Remote Ischemic Conditioning for Treatment of Chronic Wounds

Leg Ulcer Clinical Trial

Official title:

Remote Ischemic Conditioning for Treatment of Chronic Wounds

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02873728
• Other study ID #: SOR 265-16 CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 17, 2016
• Start date: November 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2016
• Source: Soroka University Medical Center
• Contact: Eldad Silberstein, MD
• Phone: +972-8-6400880
• Email: eldads[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Procedure:
• Remote Ischemic Conditioning
Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff

Other:
• Control
Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Sherutei Briut Clalit

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Levels of IL 1 IL6 VEGF, NCD34, Adenosine	8 weeks	No
Primary	Wound Healing	Wound closure	8 weeks	No
Secondary	Granulation	Change of granulation of wound according to granulation scale	8 weeks	No
Secondary	Wound rea change	Change in % of wound area	8 weeks	No