Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study

Обзор

The aim of this trial is to investigate the safety and efficacy of 12 weeks treatment with FlowOx, for 1 hour twice daily, when used on patients with diabetic foot ulcers. The main question it aims to answer is whether treatment with FlowOx one hour in the morning and one hour in the evening for 12 weeks can improve toe arterial pressure and wound surface area compared to baseline. Participants will have baseline assessments (i.e. toe pressure measurement and wound area measurement) performed on them and training on the use of FlowOx device will be provided to them in Visit 1. Participants will be tasked to use the FlowOx device (device will be loaned to them) for 1 hour twice daily. A phone call will be conducted 1 week after Visit 1 to follow up on the medical and user-related issues. At Week 6 (Visit 2), participants will be asked to come back for toe pressure and wound area measurement. At Week 12 (Visit 3), end of treatment assessments (i.e toe pressure and wound area measurement) will be performed. Compliance data will be acquired from the FlowOx device. Their participation in the study will last for 12 weeks. Participants will be asked to use the FlowOx device for one hour, two times a day throughout the study period. They will need to visit the clinic 3 times in the course of the study.

Вмешательства

• Устройство FlowOx
  12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks

Первичные конечные точки

• Change in toe arterial pressure [Срок оценки: 12 weeks]
• Change in wound surface area [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Comparison of the primary outcomes (changes in toe arterial pressure and wound healing rate) and post diabetic limb salvage rate between a prospective cohort that is 1:1 propensity-scored matched against a retrospective cohort [Срок оценки: 12 weeks]
• Frequency of adverse events [Срок оценки: 12 weeks]
• Compliance (mean daily treatment time) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 21-99.
• Diagnosed with diabetes mellitus.
• Toe systolic pressure <90 mmHg on the leg to be treated (after revascularization)
• Open chronic wound on the foot
• Ability to operate the treatment device, and willing to adhere to the study intervention regimen.
• Suitable for diabetic limb salvage

Критерии исключения

• Known allergic reactions to components of the INP device.
• Treatment with another investigational intervention within the last 12 weeks prior to inclusion.
• Pregnant women or cognitively impaired participants.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Сингапур · 1 центр

• Woodlands Health — Singapore

Публикации

• Yagshyyev S, Hausmann P, Li Y, Kempf J, Zetzmann K, Dessi K, Moosmann O, Almasi-Sperling V, Meyer A, Gerken ALH, Lang W, Rother U. Intermittent negative pressure therapy in patients with no-option chronic limb-threatening ischemia. Vasa. 2023 Nov;52(6):402-408. doi: 10.1024/0301-1526/a001098. Epub 2023 Oct 17. PMID 37847243
• Herrmann LG, Reid MR. THE CONSERVATIVE TREATMENT OF ARTERIOSCLEROTIC PERIPHERAL VASCULAR DISEASES: PASSIVE VASCULAR EXERCISES (PAVAEX THERAPY). Ann Surg. 1934 Oct;100(4):750-60. doi: 10.1097/00000658-193410000-00016. No abstract available. PMID 17856393
• Landis E.M HLH. The clinical value of alternate suction and pressure in the treatment of advanced peripheral vascular disease. The American Journal of the Medical Sciences. 1935;189(3):20.
• Sinkowitz S, Gottlieb I. Thrombo-angiitis obliterans the conservative treatment by Bier's hyperemia suction apparatus. JAMA.1917;LXVIII(13):961-963.
• Sundby OH, Hoiseth LO, Mathiesen I, Jorgensen JJ, Sundhagen JO, Hisdal J. The effects of intermittent negative pressure on the lower extremities' peripheral circulation and wound healing in four patients with lower limb ischemia and hard-to-heal leg ulcers: a case report. Physiol Rep. 2016 Oct;4(20):e12998. doi: 10.14814/phy2.12998. PMID 27798353
• Sundby OH, Irgens I, Hoiseth LO, Mathiesen I, Lundgaard E, Haugland H, Weedon-Fekjaer H, Sundhagen JO, Sandbaek G, Hisdal J. Intermittent mild negative pressure applied to the lower limb in patients with spinal cord injury and chronic lower limb ulcers: a crossover pilot study. Spinal Cord. 2018 Apr;56(4):372-381. doi: 10.1038/s41393-018-0080-4. Epub 2018 Mar 1. PMID 29497177
• Hoel H, Pettersen EM, Hoiseth LO, Mathiesen I, Seternes A, Hisdal J. A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication. J Vasc Surg. 2021 May;73(5):1750-1758.e1. doi: 10.1016/j.jvs.2020.10.024. Epub 2020 Oct 22. PMID 33899743
• Sundby OH, Hoiseth LO, Mathiesen I, Weedon-Fekjaer H, Sundhagen JO, Hisdal J. The acute effects of lower limb intermittent negative pressure on foot macro- and microcirculation in patients with peripheral arterial disease. PLoS One. 2017 Jun 7;12(6):e0179001. doi: 10.1371/journal.pone.0179001. eCollection 2017. PMID 28591174

Идентификаторы

NCT: NCT07291817 · 2024-4641

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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