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

NCT07291817 | Recruiting

• 1 other identifier: 2024-4641
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• Change in toe arterial pressure

  Toe systolic blood pressure is a commonly used tool to predict wound healing in patients with diabetic foot ulcers. * Tools used: Photoplethysmography (PPG) Probe/Sensor * Unit of measure: mmHg

  12 weeks

• Change in wound surface area

  Change in wound surface area will be used as an indicator of treatment effect on wound healing. * Tool used: quantitative measurement of wound surface area * Unit of measure: cm2

  12 weeks

Secondary Outcomes (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

  12 weeks

• Frequency of adverse events

  12 weeks

• Compliance (mean daily treatment time)

  12 weeks

Study Arms (1)

Treatment with FlowOx

EXPERIMENTAL

Device: FlowOx

Interventions

FlowOx DEVICE

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

Treatment with FlowOx

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<70 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

You may not qualify if:

• Known allergic reactions to components of the INP device.
• Pregnant women or cognitively impaired participants.

Sponsors & Collaborators

• Lo Zhiwen Joseph: lead
• Otivio AS: collaborator

Study Sites (1)

Woodlands Health

Singapore, Singapore

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Sinkowitz S, Gottlieb I. Thrombo-angiitis obliterans the conservative treatment by Bier's hyperemia suction apparatus. JAMA.1917;LXVIII(13):961-963.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Hoel H, Hoiseth LO, Sandbaek G, Sundhagen JO, Mathiesen I, Hisdal J. The acute effects of different levels of intermittent negative pressure on peripheral circulation in patients with peripheral artery disease. Physiol Rep. 2019 Oct;7(20):e14241. doi: 10.14814/phy2.14241.

  PMID: 31631579 BACKGROUND

• Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.

  PMID: 17093942 BACKGROUND

• Petersen BJ, Linde-Zwirble WT, Tan TW, Rothenberg GM, Salgado SJ, Bloom JD, Armstrong DG. Higher rates of all-cause mortality and resource utilization during episodes-of-care for diabetic foot ulceration. Diabetes Res Clin Pract. 2022 Feb;184:109182. doi: 10.1016/j.diabres.2021.109182. Epub 2022 Jan 18.

  PMID: 35063288 BACKGROUND

• Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

  PMID: 28614678 BACKGROUND

• Zhang Y, Lazzarini PA, McPhail SM, van Netten JJ, Armstrong DG, Pacella RE. Global Disability Burdens of Diabetes-Related Lower-Extremity Complications in 1990 and 2016. Diabetes Care. 2020 May;43(5):964-974. doi: 10.2337/dc19-1614. Epub 2020 Mar 5.

  PMID: 32139380 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Zhiwen Joseph Lo

  Woodlands Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 18, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)