Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg

NCT01804478 | Completed

• 1 other identifier: 091793
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

SPECIFIC AIMS The limbs of diabetic patients are associated with decreases in capillary density, arterial inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing and viability of tissue, especially in patients with peripheral vascular disease and diabetes. The investigators hypothesize that mild external compression can restore the decreases in skin and muscle blood flow and that there would be greater increases in microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow will be measured using Photoplethysmography (PPG) before, during, and after external compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS). The specific aims are:

• To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF) microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
• To measure muscle oxygenation changes in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
• To optimize pressures of Continuous Compression to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
• To optimize compression pressures, duration, and frequency of Intermittent Pneumatic Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
• To measure microcirculatory response to compression in patients with diabetes
• Continue to validate of photoplethysmography as a tool for measuring microcirculation.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Muscle Blood Flow

  To measure muscle blood flow microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.

  12 months

Secondary Outcomes (1)

• Skin Blood Flow

  12 months

Study Arms (1)

Pneumatic Compression

EXPERIMENTAL

Both diabetic and control subjects will undergo mild pneumatic compression while tissue oxygenation and blood flow are recorded with a non-invasive NIRS and PPG device

Behavioral: Mild pneumatic compression

Interventions

Mild pneumatic compression BEHAVIORAL

Pneumatic Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of lower extremity vascular diseases such as atherosclerosis, intermittent claudication, acute or chronic deep venous thrombosis, presence of ankle edema, stasis dermatitis, active lower extremity ulcers or wounds, diabetic foot ulcers, diabetic neuropathy, history of lower extremity surgery.
• Pregnant women.
• Patients with abnormally large or misshapen legs.
• Patients with existing ulcers.
• Patients with poor underlying health.
• Patients with allergies to the study materials.
• Patients who recently developed deep venous thrombosis (6 months)
• Patients with congenital A/V malformations.
• Patients with paraplegia.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (23)

• Morris RJ, Woodcock JP. Evidence-based compression: prevention of stasis and deep vein thrombosis. Ann Surg. 2004 Feb;239(2):162-71. doi: 10.1097/01.sla.0000109149.77194.6c.

  PMID: 14745323 BACKGROUND

• Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, Comerota AJ Jr. Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg. 1996 Aug;172(2):130-4; discussion 135. doi: 10.1016/S0002-9610(96)00134-1.

  PMID: 8795514 BACKGROUND

• Eze AR, Cisek PL, Holland BS, Comerota AJ Jr, Verramasuneni R, Comerota AJ. The contributions of arterial and venous volumes to increased cutaneous blood flow during leg compression. Ann Vasc Surg. 1998 Mar;12(2):182-6. doi: 10.1007/s100169900138.

  PMID: 9514239 BACKGROUND

• van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8. doi: 10.1016/s0741-5214(94)70217-9.

  PMID: 8201706 BACKGROUND

• Trent JT, Falabella A, Eaglstein WH, Kirsner RS. Venous ulcers: pathophysiology and treatment options. Ostomy Wound Manage. 2005 May;51(5):38-54; quiz 55-6.

  PMID: 16014984 BACKGROUND

• Abu-Own A, Cheatle T, Scurr JH, Coleridge Smith PD. Effects of intermittent pneumatic compression of the foot on the microcirculatory function in arterial disease. Eur J Vasc Surg. 1993 Sep;7(5):488-92. doi: 10.1016/s0950-821x(05)80358-5.

  PMID: 8405490 BACKGROUND

• Delis KT, Labropoulos N, Nicolaides AN, Glenville B, Stansby G. Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):270-7. doi: 10.1053/ejvs.1999.1028.

  PMID: 10753690 BACKGROUND

• Morris RJ, Woodcock JP. Effects of supine intermittent compression on arterial inflow to the lower limb. Arch Surg. 2002 Nov;137(11):1269-73. doi: 10.1001/archsurg.137.11.1269.

  PMID: 12413316 BACKGROUND

• Agu O, Baker D, Seifalian AM. Effect of graduated compression stockings on limb oxygenation and venous function during exercise in patients with venous insufficiency. Vascular. 2004 Jan;12(1):69-76. doi: 10.1258/rsmvasc.12.1.69.

