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

November 19, 2021 updated by: JOSE MIGUEL MORALES ASENCIO

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

The study objectives will be:

Primary objectives:

  1. 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.
  2. 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:

  1. To determine whether there are differences in oxygenation and peripheral tissue perfusion between heels to which HFA vs. EVOO is applied.
  2. 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEALTHY SUBJECTS
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
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.
Experimental: PATIENTS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion and tissue temperature
Time Frame: 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.
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
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOSE MIGUEL MORALES ASENCIO

Investigators

  • Principal Investigator: Inmaculada Lupiáñez Pérez, PhD, Faculty of Health Sciences, University of Málaga, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 4, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI21/01197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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