Article | Published:

Intermittent mild negative pressure applied to the lower limb in patients with spinal cord injury and chronic lower limb ulcers: a crossover pilot study

Spinal Cordvolume 56pages372381 (2018) | Download Citation

Abstract

Study design

Randomized, assessor-blinded crossover pilot study.

Objectives

To explore the use of an intermittent negative pressure (INP) device for home use in addition to standard wound care (SWC) for patients with spinal cord injury (SCI) and chronic leg and foot ulcers before conducting a superiority trial.

Setting

Patient homes and outpatient clinic.

Methods

A 16-week crossover trial on 9 SCI patients (median age: 57 years, interquartile range [IQR] 52–66), with leg ulcers for 52 of weeks (IQR: 12–82) duration. At baseline, patients were allocated to treatment with INP + SWC or SWC alone. After 8 weeks, the ulcers were evaluated. To assess protocol adherence, the patients were then crossed over to the other group and were evaluated again after another 8 weeks. Lower limb INP treatment consisted of an airtight pressure chamber connected to an INP generator (alternating 10 s −40mmHg/7 s atmospheric pressure) used 2 h/day at home. Ulcer healing was assessed using a photographic wound assessment tool (PWAT) and by measuring changes in wound surface area (WSA).

Results

Seven of nine recruited patients adhered to a median of 90% (IQR: 80–96) of the prescribed 8-week INP-protocol, and completed the study without side effects. PWAT improvement was observed in 4/4 patients for INP + SWC vs. 2/5 patients for SWC alone (P = 0.13). WSA improved in 3/4 patients allocated to INP + SWC vs. 3/5 patients in SWC alone (P = 0.72).

Conclusions

INP can be used as a home-based treatment for patients with SCI, and its efficacy should be tested in an adequately sized, preferably multicenter randomized trial.

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References

  1. 1.

    Byrne DW, Salzberg CA. Major risk factors for pressure ulcers in the spinal cord disabled: a literature review. Spinal Cord. 1996;34:255–63.

  2. 2.

    Teasell RW, Arnold JM, Krassioukov A, Delaney GA. Cardiovascular consequences of loss of supraspinal control of the sympathetic nervous system after spinal cord injury. Arch Phys Med Rehabil. 2000;81:506–16.

  3. 3.

    Deitrick G, Charalel J, Bauman W, Tuckman J. Reduced arterial circulation to the legs in spinal cord injury as a cause of skin breakdown lesions. Angiology. 2007;58:175–84.

  4. 4.

    Schreml S, Szeimies RM, Prantl L, Karrer S, Landthaler M, Babilas P. Oxygen in acute and chronic wound healing. Br J Dermatol. 2010;163:257–68.

  5. 5.

    Hopman MT, Groothuis JT, Flendrie M, Gerrits KH, Houtman S. Increased vascular resistance in paralyzed legs after spinal cord injury is reversible by training. J Appl Physiol. 2002;93:1966–72.

  6. 6.

    Hopman MT, Nommensen E, van Asten WN, Oeseburg B, Binkhorst RA. Properties of the venous vascular system in the lower extremities of individuals with paraplegia. Paraplegia. 1994;32:810–6.

  7. 7.

    Hopman MT, van Asten WN, Oeseburg B. Changes in blood flow in the common femoral artery related to inactivity and muscle atrophy in individuals with long-standing paraplegia. Adv Exp Med Biol. 1996;388:379–83.

  8. 8.

    Gerrits HL, de Haan A, Sargeant AJ, van Langen H, Hopman MT. Peripheral vascular changes after electrically stimulated cycle training in people with spinal cord injury. Arch Phys Med Rehabil. 2001;82:832–9.

  9. 9.

    Smyth CN. Effect of suction on blood-flow in ischaemic limbs. Lancet. 1969;2:657–9.

  10. 10.

    Gill BS, Walder DN. Proceedings: the effect of intermittent suction on limb blood flow in peripheral vascular disease. Br J Surg. 1974;61:319.

  11. 11.

    Sundby ØH, Høiseth LØ, Mathiesen I, Jørgensen JJ, Sundhagen JO, Hisdal J. The effects of intermittent negative pressure on the lower extremities’ peripheral circulation and wound healing in four patients with lower limb ischemia and hard-to-heal leg ulcers: a case report. Physiol Rep. 2016;4:e12998.

  12. 12.