  PMID: 15127858 BACKGROUND

• Junger M, Steins A, Hahn M, Hafner HM. Microcirculatory dysfunction in chronic venous insufficiency (CVI). Microcirculation. 2000;7(6 Pt 2):S3-12.

  PMID: 11151969 BACKGROUND

• Morris RJ, Woodcock JP. Intermittent venous compression, and the duration of hyperaemia in the common femoral artery. Clin Physiol Funct Imaging. 2004 Jul;24(4):237-42. doi: 10.1111/j.1475-097X.2004.00556.x.

  PMID: 15233839 BACKGROUND

• Sandberg M, Zhang Q, Styf J, Gerdle B, Lindberg LG. Non-invasive monitoring of muscle blood perfusion by photoplethysmography: evaluation of a new application. Acta Physiol Scand. 2005 Apr;183(4):335-43. doi: 10.1111/j.1365-201X.2005.01412.x.

  PMID: 15799770 BACKGROUND

• Zhang Q, Lindberg LG, Kadefors R, Styf J. A non-invasive measure of changes in blood flow in the human anterior tibial muscle. Eur J Appl Physiol. 2001 May;84(5):448-52. doi: 10.1007/s004210100413.

  PMID: 11417434 BACKGROUND

• Hanna GB, Newton DJ, Harrison DK, Belch JJ, McCollum PT. Use of lightguide spectrophotometry to quantify skin oxygenation in a variable model of venous hypertension. Br J Surg. 1995 Oct;82(10):1352-6. doi: 10.1002/bjs.1800821018.

  PMID: 7489162 BACKGROUND

• Zhang Q, Styf J, Lindberg LG. Effects of limb elevation and increased intramuscular pressure on human tibialis anterior muscle blood flow. Eur J Appl Physiol. 2001 Oct;85(6):567-71. doi: 10.1007/s004210100496.

  PMID: 11718286 BACKGROUND

• Reneman RS, Slaaf DW, Lindbom L, Tangelder GJ, Arfors KE. Muscle blood flow disturbances produced by simultaneously elevated venous and total muscle tissue pressure. Microvasc Res. 1980 Nov;20(3):307-18. doi: 10.1016/0026-2862(80)90031-x. No abstract available.

  PMID: 7207224 BACKGROUND

• Nielsen HV. Effects of externally applied compression on blood flow in subcutaneous and muscle tissue in the human supine leg. Clin Physiol. 1982 Dec;2(6):447-57. doi: 10.1111/j.1475-097x.1982.tb00051.x.

  PMID: 6891301 BACKGROUND

• Nielsen HV. External pressure--blood flow relations during limb compression in man. Acta Physiol Scand. 1983 Nov;119(3):253-60. doi: 10.1111/j.1748-1716.1983.tb07335.x.

  PMID: 6659990 BACKGROUND

• Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995 Apr;21(4):635-45. doi: 10.1016/s0741-5214(95)70195-8.

  PMID: 7707568 BACKGROUND

• Dinh T, Veves A. Microcirculation of the diabetic foot. Curr Pharm Des. 2005;11(18):2301-9. doi: 10.2174/1381612054367328.

  PMID: 16022669 BACKGROUND

• Bochmann RP, Seibel W, Haase E, Hietschold V, Rodel H, Deussen A. External compression increases forearm perfusion. J Appl Physiol (1985). 2005 Dec;99(6):2337-44. doi: 10.1152/japplphysiol.00965.2004. Epub 2005 Aug 4.

  PMID: 16081618 BACKGROUND

• Mateus J, Hargens AR. Photoplethysmography for non-invasive in vivo measurement of bone hemodynamics. Physiol Meas. 2012 Jun;33(6):1027-42. doi: 10.1088/0967-3334/33/6/1027. Epub 2012 May 4.

  PMID: 22562998 BACKGROUND

• Mateus J, Hargens AR. Bone hemodynamic responses to changes in external pressure. Bone. 2013 Feb;52(2):604-10. doi: 10.1016/j.bone.2012.11.010. Epub 2012 Nov 17.

  PMID: 23168293 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alan R Hargens, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 5, 2013
• Study Start: May 1, 2005
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (1)