Remote Ischemic Conditioning for Treatment of Chronic Wounds
NCT ID: NCT02873728
Last Updated: 2016-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-11-30
2019-02-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RIC
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.
Remote Ischemic Conditioning
Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
Control
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.
Control
Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min
Interventions
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Remote Ischemic Conditioning
Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
Control
Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Sherutei Briut Clalit
OTHER
Soroka University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Eldad Silberstein, MD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Locations
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Soroka University Medical Center
Beersheba, , Israel
Countries
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Central Contacts
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Other Identifiers
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SOR 265-16 CTIL
Identifier Type: -
Identifier Source: org_study_id
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