View-UCLA Education & Research Institute: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

Location

Lerner Research Institute, The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennslyvania Healthcare System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Greenman RL, Panasyuk S, Wang X, Lyons TE, Dinh T, Longoria L, Giurini JM, Freeman J, Khaodhiar L, Veves A. Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet. 2005 Nov 12;366(9498):1711-7. doi: 10.1016/S0140-6736(05)67696-9.

  PMID: 16291064 BACKGROUND

• Cancio LC, Batchinsky AI, Mansfield JR, Panasyuk S, Hetz K, Martini D, Jordan BS, Tracey B, Freeman JE. Hyperspectral imaging: a new approach to the diagnosis of hemorrhagic shock. J Trauma. 2006 May;60(5):1087-95. doi: 10.1097/01.ta.0000217357.10617.3d.

  PMID: 16688075 BACKGROUND

• Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.

  PMID: 17303790 BACKGROUND

• Panasyuk SV, Yang S, Faller DV, Ngo D, Lew RA, Freeman JE, Rogers AE. Medical hyperspectral imaging to facilitate residual tumor identification during surgery. Cancer Biol Ther. 2007 Mar;6(3):439-46. doi: 10.4161/cbt.6.3.4018. Epub 2007 Mar 16.

  PMID: 17374984 BACKGROUND

• Nouvong A, Hoogwerf B, Mohler E, Davis B, Tajaddini A, Medenilla E. Evaluation of diabetic foot ulcer healing with hyperspectral imaging of oxyhemoglobin and deoxyhemoglobin. Diabetes Care. 2009 Nov;32(11):2056-61. doi: 10.2337/dc08-2246. Epub 2009 Jul 29.

  PMID: 19641161 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Brian L Davis, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Aksone Nouvong, DPM

  Olive View-UCLA Education & Research Institute

  PRINCIPAL INVESTIGATOR

• Emile Mohler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: March 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

US (3)