NCT02873728

Brief Summary

The goals of this series of studies is to test the effect of RIC on chronic leg ulcers (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 17, 2016

Last Update Submit

August 17, 2016

Conditions

Leg UlcerVaricose Ulcer

Keywords

chronic ulcerdiabetic ulcervenous ulcerremote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

  • Wound Healing

    Wound closure

    8 weeks

Secondary Outcomes (2)

  • Granulation

    8 weeks

  • Wound rea change

    8 weeks

Other Outcomes (1)

  • Biomarkers

    8 weeks

Study Arms (2)

RIC

EXPERIMENTAL

In the study group, a blood pressure cuff will be inflated to 50 mmHg above systolic blood pressure while the performing investigator examines the radial pulse to ensure complete blood flow obstruction. Ischemia will be performed for 3 cycles of 5 min each and 10 min resting between cycles.

Procedure: Remote Ischemic Conditioning

Control

SHAM COMPARATOR

In the control group, a blood pressure cuff will be inflated to 10 mmHg (Sham procedure) for 3 cycles of 5 min each and 10 min resting between cycles.

Other: Control

Interventions

Remote Ischemic ConditioningPROCEDURE

Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff

RIC
ControlOTHER

Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Wound that did not heal under proper medical care for over two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Leg UlcerVaricose Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose VeinsVascular DiseasesCardiovascular Diseases

Study Officials

  • Eldad Silberstein, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eldad Silberstein, MD

CONTACT

+972-8-6400880eldads@bgu.ac.il

David Czeiger, MD

CONTACT

+972-8-6400250czeiger@bgu.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 19, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

February 1, 2019

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

IL(1)