Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Recent and ongoing studies

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 4 observational studies summarised in this briefing, involving 222 patients who used LQD Spray. Included studies were done in the UK and Germany. Two of the included studies used LQD Spray in slow or non-healing diabetic and venous ulcers. Another study used LQD Spray mainly in chronic wounds, but also included patients with post-operative wounds and burns. The most recent study included LQD Spray in patients with wounds secondary to self-harm. Outcomes were assessed by clinicians, but the exact settings (primary or secondary care) are not clearly documented.

Table 3 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The evidence for LQD Spray is limited in quality and quantity. Studies lack a comparator group, which makes it difficult to draw conclusions on the efficacy of LQD Spray compared with standard care. There is also limited evidence in patients with self-harm wounds.

Larger, UK-based multicentre randomised controlled trials comparing LQD Spray with standard of care should be done. These should include patients with chronic wounds, such as diabetic foot ulcers and venous leg ulcers, and patients with acute wounds, such as self-harm wounds. Follow up should be long enough to show wound healing or change in treatment regime if LQD Spray is not successful. Studies should use LQD Spray in a variety of settings, including primary care, secondary care (both inpatient and outpatient) and home settings. Blinding of clinicians may not be possible because of visual differences between LQD Spray and standard care.

Table 3 Summary of selected studies

Sharpe et al. (2018)
Study size, design and location	A multicentre observational study involving 35 patients with non-healing or slow-healing diabetic foot ulcers (n=11) or venous leg ulcers (n=24). Location: UK.
Intervention and comparator(s)	Intervention: LQD Spray (n=35). No comparator.
Key outcomes	In the venous leg ulcer patients, 13 healed completely, 11 showed a 75% wound area reduction and an increase in the percentage of healthy tissue. In diabetic foot ulcer patients, 5 patients healed, 4 patients made progress towards healing and 2 patients showed no change. No patients reported any clinical signs or symptoms of infection or biofilm formation. Patient and clinician reporting indicated LQD Spray had a 'positive impact' on wound progress. Costs calculated showed LQD Spray saved £3,771.75 and £1,492.19 in diabetic foot ulcer and venous leg ulcer groups respectively. The average treatment time saved was 117 days for diabetic foot ulcers.
Strengths and limitations	Study was based in UK so generalisable to NHS setting. The multicentre design at 4 clinical locations and use of the same clinical wound evaluation form increases reliability of results. No comparator so unable to compare results with standard care. LQD Spray was added to existing treatment regimens, so it is not possible to attribute wound healing solely to LQD Spray. Clinicians and patients were not blinded, introducing the risk of bias. There were 3 patients lost to follow up, but these patients were not accounted for and reasons for loss to follow up were not documented.
Hampton (2018)
Study size, design and location	An observational study involving 7 patients with slow-healing venous leg ulcers. Location: UK.
Intervention and comparator(s)	Intervention: LQD Spray. No comparator.
Key outcomes	Out of 7 patients, 4 patients' wounds healed (57%), with the remaining 3 patients showing reduced wound surface area. There were 7 patients with reduced frequency of dressing changes, from 2 to 1 dressing change per week in 6 patients and from 3 to 1 in the other patient. There were 6 patients who had an improvement in tissue type present in the wound, and 1 patient noted an increase in sloughy tissue. The calculated cost savings with LQD Spray were £3,535.
Strengths and limitations	Very small sample size limits reliability of results. The LQD Spray was used in addition to a pre-existing dressing regimen, making it difficult to attribute any healing solely to LQD Spray. Patient-reported outcomes are subject to bias and are subjective. Lack of statistical analysis of results. No comparator group makes it difficult to draw conclusions to standard care. Baseline characteristics not similar, so confounding factors not well controlled, for example, there was a large range of patient ages (17 to 88 years) and wound sizes (2.5 × 2 × 5 cm²to 6.1 × 6.1 × 37.21 cm²).
Widler et al. (2014)
Study size, design and location	A multicentre cohort study involving 173 patients with venous ulcers, diabetic foot syndrome, decubitus and other chronic wounds, post-operative disorders, burns and abscesses, and other indications from 15 medical practices and wound centres. Location: Germany.
Intervention and comparator(s)	Intervention: LQD Spray. No comparator.
Key outcomes	There were 173 patients (100%) who showed improvement in wound status, with 13 patients having complete healing. Pain decreased more than 90% with LQD Spray. Practitioners were 'satisfied' with LQD in 145 patients (83.8%), not satisfied in 15 patients (9.7%) and data were not available for 13 patients (7.5%). Wound size was evaluated in 171 patients, and decreased or became stable with LQD Spray in more than 94% of patients.
Strengths and limitations	Good sample size and multicentre study increases reliability of results. Range of outcomes considered including pain, wound size and healing. Unpublished, not a peer-reviewed study from company website, so is considered low-quality evidence. Study in Germany so may not be applicable to NHS setting. No statistical analysis of results. No comparator so unable to draw conclusions compared with standard care. Subjective reporting of practitioner satisfaction in addition to lack of blinding introduces risk of bias.
Hinchliffe and Linthwaite (2019)
Study size, design and location	A 2-centre evaluation involving 7 patients with wounds secondary to self-harm (n=3), neglect (n=2) and diabetes (n=2). Location: UK.
Intervention and comparator(s)	Intervention: LQD Spray. No comparator.
Key outcomes	All wounds healed within 3 weeks. The surrounding skin after LQD Spray was 'healthy' in 5 patients, and 'healed' in 2 patients. No wounds had any exudate following LQD Spray.
Strengths and limitations	Non-comparative study is low-quality evidence. Very small sample size limits reliability of results. No statistical analysis of results. No information on how skin healing was assessed, and whether this was consistent across the 2 sites.

Recent and ongoing studies

Ongoing research has been identified by the company, including in NHS hospitals and community settings in the UK. Therapy areas of research include patients with dementia, patients with ulcers, stoma sites, and burns.