Chuter V, Schaper N, Hinchliffe R, Mills J, Azuma N, Behrendt CA, Boyko EJ, Conte MS, Humphries M, Kirksey L, McGinigle KC, Nikol S, Nordanstig J, Rowe V, David R, van den Berg JC, Venermo M, Fitridge R, et al.
Diabetes/metabolism research and reviews. Date of publication 2023 Jul 26;volume ():e3701.
1. Diabetes Metab Res Rev. 2023 Jul 26:e3701. doi: 10.1002/dmrr.3701. Online
ahead of print.
Performance of non-invasive bedside vascular testing in the prediction of wound
healing or amputation among people with foot ulcers in diabetes: A systematic
review.
Chuter V(1), Schaper N(2), Hinchliffe R(3), Mills J(4), Azuma N(5), Behrendt
CA(6), Boyko EJ(7), Conte MS(8), Humphries M(9), Kirksey L(10), McGinigle
KC(11), Nikol S(12), Nordanstig J(13), Rowe V(14), David R(15), van den Berg
JC(16), Venermo M(17), Fitridge R(18)(19).
Author information:
(1)School of Health Sciences, Western Sydney University, Campbelltown, Sydney,
Australia.
(2)Division of Endocrinology, Department of Internal Medicine, MUMC+,
Maastricht, The Netherlands.
(3)Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.
(4)Baylor College of Medicine, Houston, Texas, USA.
(5)Asahikawa Medical University, Asahikawa, Hokkaido, Japan.
(6)Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbek,
Asklepios Medical School, Hamburg, Germany.
(7)University of Washington, Seattle, Washington, USA.
(8)San Francisco (UCSF) Medical Centre, University of California, San Francisco,
California, USA.
(9)UC Davis Medical Centre, Sacramento, California, USA.
(10)The Cleveland Clinic, Cleveland, Ohio, USA.
(11)University of North-Carolina, Chapel Hill, North Carolina, USA.
(12)Clinical and Interventional Angiology, Asklepios Klinik, St. Georg, Hamburg,
Germany.
(13)Sahlgrenska University Hospital, Gothenburg, Sweden.
(14)David Geffen School of Medicine, UCLA, Los Angeles, California, USA.
(15)Leeds Teaching Hospitals NHS Trust, Leeds, UK.
(16)CENTRO VASCOLARE TICINO Ospedale Regionale di Lugano, sede Civico and
Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische
Radiologie Inselspital, Universitätsspital, Bern, Switzerland.
(17)Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
(18)Faculty of Health and Medical Sciences, University of Adelaide, Adelaide,
South Australia, Australia.
(19)Vascular and Endovascular Service, Royal Adelaide Hospital, Adelaide, South
Australia, Australia.
INTRODUCTION: The presence of peripheral artery disease (PAD) confers a
significantly increased risk of failure to heal and major lower limb amputation
for people with diabetes-related foot ulcer (DFU). Determining performance of
non-invasive bedside tests for predicting likely DFU outcomes is therefore key
to effective risk stratification of patients with DFU and PAD to guide
management decisions. The aim of this systematic review was to determine the
performance of non-invasive bedside tests for PAD to predict DFU healing,
healing post-minor amputation, or need for minor or major amputation in people
with diabetes and DFU or gangrene.
METHODS: A database search of Medline and Embase was conducted from 1980 to 30
November 2022. Prospective studies that evaluated non-invasive bedside tests in
patients with diabetes, with and without PAD and foot ulceration or gangrene to
predict the outcomes of DFU healing, minor amputation, and major amputation with
or without revascularisation, were eligible. Included studies were required to
have a minimum 6-month follow-up period and report adequate data to calculate
the positive likelihood ratio (PLR) and negative likelihood ratio for the
outcomes of DFU healing, and minor and major amputation. Methodological quality
was assessed using the Quality in Prognosis Studies tool.
RESULTS: From 14,820 abstracts screened 28 prognostic studies met the inclusion
criteria. The prognostic tests evaluated by the studies included: ankle-brachial
index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4
studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7
studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal
waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic
velocity in 1 study. Study quality was variable. Common reasons for studies
having a moderate or high risk of bias were poorly described study
participation, attrition rates, and inadequate adjustment for confounders. In
people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion
pressure of ≥40 mmHg were associated with a moderate to large increase in
pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was
associated with a moderate increase in healing post-minor amputation. An ABI
using a threshold of ≥0.9 did not increase the pretest probability of DFU
healing, whereas an ABI <0.5 was associated with a moderate increase in pretest
probability of non-healing. Few studies investigated amputation outcomes. An ABI
<0.4 demonstrated the largest increase in pretest probability of a major
amputation (PLR ≥10).
CONCLUSIONS: Prognostic capacity of bedside testing for DFU healing and
amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin
perfusion pressure of ≥40 mmHg are associated with a moderate to large increase
in pretest probability of healing in people with DFU. There are little data
available evaluating the prognostic capacity of bedside testing for healing
after minor amputation or for major amputation in people with DFU. Current
evidence suggests that an ABI <0.4 may be associated with a large increase in
risk of major amputation. The findings of this systematic review need to be
interpreted in the context of limitations of available evidence, including
varying rates of revascularisation, lack of post-revascularisation bedside
testing, and heterogenous subpopulations.
© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John
Wiley & Sons Ltd.
DOI: 10.1002/dmrr.3701
PMID: 37493206
