Pressure UlcerPOTER-OILNCT05144646
Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Press Ulcer (POTER-OIL)
A study of Pressure Ulcer, run by JOSE MIGUEL MORALES ASENCIO.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, aged > 20 years without functional limitation.
- BMI of 18.5-25.9 kg/cm2.
- No scars on the heels.
- Patients aged > 20.
- Patients with risk of deterioration of skin integrity according to Braden score <16.
- no presence of Press Ulcer.
Who cannot join
- Failure to meet all of the above criteria.
- Smokers.
- Consume high levels of alcohol (> 20g/week).
- Tattoos in the measurement areas.
- PHASE TWO - PATIENTS
- Presence of vasoactive drugs in infusion
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL, MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL
- Keywords
- Hyperoxygenated fatty acid, Olive oil, Prevention, Perfusion and Oxygenation
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROLOther
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.
MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROLOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | 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 Receives: Other: MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL |
| PATIENTS | Experimental | 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. Receives: Other: MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start4 Jan 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JOSE MIGUEL MORALES ASENCIO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JOSE MIGUEL MORALES ASENCIO, University of Malaga
- Investigators
- Inmaculada Lupiáñez Pérez, PhD, Principal investigator, Faculty of Health Sciences, University of Málaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144646
- Sponsor's protocol ID
- PI21/01197
- Acronym
- POTER-OIL
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avsar P, Moore Z, Patton D, O'Connor T, Budri AM, Nugent L. Repositioning for preventing pressure ulcers: a systematic review and meta-analysis. J Wound Care. 2020 Sep 2;29(9):496-508. doi: 10.12968/jowc.2020.29.9.496.
PubMed 32924821Bail K, Draper B, Berry H, Karmel R, Goss J. Predicting excess cost for older inpatients with clinical complexity: A retrospective cohort study examining cognition, comorbidities and complications. PLoS One. 2018 Feb 23;13(2):e0193319. doi: 10.1371/journal.pone.0193319. eCollection 2018.
PubMed 29474407Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1.
PubMed 23375662Diaz-Valenzuela A, Garcia-Fernandez FP, Carmona Fernandez P, Valle Canete MJ, Pancorbo-Hidalgo PL. Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial. Int Wound J. 2019 Dec;16(6):1314-1322. doi: 10.1111/iwj.13191. Epub 2019 Sep 2.
PubMed 31475465Ferris A, Price A, Harding K. Pressure ulcers in patients receiving palliative care: A systematic review. Palliat Med. 2019 Jul;33(7):770-782. doi: 10.1177/0269216319846023. Epub 2019 Apr 24.
PubMed 31018829Gallart, E., Fuentelsaz, C., Vivas, G., Garnacho, I., Font, L., & Arán, R. (2001). Estudio experimental para comprobar la efectividad de los ácidos grasos hiperoxigenados en la prevención de las úlceras por presión en pacientes ingresados. Enfermería Clínica, 11(5), 179-183. https://doi.org/10.1016/s1130-8621(01)73714-x
Gaspar S, Peralta M, Marques A, Budri A, Gaspar de Matos M. Effectiveness on hospital-acquired pressure ulcers prevention: a systematic review. Int Wound J. 2019 Oct;16(5):1087-1102. doi: 10.1111/iwj.13147. Epub 2019 Jul 1.
PubMed 31264345Gomez-Gonzalez AJ, Morilla-Herrera JC, Lupianez-Perez I, Morales-Asencio JM, Garcia-Mayor S, Leon-Campos A, Marfil-Gomez R, Aranda-Gallardo M, Moya-Suarez AB, Kaknani-Uttumchandani S. Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study. J Adv Nurs. 2020 Feb;76(2):654-663. doi: 10.1111/jan.14250. Epub 2019 Nov 20.
PubMed 31651050Jull A, McCall E, Chappell M, Tobin S. Measuring hospital-acquired pressure injuries: A surveillance programme for monitoring performance improvement and estimating annual prevalence. Int J Nurs Stud. 2016 Jun;58:71-79. doi: 10.1016/j.ijnurstu.2016.02.005. Epub 2016 Feb 17.
PubMed 27087299Lazaro-Martinez JL, Lopez-Moral M, Garcia-Alamino JM, Bohbot S, Sanz-Corbalan I, Garcia-Alvarez Y. Evolution of the TcPO2 values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial. J Wound Care. 2021 Jan 2;30(1):74-79. doi: 10.12968/jowc.2021.30.1.74.
PubMed 33439078Lechner A, Kottner J, Coleman S, Muir D, Beeckman D, Chaboyer W, Cuddigan J, Moore Z, Rutherford C, Schmitt J, Nixon J, Balzer K. Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research. Br J Dermatol. 2021 Apr;184(4):617-626. doi: 10.1111/bjd.19304. Epub 2020 Jul 27.
PubMed 32510579Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.
PubMed 32113142Lindgren M, Malmqvist LA, Sjoberg F, Ek AC. Altered skin blood perfusion in areas with non blanchable erythema: an explorative study. Int Wound J. 2006 Sep;3(3):215-23. doi: 10.1111/j.1742-481X.2006.00238.x.
PubMed 16984577Lovegrove J, Fulbrook P, Miles SJ, Steele M. Effectiveness of interventions to prevent pressure injury in adults admitted to acute hospital settings: A systematic review and meta-analysis of randomised controlled trials. Int J Nurs Stud. 2021 Oct;122:104027. doi: 10.1016/j.ijnurstu.2021.104027. Epub 2021 Jun 30.
