Wang HT, Yuan JQ, Zhang B, Dong ML, Mao C, Hu D, et al.
The Cochrane database of systematic reviews. Date of publication 2017 Jun 28;volume 6():CD011979.
1. Cochrane Database Syst Rev. 2017 Jun 28;6:CD011979. doi:
10.1002/14651858.CD011979.pub2.
Phototherapy for treating foot ulcers in people with diabetes.
Wang HT(1), Yuan JQ, Zhang B, Dong ML, Mao C, Hu D.
Author information:
(1)Burns Centre of PLA, Department of Burns and Cutaneous Surgery, Xijing
Hospital, Fourth Military Medical University, 169, Changle West Road, Xi'an,
Shanxi Province, China.
BACKGROUND: Foot ulcers are a disabling complication of diabetes that affect 15%
to 25% of people with diabetes at some time in their lives. Phototherapy is a
relatively new, non-invasive, and pain-free treatment method, which promotes the
ulcer repair process through multiple mechanisms such as increased cell growth
and vascular activity. Phototherapy may be used as an alternative approach for
the treatment of foot ulcers in people with diabetes, but the evidence for its
effect compared with placebo or other treatments has not yet been established.
OBJECTIVES: To assess the effects of phototherapy for the treatment of foot
ulcers in people with diabetes.
SEARCH METHODS: We searched the Cochrane Wounds Specialised Register (11 October
2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane
Library, 2016, Issue 10), Ovid MEDLINE (11 October 2016), Ovid MEDLINE
(In-Process & Other Non-Indexed Citations) (11 October 2016), Ovid Embase (11
October 2016), EBSCO CINAHL Plus (11 October 2016), and China National Knowledge
Infrastructure (24 June 2017). We also searched clinical trials registries for
ongoing and unpublished studies on 24 June 2017, and screened reference lists to
identify additional studies. We used no restrictions with respect to language,
date of publication, or study setting.
SELECTION CRITERIA: Randomised controlled trials or cluster randomised controlled
trials that 1) compared phototherapy with sham phototherapy, no phototherapy, or
other physical therapy modalities, 2) compared different forms of phototherapy,
or 3) compared phototherapy of different output power, wavelength, power density,
or dose range, in adults with diabetes and an open foot ulcer of any severity, in
any setting.
DATA COLLECTION AND ANALYSIS: Two review authors independently performed study
selection, data extraction, and 'Risk of bias' assessment. We combined the study
outcomes when appropriate.
MAIN RESULTS: Eight trials with 316 participants met the inclusion criteria. Most
of the included studies were single-centre studies that were carried out in
clinics or hospitals with a sample size ranging from 14 to 84. We generally
considered the included studies to be at unclear or high risk of bias, as they
had one domain at high risk of bias, or three or more domains at unclear risk of
bias.We did not identify any studies that reported valid data for time to
complete wound healing. Meta-analysis of four studies including 116 participants
indicated that participants receiving phototherapy may experience a greater
proportion of wounds completely healed during follow-up compared with those
receiving no phototherapy/placebo (64.5% for the phototherapy group versus 37.0%
for the no phototherapy/placebo group; risk ratio 1.57, 95% confidence interval
1.08 to 2.28; low-quality evidence, downgraded for study limitations and
imprecision). Two studies mentioned adverse events in the results; one study with
16 participants suggested that there were no device-related adverse events, and
the other study with 14 participants suggested that there was no clear difference
between phototherapy and placebo group.Four studies reported change in ulcer
size, but primarily due to high heterogeneity, they were not combined. Results
from individual trials (including 16 participants to 84 participants) generally
suggested that after two to four weeks of treatment phototherapy may result in a
greater reduction in ulcer size but the quality of the evidence was low due to
unclear risk of bias in the original trial and small sample size. We based the
analyses for quality of life and amputations on only one study each (28
participants and 23 participants respectively); both outcomes showed no clear
difference between the phototherapy group and the no phototherapy/placebo group.
AUTHORS' CONCLUSIONS: This systematic review of randomised trials suggested that
phototherapy, when compared to no phototherapy/placebo, may increase the
proportion of wounds completely healed during follow-up and may reduce wound size
in people with diabetes, but there was no evidence that phototherapy improves
quality of life. Due to the small sample size and methodological flaws in the
original trials, the quality of the evidence was low, which reduces our
confidence in these results. Large, well-designed randomised controlled trials
are needed to confirm whether phototherapy could be an effective option for the
treatment of foot ulcers in people with diabetes.
DOI: 10.1002/14651858.CD011979.pub2
PMID: 28657134 [Indexed for MEDLINE]
