Dataset Information

Association of sleep-disordered breathing and wound healing in patients with diabetic foot ulcers.

ABSTRACT:

Study objectives

Sleep-disordered breathing (SDB) is prevalent and associated with an increased risk of morbidity and mortality. However, whether SDB has an adverse impact on wound healing in patients with diabetic foot ulcers (DFUs) is uncertain. The purpose of this study was to investigate the association of SDB with wound healing in patients with DFUs.

Methods

A total of 167 patients with DFUs were enrolled between July 2013 and June 2019 at West China Hospital (Chengdu, China) to assess the association of SDB with wound healing, ulcer recurrence, and all-cause mortality.

Results

Whereas there was no significant association between apnea-hypopnea index (AHI) and wound healing, total sleep time (per hour: hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.01-1.30; P = .029), sleep efficiency (per 10%: HR, 1.20; 95% CI, 1.04-1.37; P = .012), and wakefulness after sleep onset (per 30 minutes: HR, 0.89; 95% CI, 0.82-0.97; P = .008) were associated with wound healing. Total sleep time (per hour: odds ratio, 0.71; 95% CI, 0.51-0.97; P = .035) and sleep efficiency (per 10%: odds ratio, 0.68; 95% CI, 0.47-0.97; P = .033) were also associated with ulcer recurrence. Mean oxygen saturation (per 3%: HR, 0.68; 95% CI, 0.49-0.94; P = .021) and percentage of sleep time with oxygen saturation < 90% (per 10%: HR, 1.25; 95% CI, 1.03-1.53; P = .026) were significantly associated with mortality.

Conclusions

SDB is highly prevalent in patients with DFUs but its severity, as conventionally measured by AHI, is not associated with wound healing. Sleep fragmentation and hypoxemia are stronger predictors of poor wound healing, high ulcer recurrence, and increased risk of death in patients with DFUs.

SUBMITTER: Chen L

PROVIDER: S-EPMC8320482 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

Association of sleep-disordered breathing and wound healing in patients with diabetic foot ulcers.

Chen Lihong L Ma Wanxia W Covassin Naima N Chen Dawei D Zha Panpan P Wang Chun C Gao Yun Y Tang Weiwei W Lei Fei F Tang Xiangdong X Ran Xingwu X

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20210501 5

<h4>Study objectives</h4>Sleep-disordered breathing (SDB) is prevalent and associated with an increased risk of morbidity and mortality. However, whether SDB has an adverse impact on wound healing in patients with diabetic foot ulcers (DFUs) is uncertain. The purpose of this study was to investigate the association of SDB with wound healing in patients with DFUs.<h4>Methods</h4>A total of 167 patients with DFUs were enrolled between July 2013 and June 2019 at West China Hospital (Chengdu, China) ...[more]

PMID: 33382033

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Project description:ImportanceDelayed healing of diabetic foot ulcers (DFUs) is known to be caused by dysregulated M1/M2-type macrophages, and restoring the balance between these macrophage types plays a critical role in healing. However, drugs used to regulate M1/M2 macrophages have not yet been studied in large randomized clinical trials.ObjectiveTo compare the topical application of ON101 cream with use of an absorbent dressing (Hydrofiber; ConvaTec Ltd) when treating DFUs.Design, setting, and participantsThis multicenter, evaluator-blinded, phase 3 randomized clinical trial was performed in 21 clinical and medical centers across the US, China, and Taiwan from November 23, 2012, to May 11, 2020. Eligible patients with debrided DFUs of 1 to 25 cm2 present for at least 4 weeks and with Wagner grade 1 or 2 were randomized 1:1 to receive ON101 or control absorbent dressings.InterventionsTwice-daily applications of ON101 or a absorbent dressing changed once daily or 2 to 3 times a week for 16 weeks, with a 12-week follow-up.Main outcomes and measuresThe primary outcome was the incidence of complete healing, defined as complete re-epithelialization at 2 consecutive visits during the treatment period assessed on the full-analysis set (FAS) of all participants with postrandomization data collected. Safety outcomes included assessment of the incidences of adverse events, clinical laboratory values, and vital signs.ResultsIn the FAS, 236 eligible patients (175 men [74.2%]; mean [SD] age, 57.0 [10.9] years; mean [SD] glycated hemoglobin level, 8.1% [1.6%]) with DFUs classified as Wagner grade 1 or 2 (mean [SD] ulcer area, 4.8 [4.4] cm2) were randomized to receive either the ON101 cream (n = 122) or the absorbent dressing (n = 114) for as long as 16 weeks. The incidence of complete healing in the FAS included 74 patients (60.7%) in the ON101 group and 40 (35.1%) in the comparator group during the 16-week treatment period (difference, 25.6 percentage points; odds ratio, 2.84; 95% CI, 1.66-4.84; P < .001). A total of 7 (5.7%) treatment-emergent adverse events occurred in the ON101 group vs 5 (4.4%) in the comparator group. No treatment-related serious adverse events occurred in the ON101 group vs 1 (0.9%) in the comparator group.Conclusions and relevanceIn this multicenter randomized clinical trial, ON101 exhibited better healing efficacy than absorbent dressing alone in the treatment of DFUs and showed consistent efficacy among all patients, including those with DFU-related risk factors (glycated hemoglobin level, ≥9%; ulcer area, >5 cm2; and DFU duration, ≥6 months).Trial registrationClinicalTrials.gov Identifier: NCT01898923.

Dataset Information

Association of sleep-disordered breathing and wound healing in patients with diabetic foot ulcers.

Study objectives

Methods

Results

Conclusions

Publications

Association of sleep-disordered breathing and wound healing in patients with diabetic foot ulcers.

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