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Diabetic Foot UlcersNCT00617916

Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers

An observational study of Diabetic Foot Ulcers, run by HyperMed at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Diabetic Foot Ulcers
How many people
256 participants
Where
3 sitesUnited States
Study dates
Mar 2006to Sep 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Clinic population - diabetic patients at high risk for ulceration

Who may be able to join

  • 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
  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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:
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Lerner Research Institute, The Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Pennslyvania Healthcare System

    Philadelphia, Pennsylvania, 19104

  • Olive View UCLA Medical Center

    Sylmar, California, 91342

Other trials in United States

About this study

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.

Keywords
hyperspectral imaging, tissue oxygenation, diabetic foot ulcers, wound healing, prevention
Medical subject headings
Diabetic Foot

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2008 (estimated)
  2. Study startMar 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617916
Sponsor's protocol ID
2005-001
Other IDs
R42DK069871
Status last verified
Jun 2009
First submitted
6 Feb 2008
Last updated
4 Jun 2009
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Ulcers, run by HyperMed at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00617916, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2009.

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