Leg Ulcer, Varicose Ulcer
Conditions
Keywords
chronic ulcer, diabetic ulcer, venous ulcer, remote ischemic conditioning
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
Interventions
PROCEDURERemote Ischemic Conditioning
Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
OTHERControl
Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min
Sponsors
Sherutei Briut Clalit
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 8 weeks | Wound closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Granulation | 8 weeks | Change of granulation of wound according to granulation scale |
| Wound rea change | 8 weeks | Change in % of wound area |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 8 weeks | Levels of IL 1 IL6 VEGF, NCD34, Adenosine |
Countries
Israel
Contacts
Primary ContactEldad Silberstein, MD
Backup ContactDavid Czeiger, MD
Outcome results
None listed