Clinical trial NCT02873728: Remote Ischemic Conditioning for Treatment of Chronic Wounds
Official title: Remote Ischemic Conditioning for Treatment of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Ulcer
Varicose Ulcer
Keywords: chronic ulcer
diabetic ulcer
venous ulcer
remote ischemic conditioning
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Sherutei Briut Clalit
First posted: 2016-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Wound Healing
timeFrame: 8 weeks
Secondary outcomes:
measure: Granulation
timeFrame: 8 weeks
measure: Wound rea change
timeFrame: 8 weeks
Other outcomes:
measure: Biomarkers
timeFrame: 8 weeks
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Eldad Silberstein, MD
role: PRINCIPAL_INVESTIGATOR
References: