Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology.
Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
There are 6 studies summarised in this briefing, including a total of 121 people. Two studies are observational, 1 of which is a pilot study. Four are case series. Davies and Dunn (2021) is an extension to the Kettley and Turner-Dobbin study.
The company sponsored a consensus article on the benefits of intermittent pneumatic compression and how to use WoundExpress in practice.
The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.
Overall assessment of the evidence
The evidence base for the technology is of low methodological quality and the studies are small in terms of patient numbers. All studies are based in the UK and generalisable to clinical practice in the NHS. The observational studies both suggested that using WoundExpress could improve hard to heal wounds. Case series also showed reduced wound size and pain. Further evidence is needed from larger sample sizes with comparator arms and improved internal validity. Both observational studies received funding from Huntleigh Healthcare and the former company Arjo (now ArjoHuntleigh Healthcare).
Morris et al. (2020)
Study size, design and location
Prospective observational study of 33 people (including 20 healthy volunteers) in Wales.
Key outcomes
Measured the haemodynamic potential of a thigh-only approach to intermittent pneumatic compression. The average peak velocity caused by the intermittent compression was 11.6 cm/s, which was greater than for the previous group of healthy volunteers (Mann–Whitney U, p=0.1, 2‑tailed). The mean of the approximate correlate of the volume of venous blood (multiplication of the mean peak velocity and the mean duration of venous blood flow) was 8.2 cm, which was greater than for the healthy volunteers (Mann–Whitney U, p=0.3, 2‑tailed).
Strengths and limitations
The small number of patients and heterogenous disease conditions in the ulcer group make it difficult to draw firm conclusions. Scans were not available, so some differences in effect may have been caused by underlying vascular conditions. Arjo (now ArjoHuntleigh) provided funding to support the work.
Naik et al. 2019
Study size, design and location
Prospective observational pilot study of 21 patients in the UK.
Key outcomes
Wounds progressed towards healing in 20 patients, with the median wound area at 8 weeks post intervention significantly lower than at recruitment (Z=-3.980, p<0.000). Pain scores significantly reduced in 15 patients (Z=-2.905, p<0.036).
Strengths and limitations
This was the first pilot study of WoundExpress. The main limitation was that it was not a controlled study, with the potential for selection bias. Regression to mean bias is also not addressed, however the author argues that it is unlikely given the population of hard to heal wounds. Huntleigh Healthcare sponsored and funded the study.
Davies and Dunn 2021
Key outcomes
Fifty-three out of 61 participants completed the evaluations. Thirty-three per cent (n=19) of all ulcers healed within the 16‑week study period; the mean time to healing was 10 weeks. Sixty per cent of ulcers (n=35) progressed towards healing with a mean surface area reduction of 56% (23 cm2). Seven per cent (n=4) did not progress towards healing.
Strengths and limitations
Eight participants withdrew from the study and 5 were removed from the analysis. Without a control the progression towards healing cannot be attributed to WoundExpress. However the authors note that the population's hard to heal wounds had a mean duration of 50 months before entry into the study.
Kettley and Turner-Dobbin 2020
Study size, design and location
Case series abstract including 27 patients recruited across 6 sites in the UK.
Key outcomes
In Wales 8 out of 11 patients completed the 16‑week evaluation using WoundExpress. All 8 progressed towards healing, with a mean wound surface area reduction of 63%. In England 13 out of 16 patients completed the 16‑week evaluation with 12 progressing towards healing, with a mean surface area reduction of 66%. In England 2 patients' wounds had complete epithelisation and in Wales this was 5.
Ivins et al. 2020
Key outcomes
The first patient's wound surface area reduced by 71.5%, and their pain reduced by 65% after 4 months using WoundExpress. The second patient's pain score reduced from 5 to 4 out of 10 after 6 weeks. The wound completely healed at week 16 and the patient said they were no longer in pain.
Ivins et al. 2020
Sustainability
The company claims the technology could reduce environmental impact if patients have to travel less to appointments. There is no published evidence to support these claims.
Recent and ongoing studies
Intermittent pneumatic compression of the thigh for the treatment of lower limb wounds. Trial identifier: ISRCTN77093550. Status: recruiting to start March 2021. Indication: lower limb wounds. Devices: WoundExpress. Countries: Wales, England, Germany and Sweden.