NCT02622308

The Effects of INP on Peripheral Circulation in Dialysis Patients and Patients With PAD and Leg Ulcers

Terminated NA Last updated 6 April 2017

What this trial tests

NA trial testing FlowOx™ in Renal Disease in 4 participants. Terminated before completion.

Timeline

11 March 2016

Primary endpoint
11 April 2016

7 December 2016

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	11 March 2016
Primary completion	11 April 2016
Estimated completion	7 December 2016
Sites	1 location across Norway

Drugs / interventions tested

• FlowOx™

Conditions studied

• Renal Disease — all drugs for Renal Disease →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Arterial Leg Ulcers — all drugs for Arterial Leg Ulcers →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 96, any sex, with Renal Disease or Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment.

The hypothesis of the study is:

* Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment.
* Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical management of peripheral arterial disease in chronic kidney disease-a comprehensive review from the European Renal Association CKD-MBD Working Group.
   Huish S, Nawaz S, Bellasi A, Diaz-Tocados JM, et al · · 2025 · cited 4× · PMID 40599821 · DOI 10.1093/ckj/sfaf089