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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


Study design

Randomized, assessor-blinded crossover pilot study.


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.


Patient homes and outpatient clinic.


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).


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).


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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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.


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


  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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