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Remote Ischemic Conditioning in Patients With Ulcerative Colitis

NCT02445365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-03-22

No results posted yet for this study

Summary

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic tools.

This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is likely to involve suppressed inflammation and cell death.

Our study is a randomized clinical controlled study including 38 patients. Patients will receive RIC or sham for 10 consecutive days.

The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy findings, and various markers in the blood, faeces and the intestinal wall.

Conditions

  • Colitis, Ulcerative
  • Gastrointestinal Diseases
  • Pathologic Processes
  • Intestinal Diseases
  • Inflammatory Bowel Diseases

Interventions

DEVICE

AutoRIC device

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jens Kjeldsen, MD, PhD · Odense University Hospital

  • Line Godskesen · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-02-28
Completion
2018-02-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445365 on ClinicalTrials.gov