PubMed 34334175Lovegrove J, Fulbrook P, Miles S, Steele M. Effectiveness of interventions to prevent pressure injury in adults admitted to intensive care settings: A systematic review and meta-analysis of randomised controlled trials. Aust Crit Care. 2022 Mar;35(2):186-203. doi: 10.1016/j.aucc.2021.04.007. Epub 2021 Jun 16.
PubMed 34144865
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05144646
- Acronym / sponsor ID
- POTER-OIL / PI21/01197
- Conditions
- Pressure Ulcer
- Keywords
- Hyperoxygenated fatty acid, Olive oil, Prevention, Perfusion and Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- JOSE MIGUEL MORALES ASENCIOUniversity, hospital or other
- Study start
- 4 Jan 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | Other: MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROLWith 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 |
| PATIENTS | Experimental | Other: MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROLWith 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers, aged > 20 years without functional limitation.
- BMI of 18.5-25.9 kg/cm2.
- No scars on the heels.
- Patients aged > 20.
- Patients with risk of deterioration of skin integrity according to Braden score <16.
Key exclusion criteria (10 listed)
- Failure to meet all of the above criteria.
- Smokers.
- Consume high levels of alcohol (> 20g/week).
- Tattoos in the measurement areas.
- PHASE TWO - PATIENTS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROLThe 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. | Other | HEALTHY SUBJECTS |
| MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROLIn 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. | Other | PATIENTS |
Primary outcome
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.
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%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Background: PubMed 32924821Avsar P, Moore Z, Patton D, O'Connor T, Budri AM, Nugent L. Repositioning for preventing pressure ulcers: a systematic review and meta-analysis. J Wound Care. 2020 Sep 2;29(9):496-508. doi: 10.12968/jowc.2020.29.9.496.
- Background: PubMed 29474407Bail K, Draper B, Berry H, Karmel R, Goss J. Predicting excess cost for older inpatients with clinical complexity: A retrospective cohort study examining cognition, comorbidities and complications. PLoS One. 2018 Feb 23;13(2):e0193319. doi: 10.1371/journal.pone.0193319. eCollection 2018.
- Background: PubMed 23375662Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1.
- Background: PubMed 31475465Diaz-Valenzuela A, Garcia-Fernandez FP, Carmona Fernandez P, Valle Canete MJ, Pancorbo-Hidalgo PL. Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial. Int Wound J. 2019 Dec;16(6):1314-1322. doi: 10.1111/iwj.13191. Epub 2019 Sep 2.
- Background: PubMed 31018829Ferris A, Price A, Harding K. Pressure ulcers in patients receiving palliative care: A systematic review. Palliat Med. 2019 Jul;33(7):770-782. doi: 10.1177/0269216319846023. Epub 2019 Apr 24.
- BackgroundGallart, E., Fuentelsaz, C., Vivas, G., Garnacho, I., Font, L., & Arán, R. (2001). Estudio experimental para comprobar la efectividad de los ácidos grasos hiperoxigenados en la prevención de las úlceras por presión en pacientes ingresados. Enfermería Clínica, 11(5), 179-183. https://doi.org/10.1016/s1130-8621(01)73714-x
- Background: PubMed 31264345Gaspar S, Peralta M, Marques A, Budri A, Gaspar de Matos M. Effectiveness on hospital-acquired pressure ulcers prevention: a systematic review. Int Wound J. 2019 Oct;16(5):1087-1102. doi: 10.1111/iwj.13147. Epub 2019 Jul 1.
- Background: PubMed 31651050Gomez-Gonzalez AJ, Morilla-Herrera JC, Lupianez-Perez I, Morales-Asencio JM, Garcia-Mayor S, Leon-Campos A, Marfil-Gomez R, Aranda-Gallardo M, Moya-Suarez AB, Kaknani-Uttumchandani S. Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study. J Adv Nurs. 2020 Feb;76(2):654-663. doi: 10.1111/jan.14250. Epub 2019 Nov 20.
- Background: PubMed 27087299Jull A, McCall E, Chappell M, Tobin S. Measuring hospital-acquired pressure injuries: A surveillance programme for monitoring performance improvement and estimating annual prevalence. Int J Nurs Stud. 2016 Jun;58:71-79. doi: 10.1016/j.ijnurstu.2016.02.005. Epub 2016 Feb 17.
- Background: PubMed 33439078Lazaro-Martinez JL, Lopez-Moral M, Garcia-Alamino JM, Bohbot S, Sanz-Corbalan I, Garcia-Alvarez Y. Evolution of the TcPO2 values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial. J Wound Care. 2021 Jan 2;30(1):74-79. doi: 10.12968/jowc.2021.30.1.74.
- Background: PubMed 32510579Lechner A, Kottner J, Coleman S, Muir D, Beeckman D, Chaboyer W, Cuddigan J, Moore Z, Rutherford C, Schmitt J, Nixon J, Balzer K. Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research. Br J Dermatol. 2021 Apr;184(4):617-626. doi: 10.1111/bjd.19304. Epub 2020 Jul 27.
- Background: PubMed 32113142Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada Lupiáñez Pérez, PhD principal investigator
Faculty of Health Sciences, University of Málaga, Spain
Questions about this trial
What is this clinical trial studying?
A study of Pressure Ulcer, run by JOSE MIGUEL MORALES ASENCIO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Lupiáñez Pérez, PhD (651563914, inmalupianez@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144646, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.