    Sundby ØH, Høiseth LØ, Mathiesen I, Jørgensen JJ, Weedon-Fekjær H, Hisdal J. Application of intermittent negative pressure on the lower extremity and its effect on macro and microcirculation in the foot of healthy volunteers. Physiol Rep. 2016;4:e12911.

  13. 13.

    Sundby ØH, Høiseth LØ, Mathiesen I, Weedon-Fekjær H, Sundhagen JO, Hisdal J. The acute effects of lower limb intermittent negative pressure on foot macro- and microcirculation in patients with peripheral arterial disease. PLoS ONE. 2017;12:e0179001.

  14. 14.

    Sundby ØH, Hoiseth LØ, Irgens I, Mathiesen I, Lundgaard E, Haugland H et al. Intermittent negative pressure applied to the lower limb increases foot macrocirculatory and microcirculatory blood flow pulsatility in people with spinal cord injury. Spinal Cord. 2017. https://doi.org/10.1038/s41393-017-0049-8.

  15. 15.

    Caro CG, Foley TH, Sudlow MF. Early effects of abrupt reduction of local pressure on the forearm and its circulation. J Physiol. 1968;194:645–58.

  16. 16.

    Rein EB, Filtvedt M, Walloe L, Raeder JC. Hypothermia during laparotomy can be prevented by locally applied warm water and pulsating negative pressure. Br J Anaesth. 2007;98:331–6.

  17. 17.

    Thompson N, Gordey L, Bowles H, Parslow N, Houghton P. Reliability and validity of the revised photographic wound assessment tool on digital images taken of various types of chronic wounds. Adv Skin Wound Care. 2013;26:360–73.

  18. 18.

    Maynard FM Jr, Bracken MB, Creasey G, Ditunno JF Jr, Donovan WH, Ducker TB, et al. International Standards for Neurological and Functional Classification of Spinal Cord Injury. American Spinal Injury Association. Spinal Cord. 1997;35:266–74.

  19. 19.

    Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20:187–91. discussion 191-3.

  20. 20.

    Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, et al. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012;126:2890–909.

  21. 21.

    Bø E, Hisdal J, Cvancarova M, Stranden E, Jorgensen JJ, Sandbaek G, et al. Twelve-months follow-up of supervised exercise after percutaneous transluminal angioplasty for intermittent claudication: a randomised clinical trial. Int J Environ Res Public Health. 2013;10:5998–6014.

  22. 22.

    Gould L, Stuntz M, Giovannelli M, Ahmad A, Aslam R, Mullen-Fortino M, et al. Wound Healing Society 2015 update on guidelines for pressure ulcers. Wound Repair Regen. 2016;24:145–62.

  23. 23.

    Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. 2016;24:136–44.

  24. 24.

    Federman DG, Ladiiznski B, Dardik A, Kelly M, Shapshak D, Ueno CM, et al. Wound Healing Society 2014 update on guidelines for arterial ulcers. Wound Repair Regen. 2016;24:127–35.

  25. 25.

    Rasband W, ImageJ US. National Institutes of Health. Maryland, USA: Bethesda; 1997; p. 1997–2007. http://imagej.nih.gov/ij/j-2016.

  26. 26.

    Dumville JC, Land L, Evans D, Peinemann F. Negative pressure wound therapy for treating leg ulcers. Cochrane Database Syst Rev 2015;Cd011354. https://doi.org/10.1002/14651858.CD011354.pub2.

  27. 27.

    Concepts K. VAC therapy: clinical guidelines. A reference source for clinicians. TX: San Antonio; 2010.

  28. 28.

    Skagen K, Henriksen O. Changes in subcutaneous blood flow during locally applied negative pressure to the skin. Acta Physiol Scand. 1983;117:411–4.

  29. 29.

    Lott ME, Hogeman C, Herr M, Bhagat M, Kunselman A, Sinoway LI. Vasoconstrictor responses in the upper and lower limbs to increases in transmural pressure. J Appl Physiol. 2009;106:302–10.

  30. 30.

    Suissa D, Danino A, Nikolis A. Negative-pressure therapy versus standard wound care: a meta-analysis of randomized trials. Plast Reconstr Surg. 2011;128:498e–503e.

  31. 31.

    Huang C, Leavitt T, Bayer LR, Orgill DP. Effect of negative pressure wound therapy on wound healing. Curr Probl Surg. 2014;51:301–31.

  32. 32.

