Evidence map›Paper›PMID 39960153›Full record

Trial reportThe British journal of surgery2025

Decellularized dermis allograft for the treatment of venous leg ulceration: the DAVE RCT.

Sarah Onida, Matthew Tan, Valeria Balan, Francine Heatley, Sarrah Peerbux, Layla Bolton-Saghdaoui, Tristan Lane, David Epstein, Manjit Gohel, John Norrie and 3 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sarah OnidaSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.ORCID 0000-0001-5926-4578
Matthew TanSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.ORCID 0000-0002-5789-0353
Valeria BalanSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Francine HeatleySection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Sarrah PeerbuxSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Layla Bolton-SaghdaouiSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Tristan LaneSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.ORCID 0000-0002-8681-7075
David EpsteinDepartment of Applied Economics, University of Granada, Granada, Spain.
Manjit GohelCambridge Vascular Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
John NorrieEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
Robert LeeEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
Richard LomasTissue and Eye Services, National Health Service Blood and Transplant, Bristol, UK.
Alun H DaviesSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.ORCID 0000-0001-5261-6913

Funding

JP Moulton Charitable Trust 14/140/61
6 · The paper itself

Abstract

backgroundVenous leg ulcers (VLUs) cause significant impairment to patients' quality of life (QoL) and up to 30% do not heal at 6 months. Decellularized dermis (DCD) allografts have been shown to be effective in improving healing rates of diabetic foot ulcers in RCTs. The DAVE RCT aimed to determine whether DCD is an effective, safe, and cost-effective treatment adjunct for VLUs.

methodsThis was a multicentre RCT performed in the UK. Patients with lower limb ulcers ≥18 years with VLU, venous incompetence on duplex ultrasound, an ankle : brachial pressure index ≥ 0.8 and an index VLU present for at least 3 months and ≥2 cm2 in size were included. Patients were randomized to either the intervention (DCD graft and standard of care) or control arm (standard of care alone). The primary outcome was the proportion of patients with a healed index ulcer at 12 weeks.

resultsFrom October 2019 to October 2022, 36 and 35 participants were randomized into the intervention and control arms respectively. Patient characteristics at baseline were similar between groups. Healing was recorded in 5.7% of the intervention group and 15.2% in the control group (OR 0.34, 95% c.i. 0.03 to 2.31). There were no significant differences in the secondary outcomes including the percentage change in ulcer area, time to healing, recurrence rates, and QoL. There were five serious adverse events attributed to DCD application. Early trial termination was advised after the interim data analysis due to a lower-than-expected primary outcome rate (11.3%).

conclusionsDecellularized dermis grafts did not improve healing rates of venous leg ulcers, although the trial was terminated early due to poor healing rates in both the intervention and control arms. Important clinical benefits or harms of decellularized dermis grafts could not be excluded due to the small sample size.

trial registrationISRCTN 21541209.

Indexed as

DermisSkin TransplantationVaricose UlcerAgedAllograftsFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeWound Healing

Identifiers

PMID39960153
PMCPMC11831364

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.