Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Press Ulcer (POTER-OIL)

Study Overview
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Brief Summary
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The study objectives will be: Primary objectives: To determine the effects on oxygenation and tissue perfusion of applying HFA (Hyperoxygenated Fatty Acids) or EVOO (Extra Virgin Olive Oil) to the heels of healthy subjects, evaluating the maximum variation of oxygenation and flow when the heels are subjected to pressure. To determine the levels of tissue oxygenation and perfusion associated with the appearance of blanching erythema in the heels of acute hospitalised patients and patients admitted to social health centers for the elderly. Secondary objectives: To determine whether there are differences in oxygenation and peripheral tissue perfusion between heels to which HFA vs. EVOO is applied. To evaluate the possible progressive loss of the efficacy of HFA and EVOO in terms of tissue oxygenation and perfusion in patients who are bedridden for extended periods. Methodology: Experimental study in two phases: preclinical and clinical. Phase 1 with healthy subjects, with a randomized and open design, with an intrasubject control group. Phase 2 with hospitalized subjects and patients admitted to social health centers for the elderly, with a randomized and open design, with an intrasubject control group.

Detailed Description
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The study participants will be subjected to simple randomisation to receive HFA or EVOO . The phase 1 will be carried out in healthy volunteers recruited at the Faculty of Health Sciences in the University of Malaga (Spain). Inclusion criteria: Healthy volunteers, aged >20 years, with no cardiovascular, neurological, digestive, endocrine, renal, gynaecological, respiratory, haematological, infectious, dermatological, autoimmune or osteomuscular diseases diagnosed, nor functional limitations, with objective tissue integrity, BMI of 18.5-25.9 kg/cm2 and no scars on the heels. The phase 2 will be carried out patients admitted to acute hospitalised patients and patients admitted to social health centers for the elderly, at risk of deterioration of skin integrity according to Braden score <16, no presence of PU, who agree to participate in the study. Measurement instruments Perfusion and tissue temperature data will be obtained by laser doppler flowmetry (LDF), with MoorVMS-LDF equipment. This system has two monitoring probes (one for each heel) that are brought into contact with the skin. The laser light is transmitted through an optical fibre to the tissue, reaching a depth of approximately 1 mm. The scattered light is collected by optical fibres and, at the same time, transmitted to a photodetector. The system has a measuring range of 5-50º C, a resolution of 0.1º C and an accuracy of ± 0.3º C. Tissue oxygenation will be measured by near-infrared spectroscopy, with the MoorVMS-NIRS instrument. As in the previous case, the system contains two monitoring probes that are placed in contact with the skin. This method measures oxygen saturation (SpO2), which is calculated from absolute concentrations of oxygenated and deoxygenated haemoglobin in the tissue. Each probe consists of a detector head, containing two identical photodiodes, and an emitter head, with two infrared LEDs that emit light at approximately 750-850 nm. The system has a measurement range of 0-99%, a resolution of 1% and an accuracy of ± 3%. All information on capillary blood flow, local temperature and tissue oxygenation will be monitored continuously and simultaneously using appropriate software. All measurement procedures are non-invasive. Both Moor instruments are certified to ISO 13485: 2016.

Official Title
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Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Deterioration of Skin Integrity Subjected to Treatment With Hyperoxygenated Fatty Acids vs Virgin Olive Oil

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Other: MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL
* Other: MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL


Participation Criteria
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Eligibility Criteria
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PHASE ONE HEALTHY SUBJECTS Inclusion criteria: Healthy volunteers, aged > 20 years without functional limitation. BMI of 18.5-25.9 kg/cm2. No scars on the heels. Exclusion criteria: Failure to meet all of the above criteria. Smokers. Consume high levels of alcohol (> 20g/week). Tattoos in the measurement areas. PHASE TWO - PATIENTS Inclusion criteria: Patients aged > 20. Patients with risk of deterioration of skin integrity according to Braden score <16. no presence of Press Ulcer. Exclusion criteria: Presence of vasoactive drugs in infusion Subjects with a pacemaker and/or implanted defibrillator. Fever and anaemia with Hb <10 g/dl. Hypotension with systolic blood pressure <80 mmHg. Transfusion during the last four weeks.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEALTHY SUBJECTS<br>With healthy subjects in a randomised, open experimental design, in an intrasubject control group (application of HFA / EVOO on one heel, using the contralateral heel as a control and evaluating oxygenation and tissue perfusion in both cases). This intervention would correspond to phase 1 | Other: MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL<br>* The corresponding product (HFA -Mepentol®- or EVOO - Farmaoliva®- depending on the study group assigned) will be applied to the subject's right heel, while the contralateral, left, heel will remain as a control. To ensure that the product is completely absorbed into the skin, the subject will then be asked to remain lying face up, at an angle of 30º to the bed, for one hour. The Doppler and infrared laser probes will then be placed on each heel (on the calcaneal tuberosity), for approximately four hours. The subjects will be asked to keep their lower body immobile, but will be able to move their arms and neck gently. Average values for capillary blood flow, local temperature and tissue oxygenation will be collected at 15-minute intervals, although the first 15-minute reading, while the parameters are becoming established, will be discarded.<br>|
| Experimental: PATIENTS<br>With hospitalised patients and patients from social and health centers an experimental, randomised, open design, also with an intrasubject control group (application of HFA / EVOO on one heel, using the contralateral heel as a control and evaluating oxygenation and tissue perfusion in both cases). This intervention would correspond to phase 2. | Other: MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL<br>* In the second, clinical phase, the measurement protocol will be different, although certain aspects will remain unchanged. The product in question (HFA -Mepentol®- or EVOO -Farmaoliva®- according to the randomisation group assigned) will be applied to the intervention heel (right), leaving the contralateral (left) heel as a control. In addition, every patient will receive the standard PU prevention measures described in the protocol applicable for persons at risk of this condition. The intervention will be carried out in the morning, after bathing, as is customary in acute-care hospital units. The data will be collected at 15-minute intervals, although the first interval will be discarded, as described above. This procedure will be repeated every day during hospitalisation, to assess the cumulative action of the barrier cream. Each measurement will last approximately one hour each day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion and tissue temperature | Perfusion and tissue temperature data will be obtained by laser doppler flowmetry (LDF), with MoorVMS-LDF equipment. This system has two monitoring probes (one for each heel) that are brought into contact with the skin. The laser light is transmitted through an optical fibre to the tissue, reaching a depth of approximately 1 mm. The scattered light is collected by optical fibres and, at the same time, transmitted to a photodetector. The system has a measuring range of 5-50º C, a resolution of 0.1º C and an accuracy of ± 0.3º C. | In the healthy group, measurements will be made for four hours at fifteen-minute intervals for 1 day. In the hospitalized patients group, measurements will be made for one hour at fifteen-minute intervals every day for 7 days. | 
| Tissue oxygenation | Tissue oxygenation will be measured by near-infrared spectroscopy, with the MoorVMS-NIRS instrument. As in the previous case, the system contains two monitoring probes that are placed in contact with the skin. This method measures oxygen saturation (SpO2), which is calculated from absolute concentrations of oxygenated and deoxygenated haemoglobin in the tissue. Each probe consists of a detector head, containing two identical photodiodes, and an emitter head, with two infrared LEDs that emit light at approximately 750-850 nm. The system has a measurement range of 0-99%, a resolution of 1% and an accuracy of ± 3%. | In the healthy group, measurements will be made for four hours at fifteen-minute intervals for 1 day. In the hospitalized patients group, measurements will be made for one hour at fifteen-minute intervals every day for 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperoxygenated fatty acid, Olive oil, Prevention, Perfusion and Oxygenation