Remote Ischemic Conditioning for Treatment of Chronic Wounds

Sponsor

Soroka University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02873728

Collaborator

Sherutei Briut Clalit (Other)

200

Enrollment

Location

Arms

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Ulcer Varicose Ulcer	Procedure: Remote Ischemic Conditioning Other: Control	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Remote Ischemic Conditioning for Treatment of Chronic Wounds

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Remote Ischemic Conditioning Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
Sham Comparator: 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.	Other: Control Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Remote Ischemic Conditioning

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

Sham Comparator: 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.

Other: Control

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

Outcome Measures

Primary Outcome Measures

Wound Healing [8 weeks]
Wound closure

Secondary Outcome Measures

Granulation [8 weeks]
Change of granulation of wound according to granulation scale
Wound rea change [8 weeks]
Change in % of wound area

Other Outcome Measures

Biomarkers [8 weeks]
Levels of IL 1 IL6 VEGF, NCD34, Adenosine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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