Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment
Abstract:The aim of this study is to ascertain whether the simultaneous measurement of hemoglobin O2 saturation (StO2) and dimension of venous leg ulcers (VLU) by near infrared spectroscopy (NIRS) imaging can predict the healing course with protocols employing a conventional treatment alone or in combination with hyperbaric oxygen therapy (HBOT). NIRS 2D images of wound region were obtained in 81 patients with hard‐to‐heal VLU that had been assigned, in a randomized controlled clinical trial, to the following protocols… Show more
“…Longobardi et al ( 31 ) compared two different regimes of HBOT, namely twice a day for 3 weeks or once daily for 6 weeks, with standard treatment in a group of 81 patients with hard to heal venous ulcers. Healing was defined as a minimum wound area reduction of 40% and was highest in the 6-week HBOT group, and lowest in the 3-week HBOT group.…”
Background: Venous leg ulcers (VLUs) are common and have a large impact on healthcare budgets worldwide. Hyperbaric oxygen therapy (HBOT) may improve healing of these ulcers.Methods: Retrospective, single-center cohort study between 2013 and 2019. All patients with a VLU from an outpatient clinic providing HBOT and wound care were included. The primary outcome measure was wound healing, determined at discharge from the center. Other outcome measures were improvement in patient related outcome measures (PROMs), as assessed by the EQ-5D-3L questionnaire and including quality of life (QoL) and pain score.Results: Fifty patients were included, 53% female, with a mean age of 73.4 (±12.2). Most wounds (83%) had existed longer than 3 months before starting treatment. Patients received an average of 43 (±20) sessions of HBOT. After treatment, 37 patients (63%) achieved complete or near-complete wound healing. Wound size decreased from a median of 14 cm2 [interquartile range (IQR) 32 cm2] to 0.5 cm2 (IQR 5.3 cm2), a median decrease of 7.5 (IQR 16.2 cm2) in cm2 (94%). Patients mostly reported improvement for all health aspects on the questionnaire. Pain score decreased from 5.7 (±2.5) to 2.1 (±2.2) (p < 0.0001) and health score increased from 57.2 (±15.6) to 69.9 (±18.9) (p = 0.02).Conclusions: Patients with non-healing VLUs may benefit from HBOT to achieve complete or substantial wound healing. We recommend a well-designed randomized clinical trial with a number of patients allowing enough statistical power, and of a reasonable duration, to establish the potential of additional HBOT on hard-to-heal venous ulcers.
“…Longobardi et al ( 31 ) compared two different regimes of HBOT, namely twice a day for 3 weeks or once daily for 6 weeks, with standard treatment in a group of 81 patients with hard to heal venous ulcers. Healing was defined as a minimum wound area reduction of 40% and was highest in the 6-week HBOT group, and lowest in the 3-week HBOT group.…”
Background: Venous leg ulcers (VLUs) are common and have a large impact on healthcare budgets worldwide. Hyperbaric oxygen therapy (HBOT) may improve healing of these ulcers.Methods: Retrospective, single-center cohort study between 2013 and 2019. All patients with a VLU from an outpatient clinic providing HBOT and wound care were included. The primary outcome measure was wound healing, determined at discharge from the center. Other outcome measures were improvement in patient related outcome measures (PROMs), as assessed by the EQ-5D-3L questionnaire and including quality of life (QoL) and pain score.Results: Fifty patients were included, 53% female, with a mean age of 73.4 (±12.2). Most wounds (83%) had existed longer than 3 months before starting treatment. Patients received an average of 43 (±20) sessions of HBOT. After treatment, 37 patients (63%) achieved complete or near-complete wound healing. Wound size decreased from a median of 14 cm2 [interquartile range (IQR) 32 cm2] to 0.5 cm2 (IQR 5.3 cm2), a median decrease of 7.5 (IQR 16.2 cm2) in cm2 (94%). Patients mostly reported improvement for all health aspects on the questionnaire. Pain score decreased from 5.7 (±2.5) to 2.1 (±2.2) (p < 0.0001) and health score increased from 57.2 (±15.6) to 69.9 (±18.9) (p = 0.02).Conclusions: Patients with non-healing VLUs may benefit from HBOT to achieve complete or substantial wound healing. We recommend a well-designed randomized clinical trial with a number of patients allowing enough statistical power, and of a reasonable duration, to establish the potential of additional HBOT on hard-to-heal venous ulcers.
“…5 studies were identified for inclusion. 11-15 Figure 1 illustrates a flow diagram of this process.Figure 1.PRISMA flow diagram charting the literature search.…”
Background The use of Hyperbaric Oxygen Therapy (HBOT) in diabetic wounds has been studied extensively. Even though venous insufficiency is the most common cause of lower limb ulceration, there is comparatively little evidence regarding the use of HBOT for Venous Leg Ulcers (VLU). We performed a systematic-review to evaluate and synthesise available evidence, to evaluate whether patients with VLU, when treated with HBOT, had greater rates of (i) complete VLU healing or (ii) reduction in VLU area, than controls. Methods In keeping with PRISMA guidelines, database searches of PubMed, Scopus and Embase was performed. After removal of duplicates, titles were screened for relevance by two authors, then abstracts, and in turn full text manuscripts. Data were extracted from relevant sources including one published abstract. Included studies were assessed for risk of bias using the Risk of Bias 2 (RoB-2) and Risk Of Bias In Nonrandomized Studies (ROBINS-I) tools. Results Six studies were included. There was significant heterogeneity across the studies, with no standard control intervention, method of outcome reporting, or duration of follow up. Two studies reported 12 week follow up results and pooled analysis of complete ulcer healing showed no statistically significant difference between HBOT and controls for the outcome of complete ulcer healing OR 1.54 (95%CI = .50-4.75) P = .4478. A similar non-signifiacnt result was seen in four studies reporting 5-6 week follow up; OR 5.39 (95%CI = .57-259.57) P = .1136. Change in VLU area was reported in all studies, and pooled standardised mean difference was 1.70 (95%CI = .60 to 2.79) P = .0024, indicating a statistically significant benefit of HBOT in reducing ulcer area. Conclusion Existing evidence suggests that HBOT does not significantly affect complete healing of VLU. There is a statistically significant benefit in terms of reducing ulcer size, though in the absence of ulcer healing the clinical significance of this is not established. Current evidence does not justify widespread use of HBOT for VLU.
“…Longobardi et al reported a reduced healing rate when 2.4 ATA, 66 min, twice a day were used, which is higher pressure and more frequent use of HBOT compared with those of our protocol. 8) This result was possibly related to too much oxygen toxicity. Further pieces of evidence are necessary to elucidate the selection of appropriate candidates and modes of HBOT in future studies.…”
Section: Discussionmentioning
confidence: 99%
“…Two recent prospective trials failed to demonstrate the superiority of HBOT in terms of healing rate when compared with placebo or standard treatment. 7 , 8 ) These trials included VLUs that responded poorly to a 4 week standard treatment. By contrast, Bass reported that 15 of 19 VLUs, which had not healed for a median of 10.1 years, healed after a median of 60.7 (10–200) h of HBOT.…”
We report five cases of venous leg ulcers (VLU) that were resistant to conservative therapy for 22-119 months and were eventually healed via hyperbaric oxygen therapy (HBOT). In one patient, VLU recurred four times and was managed using HBOT, each time. The VLU sizes ranged from 18 to 68 cm 2 before HBOT. HBOT was administered at 2.0 atmospheres absolute with 100% oxygen for 60 min per session, five sessions a week during hospitalization. All VLUs healed after 17-66 sessions of HBOT.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
