A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

Armstrong, David G.; Orgill, Dennis P.; Glat, Paul M.; Galiano, Robert D.; Rasor, Zachary L; Isaac, Adam L; Carter, Marissa J.; Zelen, Charles M.

doi:10.1111/iwj.13932

Cited by 2 publications

(1 citation statement)

References 22 publications

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“…Armstrong et al. ( 55 ) present the ‘OptiPulse Active Therapy’ device - a ‘unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers’. They report that, in ten patients suffering grade 1 DFUs, eight out of ten wounds healed within twelve weeks of OptiPulse treatment.…”

Section: Resultsmentioning

confidence: 99%

Data-driven digital health technologies in the remote clinical care of diabetic foot ulcers: a scoping review

Lazarus,

Cioroianu,

Ehrhardt

et al. 2023

Front. Clin. Diabetes Healthc.

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BackgroundThe availability and effectiveness of Digital Health Technologies (DHTs) to support clinicians, empower patients, and generate economic savings for national healthcare systems are growing rapidly. Of particular promise is the capacity of DHTs to autonomously facilitate remote monitoring and treatment. Diabetic Foot Ulcers (DFUs) are characterised by high rates of infection, amputation, mortality, and healthcare costs. With clinical outcomes contingent on activities that can be readily monitored, DFUs present a promising focus for the application of remote DHTs.ObjectiveThis scoping review has been conducted as a first step toward ascertaining fthe data-related challenges and opportunities for the development of more comprehensive, integrated, and individualised sense/act DHTs. We review the latest developments in the application of DHTs to the remote care of DFUs. We cover the types of DHTs in development and their features, technological readiness, and scope of clinical testing.Eligibility criteriaOnly peer-reviewed original experimental and observational studies, case series and qualitative studies were included in literature searches. All reviews and manuscripts presenting pre-trial prototype technologies were excluded.MethodsAn initial search of three databases (Web of Science, MEDLINE, and Scopus) generated 1,925 English-language papers for screening. 388 papers were assessed as eligible for full-text screening by the review team. 81 manuscripts were found to meet the eligibility criteria.ResultsOnly 19% of studies incorporated multiple DHTs. We categorised 56% of studies as ‘Treatment-Manual’, i.e. studies involving technologies aimed at treatment requiring manual data generation, and 26% as ‘Prevention-Autonomous’, i.e. studies of technologies generating data autonomously through wearable sensors aimed at ulcer prevention through patient behavioural change. Only 10% of studies involved more ambitious ‘Treatment-Autonomous’ interventions. We found that studies generally reported high levels of patient adherence and satisfaction.ConclusionsOur findings point to a major potential role for DHTs in remote personalised medical management of DFUs. However, larger studies are required to assess their impact. Here, we see opportunities for developing much larger, more comprehensive, and integrated monitoring and decision support systems with the potential to address the disease in a more complete context by capturing and integrating data from multiple sources from subjective and objective measurements.

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Section: Resultsmentioning

confidence: 99%

Data-driven digital health technologies in the remote clinical care of diabetic foot ulcers: a scoping review

Lazarus,

Cioroianu,

Ehrhardt

et al. 2023

Front. Clin. Diabetes Healthc.

View full text Add to dashboard Cite

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A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

Armstrong

Orgill

Glat

et al. 2022

International Wound Journal

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The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with nonhealing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days (95% CI:24.3-58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.

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A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

Cited by 2 publications

References 22 publications

Data-driven digital health technologies in the remote clinical care of diabetic foot ulcers: a scoping review

Data-driven digital health technologies in the remote clinical care of diabetic foot ulcers: a scoping review

A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

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