Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

NCT00767923 | Unknown

• 1 other identifier: 2008-011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Conditions

Critical Limb Ischemia

Keywords

hyperspectral imaging; tissue oxygenation; foot amputation; critical limb ischemia; tissue necrosis

Outcome Measures

Primary Outcomes (1)

• Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.

  8 weeks

Secondary Outcomes (1)

• Collect additional interventions required through review of patient medical records at 12 months

  12 Months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.

You may qualify if:

• to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
• Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Sponsors & Collaborators

• HyperMed: lead
• Carl T. Hayden VA Medical Center: collaborator

Study Sites (1)

Carl T Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

Related Publications (9)

• Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992 May;6 Suppl A:1-32. No abstract available.

  PMID: 1533191 BACKGROUND

• Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.

  PMID: 1478041 BACKGROUND

• Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.

  PMID: 10919631 BACKGROUND

• Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.

  PMID: 10097914 BACKGROUND

• Harrington C, Zagari MJ, Corea J, Klitenic J. A cost analysis of diabetic lower-extremity ulcers. Diabetes Care. 2000 Sep;23(9):1333-8. doi: 10.2337/diacare.23.9.1333.

  PMID: 10977028 BACKGROUND

• 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

• Zuzak KJ, Schaeberle MD, Gladwin MT, Cannon RO 3rd, Levin IW. Noninvasive determination of spatially resolved and time-resolved tissue perfusion in humans during nitric oxide inhibition and inhalation by use of a visible-reflectance hyperspectral imaging technique. Circulation. 2001 Dec 11;104(24):2905-10. doi: 10.1161/hc4901.100525.

  PMID: 11739304 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

• Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.

  PMID: 15166566 BACKGROUND

Related Links

• Sponsor and OxyVu technology website

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Robert G Frykberg, DPM MPH

  Carl T. Hayden VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

US (1)