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Remote Ischemic Conditioning for Treatment of Chronic Wounds

Primary Purpose

Leg Ulcer, Varicose Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Remote Ischemic Conditioning
Control
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer focused on measuring chronic ulcer, diabetic ulcer, venous ulcer, remote ischemic conditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:All patients presented to Chronic/Hard to heal wound clinic at Soroka University medical center and Sherutei Briut Clalit regional clinic.

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

Exclusion Criteria:Ulcers suspected or proven to be malignant tumors. Patients that are planned for vascular intervention within the next month Patients that are planned for amputation within the next month

Sites / Locations

  • Soroka University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIC

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wound Healing
Wound closure

Secondary Outcome Measures

Granulation
Change of granulation of wound according to granulation scale
Wound rea change
Change in % of wound area

Full Information

First Posted
August 17, 2016
Last Updated
August 17, 2016
Sponsor
Soroka University Medical Center
Collaborators
Sherutei Briut Clalit
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1. Study Identification

Unique Protocol Identification Number
NCT02873728
Brief Title
Remote Ischemic Conditioning for Treatment of Chronic Wounds
Official Title
Remote Ischemic Conditioning for Treatment of Chronic Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
Collaborators
Sherutei Briut Clalit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After getting patients informed consent. Initial evaluation that includes: Venous and Arterial vascular evaluation, Medical past History including medications and surgeries Documentation of the chronic wounds by description and photography with scale. Base line blood test for CBC, HbA1C, Electrolytes, Urea, Cr, Liver enzymes. IL 1 IL 6 VEGF NO CD34 Adenosine All patients will received the standard wound care in use by the staff of the chronic wound clinic. Care givers will be blinded as to the study allocation of each patient. Patients will be divided randomly into two equal groups. Pressure cuffs will be applied to both arms of all subjects. The cuffs will be inflated and deflated intermittently for three cycles of 5 minutes each. In the study group, the cuffs will be inflated to 50 mmHg above systolic blood pressure while the performing investigator examines the radial pulse to ensure complete blood flow obstruction. In the control group, inflation will be up to 10 mmHg only. The patients will be followed for 10 weeks. During this period, they will be examined every 2 weeks (5 follow-up visits); and in each of these visits the above procedure will be repeated including blood collection before intervention and 24-48h after intervention. In each visit a "blinded" physician will photograph with scale the wound and grade the granulation tissue covering the wound on a scale from 0 to 5. The primary end point of the study is the number of healed wounds and wound area change among the two groups. Secondary outcomes will be the degree of granulation tissue and levels of IL 1 IL 6 VEGF NO CD34 Adenosine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer, Varicose Ulcer
Keywords
chronic ulcer, diabetic ulcer, venous ulcer, remote ischemic conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Conditioning
Intervention Description
Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min
Primary Outcome Measure Information:
Title
Wound Healing
Description
Wound closure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Granulation
Description
Change of granulation of wound according to granulation scale
Time Frame
8 weeks
Title
Wound rea change
Description
Change in % of wound area
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
Levels of IL 1 IL6 VEGF, NCD34, Adenosine
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:All patients presented to Chronic/Hard to heal wound clinic at Soroka University medical center and Sherutei Briut Clalit regional clinic. Wound that did not heal under proper medical care for over two months. Exclusion Criteria:Ulcers suspected or proven to be malignant tumors. Patients that are planned for vascular intervention within the next month Patients that are planned for amputation within the next month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eldad Silberstein, MD
Phone
+972-8-6400880
Email
eldads@bgu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
David Czeiger, MD
Phone
+972-8-6400250
Email
czeiger@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eldad Silberstein, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Remote Ischemic Conditioning for Treatment of Chronic Wounds

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