    Houghton PE, Kincaid CB, Campbell KE, Woodbury MG, Keast DH. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy Wound Manag. 2000;46:20–6. 28-30

  33. 33.

    Houghton PE, Kincaid CB, Lovell M, Campbell KE, Keast DH, Woodbury MG, et al. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther. 2003;83:17–28.

  34. 34.

    Houghton PE, Campbell KE, Fraser CH, Harris C, Keast DH, Potter PJ, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. 2010;91:669–78.

  35. 35.

    Hopf HW, Hunt TK, West JM, Blomquist P, Goodson WH 3rd, Jensen JA, et al. Wound tissue oxygen tension predicts the risk of wound infection in surgical patients. Arch Surg. 1997;132:997–1004. discussion 1005

  36. 36.

    Himmelstrup H, Himmelstrup B, Mehlsen J, Trap-Jensen J. Effects of vacusac in intermittent claudication: a controlled cross-over study. Clin Physiol. 1991;11:263–9.

  37. 37.

    Mehlsen J, Himmelstrup H, Himmelstrup B, Winther K, Trap-Jensen J. Beneficial effects of intermittent suction and pressure treatment in intermittent claudication. Angiology. 1993;44:16–20.

  38. 38.

    Fife CE, Carter MJ. Wound care outcomes and associated cost among patients treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wound: a Compend Clin Res Pract. 2012;24:10–7.

  39. 39.

    Black J, Baharestani M, Cuddigan J, Dorner B, Edsberg L, Langemo D, et al. National Pressure Ulcer Advisory Panel’s updated pressure ulcer staging system. Urol Nurs. 2007;27:144–50. 156

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Acknowledgements

The authors would like to thank the patients for their participation in this study. We appreciate Otivio AS’ assistance in procuring laboratory probes, subatmospheric pressure chambers and INP pumps for use in the study. Thank you to Philip Bilberg for help with measurements in the clinical study. We would also like to thank Øystein Horgmo at the Medical Photography Section at the Institute of Clinical Medicine, University of Oslo, for help with the illustrations, and Annie Bersagel for language editing.

Funding

The Norwegian Research Council provided funding to Otivio (grant: 241589).

Author contributions

ØHS, LØH, and HW-F conceived of and designed the study. ØHS, II, HH, EL performed the experiments. ØHS, LØ, HW-F, JH, II, and HH, analyzed the data; ØHS, LØH, JH, and II interpreted the results of the experiments; ØHS, LØH, and JH prepared the figures; ØHS wrote the manuscript. All authors edited and critical reviewed the manuscript, and approved the final version of the manuscript.

Author information

Affiliations

  1. Section of Vascular Investigations, Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway

    • Øyvind Heiberg Sundby
    • , Lars Øivind Høiseth
    •  & Jonny Hisdal
  2. Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway

    • Øyvind Heiberg Sundby
    • , Ingebjørg Irgens
    •  & Gunnar Sandbæk
  3. Otivio AS, Gaustadalléen 21, 0349, Oslo, Norway

    • Øyvind Heiberg Sundby
    •  & Iacob Mathiesen
  4. Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway

    • Ingebjørg Irgens
    •  & Eivind Lundgaard
  5. Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

    • Lars Øivind Høiseth
  6. Department of Spinal Cord Injury, Sunnaas Rehabilitation Hospital, Oslo, Norway

    • Hanne Haugland
  7. Oslo Center for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway

    • Harald Weedon-Fekjær
  8. Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway

    • Jon O. Sundhagen
  9. Department of Radiology, Oslo University Hospital, Oslo, Norway

    • Gunnar Sandbæk

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Conflict of interest

The Research Council of Norway provided funding to Otivio (NFR grant no: 241589) for this study as part of an industrial PhD project. ØHS is a PhD student at the University of Oslo. ØHS is also employed at and is a shareholder in Otivio AS. Otivio AS owns and has the commercial rights to the intermittent negative pressure (INP) technology used in the study. IM is the Chief Scientific Officer and co-founder of Otivio AS, and is a shareholder in the company. None of the other authors have any personal conflicts of interest—financial or otherwise. The authors alone are responsible for the content and writing of the paper. Otivio has not had any role related to the design of the study, collection and analysis of data, or the decision to publish the results.

Corresponding author

Correspondence to Øyvind Heiberg Sundby.

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DOI

https://doi.org/10.1038/s41393-018-0080-4