CompletedNCT00617916Updated Jun 4, 2009

Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers

An observational study in Diabetic Foot Ulcers, sponsored by HyperMed. Completed at 3 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-06-04.

Sponsored by HyperMed · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 256
Ages: 21 Years to 85 Years
Sex: All

Study 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.

Read the 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 centers. Each center will enroll 22 subjects (10 Type 1 and 12 Type 2). Subjects will be required to participate in eleven (11) clinic visits over a 6 month period. The first visit will last approximately three hours and each of the other visits will last about two hours. The eleven visits will be scheduled as follows in the Table to the right.

At the initial visit the subject will give informed consent and a full medical history, and will schedule the dates of the remaining visits for the study. The subject recruiter will contact each subject one week prior to each subsequent visit to either confirm the subject's attendance or to re-schedule the visit.

NEW ULCER PREDICTION STUDY: This is a study comparing measurements of 210 "high risk" diabetic subjects (90 Type 1 and 120 Type 2) over an 18-24 month period. The study will take place at three medical centers. Each center will enroll 70 subjects (30 Type 1 and 40 Type 2). Subjects will all be required to participate in nine (9) clinic visits. The nine visits will be scheduled as follows in the Table to the right.

The first visit will last approximately three hours and each of the other visits will last about 2 hours. At the initial visit the subject will give informed consent and a full medical history, and will schedule the dates of the visits for the rest of the study. The subject recruiter will contact each subject one week prior to each subsequent visit to either confirm the subject's attendance or to re-schedule the visit.

Conditions studied

Diabetic Foot Ulcers

Browse trials for

Keywords

hyperspectral imaging
tissue oxygenation
diabetic foot ulcers
wound healing
prevention

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 256 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

HyperMed is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Clinic population - diabetic patients at high risk for ulceration

Eligibility criteria

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:
1. 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
2. Presence of significant deformity
3. Peripheral vascular disease with ankle brachial index \< 0.7
4. History of previous ulceration or presence of a foot ulcer
5. 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 256 participants (actual)

Study locations

3 sites

Olive View UCLA Medical Center
Sylmar, California 91342, United States
Lerner Research Institute, The Cleveland Clinic
Cleveland, Ohio 44195, United States
University of Pennslyvania Healthcare System
Philadelphia, Pennsylvania 19104, United States

References and documents

Publications

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. PubMed 16291064 ↗
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. PubMed 16688075 ↗
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. PubMed 17303790 ↗
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. PubMed 17374984 ↗
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. PubMed 19641161 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00617916
Lead sponsor: HyperMed
Collaborators: The Cleveland Clinic, Olive View-UCLA Education & Research Institute, University of Pennsylvania
First posted: Feb 18, 2008
Start date: Mar 2006
Primary completion: Sep 2008
Completion: Sep 2008
Last update: Jun 4, 2009

Study contacts

Brian L Davis, PhD

principal investigator · The Cleveland Clinic

Aksone Nouvong, DPM

principal investigator · Olive View-UCLA Education & Research Institute

Emile Mohler, MD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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